Registration Dossier
Registration Dossier
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EC number: 208-796-3 | CAS number: 542-02-9
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
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
Screening study for reproductive/developmental toxicity :
According to column 2 of Annex VIII, section 8.7.1 of REACH regulation, testing on reproductive toxicity (screening for reproductive/developmental toxicity (OECD 421 or 422)), does not need to be conducted if a pre-natal development toxicity study is available. In compliance with Annex IX, section 8.7.2 a testing proposal for developmental toxicity is submitted within the dossier. Thus, conducting of a screening study for reproductive/developmental toxicity is not necessary.
Two generation study:
According to column 2 of Annex IX, section 8.7.3 of REACH regulation a decision on the need to perform a study at this tonnage level should be based on the outcome of all relevant available data. At present no relevant data are available and a study proposal is submitted within the dossier for a developmental toxicity study. If data from this study is available, the need to perform a two generation reproductive toxicity study at this tonnage level will be evaluated.
Short description of key information:
There is no data available on the reproductive toxicity of Acetoguanamine.
Effects on developmental toxicity
Description of key information
There is no data available for the developmental toxicity on Acetoguanamine.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available (further information necessary)
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
Testing proposal prenatal developmental toxicity:
According to Annex IX, section 8.7.2 of REACH Regulation a prenatal developmental toxicity study is required. Therefore study according to OECD 414 ("Prenatal Developmental Toxicity Study") with Acetogunamine is proposed.
Justification for classification or non-classification
There is no data available on reproductive toxicity with Acetoguanamine. Nevertheless there are no indications for a classification for reproductive toxicity at this time. Evaluation will be considered based on the outcome of the proposed developmental toxicity study.
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.
