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Key value for chemical safety assessment

Effects on fertility

Description of key information

Waiving of the fertility study due to classification regarding carcinogenicity (Carc. 1B, H350) and mutagenicity (Cat.2, H341) according to REACH legal text Annex VIII: "Standard information requirements for substances manufactured or imported in quantities of 10 tonnes or more", Column 2.

Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

1,3-propanesultone has been found to be carcinogenic in rats and mice by any of several routes of administration (i.e. oral, dermal, subcutaneous, i.v., transplacental). Based on the available data regarding carcinogenicity 1,3-propanesultone is subject to classification and labelling: Carc. 1B, H350 according to Regulation 1272/2008/EC. Additionally, a high potential for genetic toxicity of the test item was indicated in in vitro and in vivo test systems (e.g. Ames test, chromosomal aberration test, micronucleus test) - see chapter Genetic toxicity - and therefore the substance is subject for classification and labelling according to Regulation 1272/2008/EC (Cat. 2, H341) regarding mutagenicity. According to the REACH legal text Annex VIII: "Standard information requirements for substances manufactured or imported in quantities of 10 tonnes or more", studies on the toxicity of reproduction do not need to be conducted if the substance is known to be a genotoxic carcinogen and / or a germ cell mutagen and appropriate risk management measures are implemented, as is the case for 1,3-propanesultone. Therefore, a study on fertility does not need to be performed.

Effects on developmental toxicity

Description of key information
Waiving of the developmental toxicity study due to classification regarding carcinogenicity (Carc. 1B, H350) and mutagenicity (Cat.2, H341) according to REACH legal text Annex VIII: "Standard information requirements for substances manufactured or imported in quantities of 10 tonnes or more", Column 2. 
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

1,3-propanesultone has been found to be carcinogenic in rats and mice by any of several routes of administration (i.e. oral, dermal, subcutaneous, i.v., transplacental) - see chapter Carcinogenicity. Based on the available data regarding carcinogenicity 1,3-propanesultone is subject to classification and labelling: Carc. 1B, H350 according to Regulation 1272/2008/EC. Additionally, a high potential for genetic toxicity of the test item was indicated in in vitro and in vivo test systems (e.g. Ames test, chromosomal aberration test, micronucleus test) - see chapter Genetic toxicity - and therefore the substance is subject for classification and labelling according to Regulation 1272/2008/EC (Cat. 2, H341) regarding mutagenicity. According to the REACH legal text Annex VIII: "Standard information requirements for substances manufactured or imported in quantities of 10 tonnes or more", studies on the toxicity of reproduction do not need to be conducted if the substance is known to be a genotoxic carcinogen and / or a germ cell mutagen and appropriate risk management measures are implemented, as is the case for 1,3-propanesultone. Therefore, a study on developmental toxicity does not need to be performed.

Justification for classification or non-classification

No data available regarding reproductive toxicity.