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Administrative data

Description of key information

Study conducted to recognised testing guidelines with GLP certification.

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)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
not specified
GLP compliance:
yes
Type of study:
other: Not specified - from "429-04-0_endpoints_PV512082-22" provided by ECHA
Justification for non-LLNA method:
From "429-04-0_endpoints_PV512082-22" provided by ECHA
Species:
guinea pig
Strain:
Dunkin-Hartley
Route:
intradermal
Vehicle:
other: at 2.5% in cottonseed oil and in FCA.
Concentration / amount:
0.1 mL/injection site of test material
Route:
intradermal
Concentration / amount:
In booster. 0.3 mL/patch of test material at 25% in acetone.
Concentration of test material and vehicle used for each challenge:
0.2 mL/patch of test material at 25% in acetone
No. of animals per dose:
Number of animals in test group: 20
Number of animals in negative control group: 20
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
25%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
25%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
rechallenge
Hours after challenge:
24
Group:
test group
Dose level:
25%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
rechallenge
Hours after challenge:
48
Group:
test group
Dose level:
25%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Justification for classification or non-classification