Registration Dossier

Administrative data

Description of key information

Short description of key information:
Sensitization: moderate. Not sensitising according to Regulation (EC) no 1272/2008 (CLP).

Justification for selection of skin sensitisation endpoint:
Only one study available.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation, other
Remarks:
The study is non-LLNA as it is the only study already available based on literature already published.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1975-1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Due to absence of information on number of animal reliability category according to Klimisch is 3 (red score). Evaluator proposal is 2 (“reliable with restrictions”) because number of animals in compliance with method can be various.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to
Guideline:
other: maximization test described by magnusson and Kligman
GLP compliance:
no
Remarks:
The study was conducted in 1975 whereas OECD and EU Guidelines as well as GLP Principles were implemented in 1981 and 1988
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The study is non-LLNA as it is the only study already available based on literature already published.
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Key result
Group:
test group
No. with + reactions:
4
Total no. in group:
10
Remarks on result:
other: Response: 40%, Sensitization: moderate

Bunber responding: 4/10

Response: 40%

Sensitization: moderate

Interpretation of results:
GHS criteria not met
Conclusions:
Not sensitising according to Regulation (EC) no 1272/2008 (CLP).
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Link to relevant study records
Reference
Endpoint:
respiratory sensitisation
Data waiving:
other justification
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Justification for selection of respiratory sensitisation endpoint:
Additional testing not required.

Justification for classification or non-classification

The substance does not meet the criteria for classification as sensitizing.