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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Qualifier:
no guideline followed
Principles of method if other than guideline:
Guinea pig maximisation test was conducted in male Hartley guinea pigs.
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
None stated
Species:
guinea pig
Strain:
Hartley
Sex:
male
Key result
Remarks on result:
no indication of skin sensitisation

No evidence of skin sensitisation.

Interpretation of results:
not sensitising
Conclusions:
The test substance showed no evidence of skin sensitization in male Hartley guinea pigs.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The test substance showed no evidence of skin sensitisation in male Hartley guinea pigs.

Justification for classification or non-classification

Skin sensitisation: Animal study give negative result

Therefore in accordance with Regulation (EC) No. 1272/2008 (as amended by Regulation (EC) No. 286/2011) Table 3.4.2, this substance should not be classified as skin sensitiser.