Registration Dossier

Administrative data

Description of key information

No evidence of skin sensitisation has been reported for similar substances.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
LLNA study not available and the lead registrant for EC 290-476-8 considered it appropriate to read-across to another similar substance.
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
GHS criteria not met
Conclusions:
No evidence of sensitisation observed.
Executive summary:

No evidence of sensitisation observed. Even when considering the absence of key data in the published report, the conclusions made at the time by those undertaking the review are that the substance can be used in dermally applied cosmetic products. Human monitoring is also reported and no evidence of sensitising effects is reported.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Justification for type of information:
See read-across justification attached in Section 13.
Reason / purpose:
read-across source
Remarks on result:
no indication of skin sensitisation
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Evidence from testing of similar materials indicates that the registered substance does not require classification for skin sensitisation under the terms of Regulation (EC) No. 1272/2008.