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Diss Factsheets

Administrative data

Description of key information

In a Guinea pig skin sensitization test the test item was found to be not a skin sensitizer.

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:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
not applicable
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Exisitng in vivo study available (1974)
Species:
guinea pig
Strain:
not specified
Sex:
male/female
Route:
intradermal
Vehicle:
other: 6% acetone/saline
Concentration / amount:
0.1875%
No.:
#1
Route:
intradermal
Vehicle:
other: 6%acetone/ saline
Concentration / amount:
0.075%
No.:
#2
Route:
other: topical
Vehicle:
other: acetone
Concentration / amount:
20%
No. of animals per dose:
10
Details on study design:
Guinea pigs were treated to induce sensitization by intradermal injection, and were challenged approximately 2 weeks later by intradermal injection and topical application. As there was no evidence of sensitization the induction and challenge sequences were repeated.
Challenge controls:
no data
Positive control substance(s):
no
Positive control results:
no data
Key result
Reading:
1st reading
Group:
test chemical
Dose level:
induction 0.1875%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
rechallenge
Group:
test chemical
Dose level:
intradermal injection 0.075%/ topical application 20%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Group:
negative control
Remarks on result:
not measured/tested
Reading:
rechallenge
Group:
negative control
Remarks on result:
not measured/tested
Reading:
1st reading
Group:
positive control
Remarks on result:
not measured/tested
Reading:
rechallenge
Group:
positive control
Remarks on result:
not measured/tested
Interpretation of results:
GHS criteria not met
Conclusions:
No guinea pigs sensitized after 1 or 2 induction-treatments.
Executive summary:

A Guinea pig skin sensitization test was conducted with the test item.

10 Guinea pigs were treated to induce sensitization by intradermal injection, and were challenged approximately 2 weeks later by intradermal injection and topical application. As there was no evidence of sensitization the induction and challenge sequences were repeated.

After 2 sets of sensitizing injections no guinea pigs were sensitized.

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

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

A Guinea pig skin sensitization test was conducted with the test item.

10 Guinea pigs were treated to induce sensitization by intradermal injection, and were challenged approximately 2 weeks later by intradermal injection and topical application. As there was no evidence of sensitization the induction and challenge sequences were repeated.

After 2 sets of sensitizing injections no guinea pigs were sensitized.

Justification for classification or non-classification

Harmonized classification:

The registered substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.

Self-classification:

Based on the available data, the registered substance is not classified for skin sensitisation according to the Regulation (EC) No. 1272/2008 (CLP) and GHS.

No information was available regarding respiratory sensitisation.