Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to guideline
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:
other: guinea pig maximization 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 chemical
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.