Registration Dossier
Registration Dossier
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EC number: 256-233-5 | CAS number: 45320-65-8
Endpoint summary
Administrative data
Description of key information
There is no evidence for a skin sensitising potential of N, N’-[(methylimino)bis (trimethylene)]bis(oleamide) from information of related read-across substance N,N’[(methylimino)bis(trimethylene)]bis(stearamide).
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
Refer to attached document - Reason / purpose for cross-reference:
- read-across source
- Key result
- Parameter:
- SI
- Value:
- 0.64
- Test group / Remarks:
- 5 % Test group
- Key result
- Parameter:
- SI
- Value:
- 1.12
- Test group / Remarks:
- 10 % Test group
- Key result
- Parameter:
- SI
- Value:
- 1.21
- Test group / Remarks:
- 25 % Test group
- Key result
- Parameter:
- EC3
- Remarks on result:
- not determinable
- Remarks:
- The EC3 value could not be calculated, since all S.I.´s are below the threshold value of 3.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Available data from a local lymph node assay according to OECD guideline 429 (2010) with the test substance N,N’[(methylimino)bis(trimethylene)]bis(stearamide) were used to evaluate the skin sensitization potency of N, N’-[(methylimino)bis(trimethylene)] bis(oleamide). Based on this read-across information it can be concluded, that N, N’-[(methylimino)bis (trimethylene)]bis(oleamide) is not a dermal sensitizer.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Available data from a local lymph node assay according to OECD guideline 429 (2010) with the test substance N,N’[(methylimino)bis(trimethylene)]bis(stearamide) were used to evaluate the skin sensitization potency of N, N’-[(methylimino)bis(trimethylene)] bis(oleamide).
Based on this read-across information it can be concluded, that N, N’-[(methylimino)bis (trimethylene)]bis(oleamide) is not a dermal sensitizer.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on read-across data from a study according to OECD Guideline 429 on the read-across substance N,N’[(methylimino)bis(trimethylene)]bis(stearamide),
N, N’-[(methylimino)bis (trimethylene)]bis(oleamide) does not need to be classified as skin sensitizer according the criteria of CLP, EU GHS (Regulation (EC) No 1272/2008).
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.
