Registration Dossier
Registration Dossier
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EC number: 204-661-8 | CAS number: 123-91-1
Toxicity to reproduction
Administrative data
- Endpoint:
- extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- According to REACH Annex XI Section 1.2 data from studies other than required according to Annex IX and/or Annex X for a specific endpoint may be used to sufficiently conclude on this endpoint by an weight of evidence (WoE) assessment and taking into account the overall picture of all data sources available.
There are comprehensive data available with the registered substance investigating repeated dose toxicity under sub-chronic as well as chronic exposure conditions via the oral and inhalation route in two different species (rats and mice). None of these studies revealed a test item related impairment of the reproductive organs in either sex or species. Thus, there are no indications that fertility functions could be affected by the test item below maternal toxic concentrations.
Furthermore, a prenatal-developmental toxicity study in the rat is available with the registered substance. Results demonstrate that there is no concern in regards to developmantal toxicity / teratogenicity with the test item.
It should be noted that the registered substance has to be classified for carcinogenicity (cat. 1B) according to CLP and appropriate risk management measures are implemented. This legally binding classification makes further testing for toxicity to reproduction obsolete, also considering animal welfare reasons.
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
