Registration Dossier
Registration Dossier
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EC number: 251-846-4 | CAS number: 34140-91-5
Endpoint summary
Administrative data
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Effects on fertility
Description of key information
In accordance with Annex VIII of REACH, Column 2, a screening for reproductive/developmental toxicity does not need to be conducted as a testing proposal has been submitted for a pre-natal developmental toxicity study.
No adverse effects on reproductive organs were identified during repeated-dose toxicity testing conducted on the registered substance and its analogues from the primary alkylamines category. No information was identified on the registered substance and these analogues trigerring the need for a Extended One-Generation Reproductive Toxicity Study as per Annex IX of REACH.
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
A testing proposal is submitted to conduct a pre-natal developmental toxicity study on the registered substance in accordance with Annex IX, section 8.7.2, of REACH. The study shall be conducted via the oral route as it was identified as the most relevant route of exposure.
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study planned
- Justification for type of information:
- CONSIDERATIONS OF ALTERNATIVE METHODS ON TESTING PROPOSALS IN YOUR REGISTRATION
Public substance name: Oleic acid, compound with (Z)-N-octadec-9-enylpropane-1,3-diamine (2:1)
EC Number: 251-846-4
CAS Number: 34140-91-5
Date of considerations: 14 January 2022
Hazard endpoint for which vertebrate testing was proposed:
Reproductive toxicity (oral pre-natal developmental toxicity in rats, OECD TG no. 414) with the registered substance;
Considerations that the general adaptation possibilities of Annex XI of the REACH Regulation were not adequate to generate the necessary information
• available GLP studies: None.
• available non-GLP studies: None.
• historical human data: None.
• (Q)SAR
According to ECHA guidance R.7a (July 2017, page 495), QSAR approaches are currently not well fitted-for-purpose for reproductive toxicity and not all necessary aspects can be covered by a QSAR prediction.
• in vitro methods
In vitro reproduction studies are not available on the test substance.
Some in vitro test methods have been developed, however, according to Chapter R.7a (July 2017, page 495), the regulatory acceptance of these in vitro methods has not been achieved as they do not provide equivalent information.
• weight of evidence: No data is available which allow a weight of evidence approach.
• grouping and read-across: Data is available on two substances (Z)-N-9-octadecenylpropane-1,3-diamine (CAS 7173-62-8 / EC 230-528-9) and N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine (CAS 2372-82-9 / EC 219-145-8) identified as potential analogues, but there is no information available on the developmental toxicity of the registered substance and these two compounds, allowing to confirm these are suitable analogues for the endpoint of interest.
• substance-tailored exposure driven testing [if applicable]: Not applicable
• [approaches in addition to above [if applicable] : Not applicable
• other reasons [if applicable] :None
Considerations that the specific adaptation possibilities of Annexes VI to X (and column 2 thereof) were not applicable:
Test proposal is fully compliant with ECHA guidance R.7.a (July 2017, page 486). No specific adaptation possibilities of Annexes VI to X (and column 2 thereof) are applicable. - Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- 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.
