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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
disregarded due to major methodological deficiencies
Study period:
1978
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Modified Draize procedure using 10 animals in test group instead of 20. Morevoer, some of the substances tested that were shown to be non-sensitizer under the study conditions are currently classified as skin sensitizer, so the test method is not considered to be reliable enough for the purpose of hazard assessment.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1978

Materials and methods

Principles of method if other than guideline:
Modified Draize Procedure
GLP compliance:
no
Remarks:
pre-GLP
Type of study:
other: modified draize procedure

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): Camphor white oil

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 350 g
- Housing: Animals were housed in pairs of same sex in wire mesh cages
- Diet: Pelleted guinea pig diet, cabbage and hay, ad libitum
- Water, ad libitum

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
no data
Concentration / amount:
- Injection challenge concentration (ICC): 0.15 %
- Application challenge concentration (ACC): 30 %
Challengeopen allclose all
Route:
other: intradermal and topical application, open
Vehicle:
no data
Concentration / amount:
- Injection challenge concentration (ICC): 0.15 %
- Application challenge concentration (ACC): 30 %
No. of animals per dose:
Total: 10 animals
Details on study design:
PRELIMINARY STUDY:
- Intradermal injection: Four animals of the same sex were injected intradermally on the shaved flanks with 0.1 mL aliquots of test substance. The reactions were examined for size (two largest diameters), erythema and oedema, 24 h later and the concentration giving slight but perceptible irritation with no oedema was selected as the injection challenge concentration (ICC).
- Topical application: Aliquots (0.1 mL) of a range of concentrations of test substance were applied in small circular areas to the shaved flanks of 4 guinea pigs of the same sex. The reactions were examined for erythema 24 h later and the highest concentration which caused no irritation was selected as the application challenge concentration (ACC).

MAIN STUDY

A. INDUCTION EXPOSURE: Intradermal
- No. of exposures: One
- Exposure period: 14 days
- Test groups: For each animal 0.1 mL aliquots of test substance at 2.5 times the ICC were injected intradermally at 4 sites which overlie the 2 auxiliary and 2 inguinal lymph nodes.
- Control group: Untreated
- Frequency of applications: One

B. CHALLENGE EXPOSURE: Intradermal and topical
- No. of exposures: One
- Day(s) of challenge: 14
- Exposure period: 24 h
- Test groups: Each animal was challenged intradermally in one flank and topically (uncovered) in the other with 0.1 mL aliquots of test substance at the respective ICC (0.15 %) and ACC (30 %).
- Control group: At each challenge with controls, 4 previously untreated animals of the same sex were treated intradermally and topically on opposite flanks with 0.1 mL aliquots of test substance at the ICC and ACC respectively.
- Evaluation (hr after challenge): 24 h

- Scoring: Reactions were examined under a Philips colour matching unit with fluorescent tubes. Each injection reaction was given a total score based on size (2 largest diameters), erythema and oedema. Individual reactions were considered positive when their total score was significantly greater than the average total score for control reactions. Application reactions were scored on a 0 to +++scale and individual reactions were considered positive if (a) they were + or greater and (b) there were no erythema reactions in controls.

Results and discussion

Positive control results:
None

Any other information on results incl. tables

Camphor white oil at 0.15 % (ICC) and 30 % (ACC) did not cause skin sensitization.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
Under the test conditions, Camphor white oil was found to be a non-sensitiser to skin of guinea pigs in a modified draize procedure.
Executive summary:

In a modified draize procedure, ten guinea pigs were intradermally induced with 0.1 mL aliquots of Camphor white oil at 2.5 times the ICC at 4 sites which overlie the 2 auxiliary and 2 inguinal lymph nodes. Fourteen days later each animal was challenged intradermally in one flank and topically (uncovered) in the other flank with 0.1 mL aliquots of test substance at the respective ICC (0.15 %) and ACC (30 %). Twenty-four hours later the reactions were scored and apparent sensitization reactions confirmed 7 days later by a second challenge with controls included. At each challenge with controls, 4 previously untreated animals of the same sex were treated intradermally and topically on opposite flanks with 0.1 mL aliquots of test substance at the ICC and ACC respectively. Preliminary study was conducted to determine the concentrations for main study.

Camphor white oil at 0.15 % (ICC) and 30 % (ACC) did not cause skin sensitization.

 

Under the test conditions, Camphor white oil was found to be a non-sensitiser to skin of guinea pigs in a modified draize procedure.