Oleic acid, compound with (Z)-N-octadec-9-enylpropane-1,3-diamine (2:1)

Developmental toxicity / teratogenicity

Administrative data

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.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 414 (Prenatal Developmental Toxicity Study)

Deviations:

no

Test material

Test material information

Constituent 1

Reference substance name:

Oleic acid, compound with (Z)-N-octadec-9-enylpropane-1,3-diamine (2:1)

EC Number:

251-846-4

EC Name:

Oleic acid, compound with (Z)-N-octadec-9-enylpropane-1,3-diamine (2:1)

Cas Number:

34140-91-5

Molecular formula:

C21H44N2.2C18H34O2

IUPAC Name:

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

Species:

rat