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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:
key study
Study period:
1985-01-7 to 1985-01-16
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable without restrictions because it is an acceptable and well-documented study report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
IUCLID4 Test substance: other TS: Odourless kerosine
- Name of test material (as cited in study report):
- Substance type: Kerosine
- Physical state: Liquid
- Expiration date of the lot/batch: January 1985
- Storage condition of test material: In the dark, at ambient temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Sittingbourne Research Centre breeding colony
- Age at study initiation: 3 to 6 months
- Weight at study initiation: 3.4 kg to 4.9 kg
- Housing: Individual
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 2 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 to 19 °C
- Humidity (%): monitored
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL applied undiluted
Duration of treatment / exposure:
4 hour(s)
Observation period:
7 days
Number of animals:
3 male, 3 female
Details on study design:
TEST SITE
- Area of exposure: 2 cm x 2 cm
- % coverage: no data
- Type of wrap if used: gauze, elastic adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): None
- Time after start of exposure: 4 hours

SCORING SYSTEM: Scale of 0 to 4 for both erythema and edema

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 to 72 hours
Score:
0.17
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 to 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
The only skin reaction was barely perceptible erythema in all but one rabbit at 24 hours, but this cleared by 48 hours post-exposure.

Any other information on results incl. tables

The only skin reaction was a barely perceptible erythema which persisted in all rabbits at 24hours post dosing but had cleared by 48 hours.
Group mean scores (24, 48 and 72 hrs) were:
Erythema:
       0.17
Edema:
         0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The group mean 24, 48, and 72 hour scores for erythema and edema were 0.17 and 0.0 respectively. Under the conditions of this study, the test material was classified as not irritating according to EU criteria.
Executive summary:

In a skin irritation study, three male and three female rabbits were treated with 0.5 mL of undiluted test material. The test material was applied to a single shorn area of skin and covered by a layer of gauze. The wrapping was removed after four hours of exposure and the site was scored for erythema and edema at 30 minutes after patch removal, and at 24, 48, and 72 hours and 7 and 14 days after application. The group mean 24, 48, and 72 hour scores for erythema and edema were 0.17 and 0.0 respectively. Under the conditions of this study, the test material was classified as not irritating according to EU criteria.

This study received a Klimisch score of 1 and is classified as reliable without restrictions because it is an acceptable and well-documented study report.