Copper pyrithione - Europadissemination.echa.europa.eu/Biocides/ActiveSubstances/... · 2016-02-10 · Coppel' pyrithione Septembel' 2014 Final CAR Doc IIIA4 Determination of the

Competent Authority Report According to Directive 98/8/EC

Copper pyrithione CAS 14915-37-8

Active substance in Biocidal Products

Product Type 21 (Antifouling products)

Applicant: Arch Chemicals Inc.

DOCUMENT III A Section 4: Analytical Methods for Identification and Detection

Rapporteur Member State: Sweden

Final CAR September 2014

2 (49)

Table of Contents; DOC III-A Section 4

Section A.4 Analytical Methods for Detection and Identification ........................................................ 3

Section A4.1/01 Determination of the pure active substance and impurities in the technical material ...... 3



Section A4.2(a)/01 Determination of residues in soil .................................................................................... 11

Section A4.2(b)/01 Determination of residues in air ...................................................................................... 16

Section A4.2(b)/02 Determination of residues in air ...................................................................................... 19

Section A4.2(c)/01 Determination of residues in water (fresh water) ............................................................ 24

Section A4.2(c)/02 Determination of residues in water (drinking) ................................................................ 28

Section A4.2(c)/03 Determination of residues in water (seawater) ................................................................ 32

Section A4.2(d)/01 Determination of residues in animal and human body fluids and tissues (plasma) ........ 36

Section A4.2(d)/02 Determination of residues in animal and human body fluids and tissues ...................... 41

Section A4.3/01 Determination of residues in/on food or feedstuffs ......................................................... 43

Reference list of studies submitted by Section No. ............................................................................................... 48

Reference list of studies submitted by Author ...................................................................................................... 49

Al'ch Chemicals Inc .. RMS: Sweden

Section A.4

Section A4.1/01

Annex Point IIA, IV.4.1

1.1 Reference

1.2 Data pl'otection

1.2. l Data owner

1.2.2 Companies with letter of access

1.2.3 Criteria for data protection

2.1 Guideline study

2.2 GLP

2.3 Deviations

3.1 Pl'eliminal'y tl'eatment

3.1.1 Enriclunent

3.1.2 Cleanup

3.2 Detection

3.2.1 Separation method

3.2.2 Detector

3.2.3 Standard

3.2.4 Interfering substance

3.3 Lineal"ity

3.3.1 Calibration range

3.3.2 Number of

Coppel' pyrithione Septembel' 2014

Analytical Methods for Detection and Identification

Determination of the pure active substance and impur ities in the technical material

Active substance

1. REFERENCE

Document IV ARCPT 4010-001

Final CAR Doc III A4

Official use only

•••• (2006) Copper Pyrithione - 5 Batch characterisation, ITS Testing Services (UK) Ltd. Study Number 1298506 (unpublished)

• -2. GUIDELINES AND QUALITY ASSURANCE

OPPTS 830.1700

Yes

None

3. MATERIALS AND METHODS

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Section A4.1/01


mea.sm·ements

3.3.3 Linearity

3.4 Specifity: interfering substances

3.5 Recovel'y rates at diffel'ent levels

3.5.1 Relative standard deviation

3.6 Limit of determination

3.7 Pl'ecision

3.7.1 Repeatability

Coppel' pyrithione August 2013

Determination of the pure active substance and impurities in the technical material

Active substance

3.7.2 Independent -laboratory validation

4.1 M aterials and methods

4.2 Conclusion

4.2.1 Reliability

4.2.2 Deficiencies

4. APPLICANT'S SUMMARY AND CO NCLUSION

The method may be used to assay TGAI copper pyrithione

I No

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Section A4.1/01


Date

Materials and methods

Conclusion

Reliability

Acceptability

Rema1·ks



Active substance

Evaluation by Competent Authorities

EVALUATION BY RAPPORTEUR MEMBER STATE

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CAR DocIIIA4

Arch Chemicals Inc.

RMS: Sweden

Copper pyrithione

September 2014

Final CAR

Doc III A4

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Section A4.1/02 Determination of the pure active substance and

impurities in the technical material

Annex Point IIA, IV.4.1 Impurities

The validation data for the analysis of impurities in the technical copper

pyrithione is confidential information and is presented in the Annex

Confidential Data and Information


Section A4.1/03


1.1 Refel'ence

1.2 Data pl'otection

1.2. l Data owner

1.2.2 Companies with letter of access


2.1 Guideline study

2.2 GLP

2.3 Deviations


3.1.1 Enrichment

3.1.2 Cleanup

3.2 Detection


3.2.2 Detector

3.2.3 Standard

3.2.4 Interfering substance

3.3 Linea1·ity

3.3.l Calibration range

3.3.2 Number of measurements


Final CAR Doc IIIA4


Assay of TGAI in AF fol'mulations

1. REFERENCE


- (2003) Validation of analytical method: HPLC detemiination of copper pyrithione in marine antifouling paints, Arch Cheniicals, Inc. Cheshire, CT, Repo1t No. CASR-03-2003 (m1published) --2. GUIDELINES AND QUALITY ASSURANCE

Not applicable

Not applicable

Not applicable


----

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Official use only

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Section A4.1/03


3.3.3 Linearity

3.4 Specifity: intel'fering substances



3.6 Limit of detel'mination

3.7 Pl'ecision

3.7.1 Repeatability

3.7.2 Independent




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X3

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Section A4.1/03


laboratory validation

4.1 Materials and methods

4.2 Conclusion

4.2.l Reliability

4.2.2 Deficiencies

Date


Conclusion

Reliability




4. APPLICANT'S SUMMARY AND CONCLUSION

[CONFIDENTIAL INFORMATION EXCLUDED] .

CAR DocIIIA4

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The method may be used for analysis of copper pyrithione in paint in the range of0.5% - 7.5%.

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No



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Section A4.1/03


Ac.ceptability

Rema1·ks




•

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CAR DocIIIA4



Final CAR DocIIIA4

Section A4.2(a)/01

Annex Point IIA, IV.4.2(a)

1.1 Refel'ence

Determination of residues in soil

1 REFERENCE


••• (2004) Method for the analysis of pyrithione in sediment by HPLC with MS/MS detection. Arch Chemicals, Inc. Cheshire, CT, USA, Report No. CASR-01-2004 (unpublished)

1.2 Data pl'otec.tion •

1.2.1 Data owner

1.2.2 Companies with letter -of access


2.1 Guideline study

2.2 GLP

2.3 Deviations

3.1 Pl'eliminal'y ti·eatment

3 .1.1 Enrichment

3.1.2 Cleanup

3.2 Detection


3.2.2 Detector

2 GUIDELINES AND QUALITY ASSURANCE

Not applicable

Not applicable

Not applicable

3 MATERIALS AND METHODS

-

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Official use only

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Section A4.2(a)/01 Determination of residues in soil

Annex Point IIA, IV.4.2(a) Zinc pyrithione

3.2.3 Standard( s)

3.2.4 Interfering substance( s)

3.3 Linea1·ity

3.3.l Calibration range


3.3.3 Linearity

3.4 Specifity: interfering substances

3.5 Recovery rates at diffel'ent levels

3.5. l Relative standard deviation


3. 7 Pl'ecision

3. 7 .1 Repeatability

-I

-


4 APPLICANT 'S SUMMARY AND CONCLUSION

4.1 M aterials and methods

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4.2 Conclusion

4.2. l Reliability

4.2.2 Deficiencies


CAR Doc IIIA4


The method was validated with sediment, but also applies to analysis of pyrithione in soils since the matrix is similar and variations in extraction efficiency are compensated for by the intemal standard.

Pyrithione fonns strong complexes with various metal ions (e.g., zinc, copper, and iron) and may also complex with metallic or other cationic sites in the sediment. Although the concentration of pyrithione in sediment or soil may be expressed for convenience as the e.quivalent concentration of it is impo1tant to understand that at low concentrations in sediment (and the similar mati·ix, soil) do not exist as a single compounds. This may be deduced from the general chemistry of chelation compounds. As discussed in the section on fate and behavior in water, experimental data exist that show in water readily trnnschelates to copper pyrithione in the presence of copper(II). Soil and sediment are much more complex matrices, containing a variety of charged sites and various metal ions at concentrations much higher those predicted for pyrithione. Evidence that both compounds dissociate and interact with the sediment to fonn a. common set of pyrithione complexes was obta.ined from aquatic metabolism studies conducted with which showed that both compounds degraded at the same rate and the degradation products exhibited the same pattem of formation and decline.

I No



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XI


Section A4.2(a)/01


Date


Conclusion

Reliability

Acceptability

Rema1·ks



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Table A4.2(a)/01: Charactel'istics of the sediment (loamy-sand) used in the validation (Rittel', 2004)

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Arch Chemicals Inc .. RMS: Sweden

Section A4.2(b )/01

Annex Point IIA, IV.4.2(b)

1.1 Refer ence

Copper pyrithione September 2014

Determination of residues in air

1. REFERENCE


- (2001) Analysis of on sample collection media in suppo1t of an application occupational exposure study. Arch Chemicals, Inc., Study Number 73-00B lOCuPT (unpublished)

1.2 Data protection •

1.2 . l Data owner

1.2 .2 Companies with letter -of access

1.2 .3 Criteria for data protection

2.1 Guideline study

2.2 GLP

2.3 Deviations

3.1 P1·elhnina1-y treatment

3 .1.1 Extraction

3 .1.2 Cleanup

3.2 Detection

3.2 . l Separation method

2. GUIDELINES AND QUALITY ASSURANCE

Not applicable

Not applicable

Not applicable


--

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Final CAR Doc IIIA4

Official use only

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Copper pyrithione August 2013

Section A4.2(b )/01 Determination of residues in air

Annex Point IIA, IV.4.2(b) Copper p y1ithlone

3.2.2 Dete.ctor

3.2.3 Standard( s)

3.2.4 Interfering substance(s)

3.3 Linea1ity


3.3.2 Nwnber of I measurements

3.3.3 Linearity

3.4 Specificity : intedering substances

3.5 Recove1·y rates at different levels



3.7 Precision

3. 7 .1 Repeatability

3.7.2 Independent -labora.to1y validation


4. APPLICANT'S SUMMARY AND CONCLUSION

[CONFIDENTIAL Il'i"FORMATION EXCLUDED] .

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Section A4.2(b )/01 Determination of residues in air

Annex Point IIA, IV.4.2(b) Copper py1ithlone

4.2 Conclusion

4.2. l Reliability

4.2.2 Deficiencies

Date


Conclusion

Reliability

Ac.ceptability

Rema1·ks

The method is applicable for quantitation of copper pyrithione in the range of0.5 µg to 200 µg collected on the sampling filters.

I

None



•

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Section A4.2(b )/02


1.1 Reference

1.2

1.2.1

1.2.2

1.2.3

2.1

2.2

2.3

Data pl'otection

Data ov.111er

Companies with letter of access

Criteria for data protection

Guideline study

GLP

Deviations



CAR Doc III A4


1 REFERENCE

Document IV EZPTF 4020-006

• (2007) Analytical method validation for the determination of

•••• in air sampling collection media, Arch Chemicals, Inc., Cheshire, CT, USA, Identification No. CASR-05-2007 (unpublished) .

• -2 GUIDELINES AND QUALITY ASSURANCE

Not applicable

Yes

No


Official use only

3.1.1 Enrichment -

3.1.2 Cleanup -

3.2 Detection

3.2.1 Separntion method

3.2.2 Detector

3.2.3 Standard(s)

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Section A4.2(b )/02



3.3 Lineal'ity



3.3.3 Linearity

3.4 Specificity: intel'fering substances



3.6 Limit of detel'mination

3.7 Pl'ecision

3.7.1 Repeatability

3.7.2 Independent laborato1y validation

4.1 M atel'ials and methods

4.2 Conclusion


CAR Doc IIIA4


-

-4 APPLICANT 'S SUMMARY AND CONCLUSION

This method is suitable for measurement of······ concentrations in air using air sampling filters. The limit of quantitation is 0.2 µg colle.cted on the filter. The con-esponding air concentration depends on the volume of air sampled. No breakthrough occtmed at a flow rate of 1.5 Uminute for 5 hours, con-esponding to

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Section A4.2(b )/02


4.2.1 Reliability


CAR Doc IIIA4


450 liters sampled. The LOD in air is therefore at least 0.44 µg/m3.

The instmmentation required to perfonn the analysis is available in most well equipped analytical laboratories. No toxic or hazardous reagents are required to prepare the samples, and all of the sample preparation equipment is commercially available. The method does not require the use of tmtreated commodity to coITect for recoveries.

The method uses - as the external calibration standard, but the derivative reacts with the pyrithione portion of the molecule. The method is therefore applicable to measmement ofNaPT and CuPT as well as ZnPT. Results expressed as ZnPT concentration can be converted to CuPT or NaPT concentrations by applying the appropriate molecular weight ratio.

NaPT concentrntion = - concentration) x (2) x (149.15) I (317 .67)

CuPT concentrntion = ~concentration) x (315.86) I (317 .67)

I X6

4.2.2 Deficiencies No



Date


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Section A4.2(b )/02




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Section A4.2(b )/02


Conc.lusion

Reliability

Ac.ceptability

Rema1·ks



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Section A4.2(c)/01

Annex Point IIA, IV.4.2(c)

1.1 Reference

1.2 Data protection

1.2 .1 Data owner

1.2 .2 Companies with letter of access


2.1 Guideline study

2.2 GLP

2.3 Deviations

3.1 P1·elimina1-y treatment

3.1.l Extraction

3.1.2 Cleanup

3.2 Detection



Determination of residues in water (fresh water)

1. REFERENCE


••••••• (2003) Detemlination of copper pyrithione in freshwater by high performance liquid chromatography. Method validation at 0.1 µg/L concentrntion. Arch Chemicals, Inc. Cheshire, CT, USA, Report No. CASR-02-2003 (unpublished)

-2. GUIDELINES AND QUALITY ASSURANCE

Not applicable

Not applicable

Not applicable


--

24 (49)

Final CAR Doc IIIA4

Official use only

Xl


Section A4.2(c)/01


3.2 .2 Detector

3.2 .3 Standard( s)


3.3 Linea1ity

3.3. 1 Calibration range

3.3.2 Nwnber of measurements

3.3.3 Linearity

3.4 Specificity: intel"fering substances

3.5 Recovery rntes at differ ent levels



3.7 Precision

3.7. l Repeatability

3.7.2 Independent laboratory validation


4.2 Conclusion


CAR Doc IIIA4


I

-4. APPLICANT'S SUMMARY AND CONCLUSION


This method is suitable for use by regulato1y agencies to detect pyrithione in SW'face and drinking water. The instrumentation required to perform the analysis is available in most well equipped analytical laboratories. No toxic or hazardous reagents are required to prepare the samples, and all of the sample preparation equipment is commercially available. The method does not require the use of untreated commodity to correct for recoveries.

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4 .2 . l Reliability



I

4.2 .2 Deficiencies No


Date

Matel'ials and methods

-

Conc.lusion

Reliability

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Section A4.2(c)/01


Acceptability

Remal'ks



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Section A4.2(c)/02


1.1 Refe1·ence

1.2

1.2. l

1.2.2

1.2.3

2.1

2.2

2.3

Data pl'otection

Data owner



Guideline study

GLP

Deviations

3.1 Pl'eliminal'y treatment


CAR Doc IIIA4

Determination of residues in water (drinking)

1 REFERENCE


••• (2007) Method for the analysis of copper pyrithione in drinking water by HPLC with MS/MS detection. Arch Chemicals, Inc. Cheshire, CT, USA, Report No. CASR-07-2007 (unpublished)


Not applicable

Not applicable

Not applicable


Official use only

Xl

3 .1.1 Enrichment -

3.1.2 Cleanup -

3.2 Detection


3.2.2 Detector

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Section A4.2(c)/02


3.2.3 Standard( s)


3.3 Linea1·ity



3.3.3 Linearity

3.4 Specificity: intel'fering substances

3.5 Recovel'y rates at different levels



3.7 Pl'ecision

3.7.1 Repeatability




CAR DocIIIA4


-I

• -4 APPLICANT'S SUMMARY AND CONCLUSION

Extenal standards are prepared at concentrations of 0.0498, 0.0996 0.249, 0.996, 2.49, and 9.96 µg/L in HPLC grade water. One milliter of each standard and each water sample a.re derivatized by addition of l 0 ul of a 20-mg/ml solution of the derivatizing reagent •••• ••••••••••••••••••• After a reaction time of20 minutes a.t 65 dgerees C, 60 µL of each are injected onto the HPLC co1Ull11l. The pyrithione derivative elutes with a. retention time of3.9 - 4.0 minutes.

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Section A4.2(c)/02


4.2 Conclusion



CAR Doc IIIA4

A linear least squares analysis of the standards concentration vs. peak area (l /x weighting) is used to calculate the copper py:rithione concentration in the samples.

The method was validated using residential well water. This method is X8 suitable for use by regulatory agencies to detect copper pyrithione in surface and drinking water. The instrumentation required to perfonn the analysis is available in most well equipped analytical laboratories. No toxic or hazardous reagents are required to prepare the samples, and all of the sample preparation equipment is commerciaily available. The method does not require the use of untreated commodity to coffe.ct for recovenes .

4.2.1 Reliability I

4.2.2 Deficiencies no


Date


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Section A4.2(c)/02


Conclusion

Reliability

Accep tability

Rema1·ks



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Section A4.2(c)/03


1.1 Refe1·ence

1.2

1.2. l

1.2.2

1.2.3

2.1

2.2

2.3

Data pl'otection

Data owner



Guideline study

GLP

Deviations



CAR Doc IIIA4

Determination of residues in water (seawater)

1 REFERENCE

Document IV EZPTF 4020-008

••• (2009) Method for the analysis of pyrith.ione in seawater by HPLC with MS/MS detection. Arch Chemicals, Inc. Cheshire, CT, USA, Repo1t No. CASR-02-2009 (unpublished)

• -2 GUIDELINES AND Q UALITY ASSURANCE

Not applicable

Not applicable

Not applicable


Official use only

3 .1.1 Enriclunent -

3.1.2 Cleanup -

3.2 Detection

3.2.1 Separation method X l

-

3.2.2 Detector

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Section A4.2(c)/03


3.2.3 Standard(s)


3.3 Lineal"ity


3.3.2 Number of measw-ements

3.3.3 Linearity

3.4 Specificity: interfering substances

3.5 Recovery rates at different levels



3.7 Precision

3.7.1 Repeatability



-I

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Section A4.2(c)/03


3.7.2 Independent

4.1

laborato1y validation


4.2 Conclusion

4.2.1 Reliability

4.2.2 Deficiencies

Date




-4 APPLICANT'S SUMMARY AND CONCLUSION

CAR Doc IIIA4

The method uses intemal standard calibration. Standards are prepared contammg at 5-6 concentration levels in the range of 0.05 to 10 µg/L in HPLC grade water. Three-milliliter aliquots of each standard and sample are spiked with ••••••••••• (intemal standard) at a concentration of 0.4 ug/L and derivatized by addition of 15 µL of a 20-mg/ml solution of the derivatizing reagent ••••••••••••••••••• After a reaction time of20 minutes at 65° C, 50 µL of each are analyzed by HPLC with detection by positive ion electrospray ionization mass spectrometry in the multiple reaction monitoring scan mode. The pyrithione derivative elutes with a retention time of·····

A linear least squares analysis (l/x weighting) of the standard concentration vs. the /IS peak area ratio is used to calculate the concentration in the samples.

The method was validated using sea.water. The instrumentation required to perform the analysis is available in most well equipped analytical laboratories. No toxic or hazardous reagents are required to prepare the samples, and all of the sample preparation equipment is commercially available. The method does not require the use of untreated commodity to cotl'ect for recoveries.

I no


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Section A4.2(c)/03


Conclusion

Reliability

Accep tability

Rema1·ks



-

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CAR Doc IIIA4


Section A4.2( d)/01

Annex Point IIA, IV.4.2(d)

1.1 Refer ence

1.2 Data protection

1.2 .l Data owner

1.2 .2 Companies with letter of access


2.1 Guideline s tudy

2.2 GLP

2.3 Deviations

3.1 Prelimina1·y treatment

3.1.1 Extr action

3.1.2 Cleanup

3.2 Detection


Final CAR Doc IIIA4

Determination of residues in animal and human body fluids and tissues (plasma)

1. REFERENCE

Document IV E ZPTF 4020-004, EXPTF 4020-005

- (2002) Quantitation of total pyrithione in rat plasma via HPLC with MS/MS detection. PPD Development, Richmond, VA, USA, Method No. LCMSC 2 18 Version 1.00 (llllpublished)

•••• (2003) Validation of a high-perfonnance liquid chromatography/mass spectrometry method for the analysis of total pyrithj ione in rat plasma. PPD Development, Richmond, VA, USA, Validation Report No. LCMSC 218 Version 1.00 (tmpublished)

•

-2. GUIDELINES AND Q UALITY ASSURANCE

Not applicable

Not applicable

Not applicable


-

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Section A4.2( d)/01



3.2.2 Detector

3.2.3 Standard( s)

3.2.4 Interfering substance(s)

3.3 Linea1ity

3.3. 1 Calibration range

3.3.2 Nmuber of measmements

3.3.3 Linearity

3.4 Specificity: intel'fel'ing substances



-

-•

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3.5 Recove1·y rntes at different levels



3.7 Precision

3.7.l Repeatability


CAR Doc III A4


XS

•

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Section A4.2( d)/01


4.1 Matel'ials and methods

4.2 Conclusion

4 .2 . l Reliability

4.2 .2 Deficiencies

Date

Matel'ials and methods


CAR Doc IIIA4


4. APPLICANT 'S SUMMARY AND CONCLUSION


This method is suitable for use by regulatory agencies to detect X6 pyrithione in blood plasma and in principle may be adapted for analysis in other body fluids and tissues. Stable label is used as the internal standard; however, the actual analyte a.ft.er derivatization is the uncomplexed pyrithione molecule, which is the form that both -•••••••••••• takes in biological fluids. The method is therefore applicable to copper pyrithione as well. The instnunenta.tion required to perfo1m the analysis is available in most well equipped analytical laboratories.

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Reliability

Ac.ceptability

Remai-ks



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Section A4.2( d)/02


Detailed justification:

Date

Evaluation of applicant 's justification

Conclusion

Rema1·ks


Determination of residues in animal and human body fluids and tissues

Final CAR Doc IIIA4

JUSTIFICATION FOR NON-SUBMISSION OF DATA Official use only

XI


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RMS: Sweden

Copper pyrithione

August 2013

CAR

Doc III A4

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Section A4.3/01

Annex Point IIIA, IV.1.

Detailed justification:

Date

Evaluation of applicant's justification

Conc.lusion

Rema1·ks


Determination of residues in/on food or feedstuffs

Final CAR DocIIIA4

JUSTIFICATION FOR NON-SUBMISSION OF DATA Official use only


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Section A4.3/01


1.1 Reference

1.2

1.2.1

1.2.2

1.2.3

2.1

2.2

2.3

3.1

3.1.l

3.1.2

3.2

3.2.l

Data protection

Data ovmer


Criteria for data

protection

Guideline study

GLP

Deviations

Preliminary

treatment

Enriclunent

Cleanup

Detection

Separation method

3.2.2 Detector


CAR Doc III A4


Environmental Media - Residues in Fish and Shellfish

1 REFERENCE

••• (2009) Method for the Analysis of Pyrithione in Fish Muscle by HPLC with MS/MS Detection, Arch Chemicals, Inc. Cheshire, CT, Report No. CASR-02-2008 (unpublished) .


Not applicable

Not applicable

Not applicable


--

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3.2.3 Standard(s)


3.3 Linea1·ity


3.3.2 Number of

measlll'ements

3.3.3 Linearity

3.4 Specificity:

intel'fering substances

3.5 Recovel'y rates at differ ent levels

3.5.1 Relative standard

deviation

3.6 Limit of

determination

3.7 Pl'ecision

3.7.1 Repeatability





•

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4.2 Conclusion

4.2. l Reliability

4.2.2 Deficiencies

Date





4 APPLICANT'S SUMMARY AND CONCLUSION

The method is accuarate and specific for pyrithione in fish at

concentrations equivalent to 0.5 to 5 ng/Kg of either copper or •

I None



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Section A4.3/01


Condusion

Reliability

Ac.ceptability

Rema I' ks




-

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Arch Chemicals Inc.

RMS: Sweden

Copper pyrithione

August 2013

CAR

Doc III A4

48 (49)

Reference list of studies submitted by Section No.

See document I

Arch Chemicals Inc.

RMS: Sweden

Copper pyrithione

September 2014

Final CAR

Doc III A4

49 (49)

Reference list of studies submitted by Author

See document I

Documents

Copper pyrithione - Europadissemination.echa.europa.eu/Biocides/ActiveSubstances/... · 2016-02-10 · Coppel' pyrithione Septembel' 2014 Final CAR Doc IIIA4 Determination of the