Registration Dossier

Administrative data

Description of key information

Skin sensitisation

Based on the result obtained from the studies available for the chemical, it can be concluded that the test chemical cannot cause skin sensitization and thus cannot be considered as skin sensitizing.

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:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from secondary source.
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Skin sensitization test was carried out to study the sensitization potential in the given test chemical.
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
not specified
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
not specified
Route:
other: not specified
Vehicle:
other: not specified
Concentration / amount:
not specified
Day(s)/duration:
not specified
Adequacy of induction:
not specified
Route:
other: not specified
Vehicle:
not specified
Concentration / amount:
not specified
Day(s)/duration:
not specified
Adequacy of challenge:
not specified
No. of animals per dose:
not specified
Details on study design:
not specified
Challenge controls:
not specified
Positive control substance(s):
not specified
Positive control results:
not specified
Reading:
1st reading
Group:
test chemical
Dose level:
2%
No. with + reactions:
0
Clinical observations:
Allergic contact dermatitis did not developed.not sensitizing
Remarks on result:
no indication of skin sensitisation

Other Details not known

Interpretation of results:
other: not sensitising
Conclusions:
The given test chemical is not sensitizing to the skin of guinea pig.
Executive summary:

Skin sensitization study was conducted for the given test chemical. A test for sensitization revealed that allergic contact dermatitis did not develop. A 2% solution was not irritating to the skin of guinea pig. It can be concluded that the test chemical is not sensitizing.

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

Skin sensitization

In different studies, the given test chemical has been investigated for the skin sensitization potential to a greater or lesser extent. The studies are based on in-vivo experiments conducted in rodents which have been summarized as below -

 

Skin sensitization study was conducted for the given test chemical. A test for sensitization revealed that allergic contact dermatitis did not develop. A 2% solution was not irritating to the skin of guinea pig. It can be concluded that the test chemical is not sensitizing.

 

The above study is supported with maximization test performed to evaluate the allergic effect of test chemical in Guinea pig. For induction exposure, 0.1 mL intradermal injections of test material in olive oil given to Guinea pig. 7 days after injection, the interscapular region was again shaved, and treated with w (SLS) =10 %. 8 days later, 0.2 mL of test agent preparation was occlusively patched on the same region for 48 h. 21 days after the initial intradermal injection, all animals were challenged by 0.1 mL test chemical in olive oil was applied to the shaved areas of the guinea pigs by closed patch test method, and left for 24 h. Reactions were read 24 h and 48 h after removing the patches. No or 0% allergic reaction was observed after test. Therefore, the substance is considered to be non-sensitizing to Guinea Pig.

 

Based on the result obtained from the studies available for the chemical, it can be concluded that the test chemical cannot cause skin sensitization and thus cannot be considered as skin sensitizing.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the result obtained from the studies available for the chemical, it can be concluded that the test chemical cannot cause skin sensitization and thus cannot be considered as skin sensitizing.