EU RISK ASSESSMENT

eu risk assessment - [Diantimony trioxide] cas [1309-64-4]

title

European Union Risk Assessment Report

DiAntimony Trioxide

CAS No: 1309-64-4

EINECS No: 215-175-0

Risk Assessment

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Printed in Italy

DiAntimony Trioxide

CAS No: 1309-64-4

EINECS No: 215-175-0

Risk Assessment

May 2008

Sweden

Rapporteur for the risk assessment of DIANTIMONY TRIOXIDE is the Swedish Chemicals Agency.

Contact point:

Swedish Chemicals Inspectorate

Box 2

S-172 67 Sundbyberg

SWEDEN

E-mail: kemi@kemi.se

Phone +46 8 519 41 100

FAX + 46 8 735 76 98

Date of Last Literature Search :

2007

Review of report by MS Technical Experts finalised:

May 2008

Final report:

2008

Foreword

This Draft Risk assessment Report is carried out in accordance with Council Regulation (EEC) 793/93 on the evaluation and control of the risks of existing substances. Existing substances are chemical substances in use within the European Community before September 1981 and listed in the European Inventory of Existing Commercial Chemical Substances. Regulation 793/93 provides a systematic framework for the evaluation of the risks to human health and the environment of these substances if they are produced or imported into the Community in volumes above 10 tonnes per year.

There are four overall stages in the Regulation for reducing the risks: data collection, priority setting, risk assessment and risk reduction. Data provided by Industry are used by Member States and the Commission services to determine the priority of the substances, which need to be assessed. For each substance on a priority list, a Member State volunteers to act as Rapporteur, undertaking the in-depth Risk Assessment and recommending a strategy to limit the risks of exposure to the substance, if necessary.

The methods for carrying out an in-depth Risk Assessment at Community level are laid down in Commission Regulation (EC) 1488/94, which is supported by a technical guidance document. Normally, the Rapporteur and individual companies producing, importing and/or using the chemicals work closely together to develop a draft Risk Assessment Report, which is then presented at a Meeting of Member State technical experts for endorsement. The Risk Assessment Report is then peer-reviewed by the Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE), which gives its opinion to the European Commission on the quality of the risk assessment.

This Draft Risk Assessment Report is currently under discussion in the Competent Group of Member State experts with the aim of reaching consensus. During the course of these discussions, the scientific interpretation of the underlying scientific information may change, more information may be included and even the conclusions reached in this draft may change. The Competent Group of Member State experts seek as wide a distribution of these drafts as possible, in order to assure as complete and accurate an information basis as possible. The information contained in this Draft Risk Assessment Report does not, therefore, necessarily provide a sufficient basis for decision-making regarding the hazards, exposures or the risks associated with the priority substance.

This Draft Risk Assessment Report is the responsibility of the Member State rapporteur. In order to avoid possible misinterpretations or misuse of the findings in this draft, anyone wishing to cite or quote this report is advised to contact the Member State rapporteur beforehand.

Contact Details of the Rapporteur(s)

overall results of the risk assessment

CAS Number:

1309-64-4

EINECS Number:

215-175-0

IUPAC Name:

Diantimony trioxide

Environment

Aquatic compartment

Surface water

Conclusion (ii)There is at present no need for further information and/or testing and no need for risk reduction measures beyond those which are being applied already.

This conclusion applies to all scenarios.

Sediment

Conclusion (iii)There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account.

This conclusion applies to the generic scenarios for formulation and application of flameretardant textile back-coating and to one production site (site P1).

Conclusion (ii)There is at present no need for further information and/or testing and no need for risk reduction measures beyond those which are being applied already.

This conclusion applies to all other scenarios, including nineteen sites using diantimony trioxide in textile applications and three production sites, that all report releases.

Waste water treatment plants

Conclusion (ii)There is at present no need for further information and/or testing and no need for risk reduction measures beyond those which are being applied already.

This conclusion applies to all scenarios.

Terrestrial compartment

Conclusion (ii)There is at present no need for further information and/or testing and no need for risk reduction measures beyond those which are being applied already.

This conclusion applies to all scenarios.

Atmosphere

Conclusion (ii)There is at present no need for further information and/or testing and no need for risk reduction measures beyond those which are being applied already.

This conclusion applies to all scenarios.

Secondary poisoning

Conclusion (ii)There is at present no need for further information and/or testing and no need for risk reduction measures beyond those which are being applied already.

This conclusion applies to all scenarios.

Marine compartment

PBT-assessment

There is currently no agreed approach to perform a PBT-assessment of a metal, therefore a PBT-assessment will not be performed.

Marine water

Conclusion (ii)There is at present no need for further information and/or testing and no need for risk reduction measures beyond those which are being applied already.

This conclusion applies to all scenarios.

Despite having RCR >1 conclusion iii) is not drawn for application of flame-retardant back-coating. The reason for this is that, according to information from IAOIA, none of the sites covered by the survey IAOIA performed to collect exposure data from all their customers is located by the sea. However, it has to be pointed out that the coverage of this survey regarding textile backcoating sites was rather low. Therefore, it cannot be ruled out that textile backcoating sites located at the sea having emissions to the marine environment may exist.

Marine sediment

Conclusion (ii)There is at present no need for further information and/or testing and no need for risk reduction measures beyond those which are being applied already.

This conclusion applies to all scenarios.

Despite having RCR >1 conclusion iii) is not drawn for formulation and application of flame-retardant back-coating. The reason for this is that, according to information from IAOIA, none of the sites covered by the survey IAOIA performed to collect exposure data from all their customers is located by the sea. For the formulation of flame-retardant in textiles, the coverage of this survey is high and there is a high probability that for this use area the marine scenario may not be relevant. For application of textile back-coating on the other hand the coverage of the survey is lower and it cannot be ruled out that sites located at the sea having emissions to the marine environment may exist.

Secondary poisoning in the marine environment

Conclusion (ii)There is at present no need for further information and/or testing and no need for risk reduction measures beyond those which are being applied already.

This conclusion applies to all scenarios.

Human health

Human health (toxicity)

Workers

Conclusion (iii)There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account.

Conclusion (iii) applies to skin irritation for all scenarios to indicate the need for classification. Once classified the conclusion (iii) will be changed to conclusion (ii).

Conclusion (iii) also applies to repeated dose toxicity (local pulmonary toxicity after inhalation) and carcinogenicity (pulmonary carcinogenicity) for the following scenarios: Production of Diantimony Trioxide: Conversion, Refuming and Final handling with and without RPE, Use as a catalyst in production of PET: Powder handling, Use as flame-retardant in production of plastics: Raw material handling, Use as flame-retardant in treated textiles: Formulation, Use in pigments, paints, coatings and ceramics: Loading and mixing, Use as flame-retardant in production of rubber: Formulation and Processing.

Conclusion (ii)There is at present no