Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

developmental toxicity
Type of information:
experimental study planned
Justification for type of information:

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.

Data source

Materials and methods

Test guideline
according to guideline
OECD Guideline 414 (Prenatal Developmental Toxicity Study)

Test material

Constituent 1
Chemical structure
Reference substance name:
Oleic acid, compound with (Z)-N-octadec-9-enylpropane-1,3-diamine (2:1)
EC Number:
EC Name:
Oleic acid, compound with (Z)-N-octadec-9-enylpropane-1,3-diamine (2:1)
Cas Number:
Molecular formula:
oleic acid, compound with (Z)-N-octadec-9-enylpropane-1,3-diamine (2:1)
Test material form:
liquid: viscous
Details on test material:
Chemical registery number : CAS 34140-91-5 / EC 251-846-4
Chemical name : N-[(9Z)-octadec-9-en-1-yl]propane-1,3-diaminium di[(9Z)-octadec-9-enoate

Based on the qualitative and quantitative information on the composition, the sample used are representative of the boundary composition shared and agree by each registrant.

Test animals


Results and discussion

Applicant's summary and conclusion