Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: only secondary literature (handbook)
Qualifier:
no guideline followed
Principles of method if other than guideline:
Sensitization test according to Maguire (modified)
GLP compliance:
not specified
Type of study:
other: Maguire method
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Vehicle:
no data
Concentration / amount:
undiluted
Vehicle:
no data
Concentration / amount:
undiluted
No. of animals per dose:
10 animals
Positive control substance(s):
yes
Remarks:
Positive control group
Positive control results:
All 10 animals showed sensitizing effects

When a group of 10 animals was tested with undiluted test substance none was sensitized (whereas all 10 of positive control group were sensitized).

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the present study the test item is not a skin sensitiser.
Executive summary:

The skin sensitizing potential of the test item was determined. A group of 10 guinea pigs was tested with undiluted test substance. No sensitizing effects were observed. All 10 animals in the positive group showed sensitizing effects.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The skin sensitizing potential of the test item was determined. A group of 10 guinea pigs was tested with undiluted test substance. No sensitizing effects were observed. All 10 animals in the positive group showed sensitizing effects.


Migrated from Short description of key information:
The skin sensitizing potential of the test item was determined on guinea pigs according to the Maguire method. No sensitizing potential was determined.

Justification for selection of skin sensitisation endpoint:
Only study available

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Self-Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data is reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on the results the substance is not considered to be classified as skin sensitizing under Regulation (EC) No 1272/2008.