Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
There are no reproductive toxicity studies available for Step2 catalyst. According to Annex XI, 3.1 “testing in accordance with Sections 8.6 and 8.7 of Annex VIII and in accordance with Annex IX and Annex X” was omitted, because, according to Annex XI, 3.2 b) “the manufacturer or importer demonstrates and documents for all relevant scenarios that throughout the life cycle strictly controlled conditions as set out in Article 18(4) (a) to (f) apply”.
The respective documentation is available in detailed on-site documentation and summarised in the Chemical safety report.
Link to relevant study records
- Endpoint:
- extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
- Data waiving:
- exposure considerations
- Justification for data waiving:
- the study does not need to be conducted because relevant human exposure can be excluded as demonstrated in the relevant exposure assessment
- Species:
- mouse
Reference
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
Effects on developmental toxicity
Description of key information
There are no developmental toxicity studies available for Step2 catalyst. According to Annex XI, 3.1 “testing in accordance with Sections 8.6 and 8.7 of Annex VIII and in accordance with Annex IX and Annex X” was omitted, because, according to Annex XI, 3.2 b) “the manufacturer or importer demonstrates and documents for all relevant scenarios that throughout the life cycle strictly controlled conditions as set out in Article 18(4) (a) to (f) apply”.
The respective documentation is available in detailed on-site documentation and summarised in the Chemical safety report.
Link to relevant study records
- Endpoint:
- developmental toxicity
- Data waiving:
- exposure considerations
- Justification for data waiving:
- the study does not need to be conducted because relevant human exposure can be excluded as demonstrated in the relevant exposure assessment
- Species:
- rat
Reference
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
Justification for classification or non-classification
Step 2 catalyst is not classified for reproductive or developmental toxicity due to the lack of data.
According to Annex XI, 3.1 “testing in accordance with Sections 8.6 and 8.7 of Annex VIII and in accordance with Annex IX and Annex X” was omitted, because, according to Annex XI, 3.2 b) “the manufacturer or importer demonstrates and documents for all relevant scenarios that throughout the life cycle strictly controlled conditions as set out in Article 18(4) (a) to (f) apply”.
The respective documentation is available in detailed on-site documentation and summarised in the Chemical safety report.
Additional information
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.
