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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study, GLP status unclear, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Evaluation of the test method for skin irritation as prescribed by OECD and EEC
Author:
Jacobs G and Martens M
Year:
1987
Bibliographic source:
J. Toxicol.-Cut. & Ocular Toxicol. 6(3), 215-225

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Principles of method if other than guideline:
Cyclohexane was applied to shaved rabbit skin and erythema and oedema recorded (using Draize criteria) at 1, 24, 48, and 72 hr after removal of the patch. Observations continued thereafter every 2 days until dermal responses had resolved in at least one rabbit.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Cyclohexane
EC Number:
203-806-2
EC Name:
Cyclohexane
Cas Number:
110-82-7
Molecular formula:
C6H12
IUPAC Name:
cyclohexane
Details on test material:
- Name of test material (as cited in study report): cyclohexane
- Lot/batch No.: 3100
- Supplier: Merck, Brussels, Belgium
- Purity: no further details

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Proefstations voor Veeteelt (Merelbeke, Belgium)
- Age at study initiation: 9-24 weeks
- Weight at study initiation: 2.75-5.2 kg
- Housing: individual mesh wire bottom cages
- Diet: Conventional Laboratory diet ad libitum
- Water: Tap-water ad libitum
- Acclimatisation period: At least 7 days
- Normal housing conditions

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 hours, occluded
Observation period:
Animals examined for signs of erythema and oedema formation at 1, 24, 48 and 72 hr after removal of the test patch
Number of animals:
5 or 6 (not specified)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
for all animals, all timepoints
Time point:
24/48/72 h
Score:
1.93
Remarks on result:
other: time course information not available
Irritation parameter:
erythema score
Basis:
mean
Remarks:
maximum erythema score (Smax)
Time point:
other: 119 h (time of Smax)
Score:
2.56
Irritation parameter:
edema score
Basis:
mean
Remarks:
for all animals, all timepoints
Time point:
24/48/72 h
Score:
0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Conclusions:
Cyclohexane caused erythema (overall mean 1.93) when applied to shaved rabbit skin under occlusion for 4 hr. The magnitude of the response was below the threshold for classification.
Executive summary:

The skin irritation potential of cyclohexane toward shaved rabbit skin was evaluated according to Annex V of directive 67/548 EEC. The sample (0.5 mL) was applied under occlusion for 4 hr with an area of untreated skin serving as control. The overall mean score for erythema (all animals over all times points) was 1.93; no oedema was reported. The results indicate that cyclohexane is not irritating to rabbit skin.

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