Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

Trichloroethylene has harmonised at the EU level classifiecation in accordance with the CLP regulation and it is not classified for reproductive or developmental toxicity.

 

Column 2 criteria for reproduction toxicity testing of trichloroethylene provide the following adaptations:

The studies need not be conducted if:

         the substance is known to be a genotoxic carcinogen and appropriate risk management measures are implemented, or

         the substance is known to be a germ cell mutagen and appropriate risk management measures are implemented.

 

Trichloroethylene has harmonized at EU level classification and it is classified as Mutagenicity Category 3; R68 - Possible risk of irreversible effects, in accordance with Directive 67/548/EEC and Mutagenicity 2, Germ Cell Mutagenicity, Hazard Category 2, H341: Suspected of causing genetic defects, in accordance with the GHS criteria of Regulation (EC) No 1272/2008.

 

Trichloroethylene is also classified as Carcinogenicity Category 2: R45: May cause cancer, in accordance with Directive 67/548/EEC and Carcinogenicity, Hazard Category 1B, H350: May cause cancer, in accordance with the GHS criteria of Regulation (EC) No 1272/2008.

 

Therefore, no additional testing of trichloroethylene for reproductive/developmental toxicity is required.

 

Effects on developmental toxicity

Additional information

Trichloroethylene has harmonised at the EU level classifiecation in accordance with the CLP regulation and it is not classified for reproductive or developmental toxicity.

 

Column 2 criteria for reproduction toxicity testing of trichloroethylene provide the following adaptations:

The studies need not be conducted if:

         the substance is known to be a genotoxic carcinogen and appropriate risk management measures are implemented, or

         the substance is known to be a germ cell mutagen and appropriate risk management measures are implemented.

 

Trichloroethylene has harmonized at EU level classification and it is classified as Mutagenicity Category 3; R68 - Possible risk of irreversible effects, in accordance with Directive 67/548/EEC and Mutagenicity 2, Germ Cell Mutagenicity, Hazard Category 2, H341: Suspected of causing genetic defects, in accordance with the GHS criteria of Regulation (EC) No 1272/2008.

 

Trichloroethylene is also classified as Carcinogenicity Category 2: R45: May cause cancer, in accordance with Directive 67/548/EEC and Carcinogenicity, Hazard Category 1B, H350: May cause cancer, in accordance with the GHS criteria of Regulation (EC) No 1272/2008.

 

Therefore, no additional testing of trichloroethylene for reproductive/developmental toxicity is required.

 

Toxicity to reproduction: other studies

Additional information

Trichloroethylene has harmonised at the EU level classifiecation in accordance with the CLP regulation and it is not classified for reproductive or developmental toxicity.

 

Column 2 criteria for reproduction toxicity testing of trichloroethylene provide the following adaptations:

The studies need not be conducted if:

         the substance is known to be a genotoxic carcinogen and appropriate risk management measures are implemented, or

         the substance is known to be a germ cell mutagen and appropriate risk management measures are implemented.

 

Trichloroethylene has harmonized at EU level classification and it is classified as Mutagenicity Category 3; R68 - Possible risk of irreversible effects, in accordance with Directive 67/548/EEC and Mutagenicity 2, Germ Cell Mutagenicity, Hazard Category 2, H341: Suspected of causing genetic defects, in accordance with the GHS criteria of Regulation (EC) No 1272/2008.

 

Trichloroethylene is also classified as Carcinogenicity Category 2: R45: May cause cancer, in accordance with Directive 67/548/EEC and Carcinogenicity, Hazard Category 1B, H350: May cause cancer, in accordance with the GHS criteria of Regulation (EC) No 1272/2008.

 

Therefore, no additional testing of trichloroethylene for reproductive/developmental toxicity is required.

 

Justification for classification or non-classification