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Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Study included as a supporting study to support Classification and Labelling and is not considered as reliable for REACH purposes as the full experimental report is not available. This method differs to the standard guinea pig maximisation tests and Buehler assay (although is most similar to the Buehler assay) in use at the time in terms of some aspects of the methodology, and little detail is available on the experimental conditions (animal numbers/status, guideline etc.). The induction doses used also appeared to cause corrosion based on the effects observed where standard tests require that this should only cause mild-irritation. The challenge dose should also cause no irritation rather than ‘minimal irritation’ which is not further specified.

Data source

Reference
Reference Type:
review article or handbook
Title:
1,4-Naphthoquinone - BUA Report 211 (October 1998)
Author:
GDCh-Advisory Committee on Existing Chemicals (BUA)
Year:
1998
Bibliographic source:
S.Hirzel Verlag Stuttgart; Wissenschaftliche Verlags-Gesellschaft Stuttgart, 2000 , ISBN3-7776-1064-X

Materials and methods

Test guideline
Qualifier:
no guideline followed
GLP compliance:
not specified
Type of study:
not specified
Justification for non-LLNA method:
Conducted test pre-dates the LLNA and in vitro/chemico skin sensitisation tests.

Test material

Constituent 1
Chemical structure
Reference substance name:
1,4-naphthoquinone
EC Number:
204-977-6
EC Name:
1,4-naphthoquinone
Cas Number:
130-15-4
Molecular formula:
C10H6O2
IUPAC Name:
1,4-naphthoquinone
Test material form:
solid
Specific details on test material used for the study:
No details on test substance purity

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified

Study design: in vivo (non-LLNA)

No. of animals per dose:
Not specified
Details on study design:
The repeated painting of guinea pig skin over an 11-day period with 0.1, 0.5 and 1 % solutions of 1,4 -naphthoquinone in ether on days 1 to 2, 3 to 4 and 6 to 11, respectively, caused reddening of the skin at the beginning of the treatment with subsequent brown-black scab formation. After the local effects had healed up (by day 21) a 0.1 % solution (which had been shown to cause only minimal irritation after a single application) was applied on day 23 to part of the skin that had not previously been treated.
Positive control substance(s):
not specified

Results and discussion

Positive control results:
Not specified

In vivo (non-LLNA)

Results
Remarks on result:
positive indication of skin sensitisation

Any other information on results incl. tables

The repeat application of the 0.1% solution to the guinea pig skin after the local effects had abated (Day 23) led to local allergic reactions of the skin (reddening, oedema and nodule formation) in all of the animals, which diminished after 24 hours with mild peeling. Based on these effects the substance was considered to have the potential to be a skin sensitiser.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
The test substance assessed in a non-standard guinea pig painting study provided an indication that the substance would be a skin sensitiser although there were limitations in the methodology used as well as a lack of access to the source data.