Registration Dossier

Administrative data

Description of key information

One experimental study is available for the skin sensitisation endpoint for the test substance. This study is compliant under Annex V on EU method B.6 (skin sensitisation) guidelines.

According to the results of this study, the test substance did not meet the GHS criteria. Therefore, it should be considered as not sensitising for the skin.

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:
key study
Reliability:
2 (reliable with restrictions)
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
The skin sensitisation in-vivo (non-LLNA) experimental study reported in this section should be considered as acceptable since it was performed before the LLNA skin sensitisation method was considered to be the preferred one for new in-vivo testings.

Moreover and according to ECHA guidance R.7a, page 234, existing data of good quality derived from tests such as the Buehler test are acceptable and, if they provide clear results, will preclude the need for further in vivo testing.
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100%
Adequacy of induction:
other: Information on adequacy of induction not available
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100%
Adequacy of challenge:
other: Information on adequacy of challenge not available
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 10
Positive control substance(s):
not specified
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10

Maximum concentration not causing irritating effects in preliminary test: 50%

Signs of irritation during induction:

Signs of irritation during induction were not scored during this test.

Evidence of sensitisation of each challenge concentration: None

Interpretation of results:
GHS criteria not met
Conclusions:
Not classified.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

GLP compliance: YES

Type of study: Buehler test

Justification for classification or non-classification

One experimental study is available for the skin sensitisation endpoint for the test substance. This study is compliant under Annex V on EU method B.6 (skin sensitisation) guidelines.

According to the results of this study, the test substance did not meet the GHS criteria. Therefore, it should be considered as not sensitising for the skin.