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
According to Annex VIII, a fertility study is required for compounds with an average tonnage band > 10t/a. However, the study can be waived because a pre-natal developmental toxicity study is currently in preparation based on the ECHA Decision on testing proposal (Decision number TPE-D-2114526738-39-01/F). When the OECD 414 study is finalized, the information will be used to fill data requirements of this endpoint.
No reproductive toxicity effect is known for benzylated diethylenetriamine and triethylenetetramine. Once the results of the 90-day repeated dose toxicity study and the pre-natal developmental toxicity study are available (both studies are currently in preparation), this toxicological endpoint will be re-evaluated.
Link to relevant study records
- 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:
- the extended one-generation reproductive toxicity study does not need to be conducted because there are no results from available repeated dose toxicity studies that indicate adverse effects on reproductive organs or tissues, or reveal other concerns in relation with reproductive toxicity
- Endpoint:
- screening for reproductive / developmental toxicity
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Referenceopen allclose all
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available (further information necessary)
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
According to Annex IX a study for the endpoint developmental toxicity is required. An oral OECD 414 study with rats for the test material is proposed.
Link to relevant study records
- Endpoint:
- developmental toxicity
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Justification for type of information:
- According to the Decision on testing proposal (Decision number TPE-D-2114526738-39-01/F) from 20 October 2020, the prenatal developmental toxicity study has been commissioned and is currently ongoing.
The REACH dossier will be updated without undue delay once the study is finalized. The proposed study completion date is in September 2023 according to the study plan. - Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Species:
- rat
Reference
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
Justification for classification or non-classification
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.
