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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:
other information
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Documentation insufficient for assessment, test performance not accorting to OECD guideline 404

Data source

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

Materials and methods

Principles of method if other than guideline:
Irritating potential of the test substance was judged using the first induction of a Buehler test.
Theh test was performed with 20 female animals in the treatment group and 5 animals in the challenge control group.
Single Webril patches containing 0.4ml test substance were applied to the clipped left shoulder. 6 hours later patches and test substance were removed. This induction procedure was repeated 3x on 3 subsequent weeks but for the evaluation of skin irritation only the readings of the first induction are reported here. Following each induction test sites were scored for dermal irritation.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Caprolactam
- Physical state: white flakes
- Lot/batch No.: S1:600142 F from BASF Corporation Chemicals Division, New Jersey
- Expiration date of the lot/batch: none provided
- Storage condition of test material: room temperature

Test animals

Species:
guinea pig
Strain:
Hartley

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Concentration (if solution): 75 % in water


Duration of treatment / exposure:
6 hour(s)
Observation period:
24 and 48 h post exposure
Number of animals:
20
Details on study design:
TEST SITE
- Type of wrap if used: Webril patch containing 0.4 ml of the test substance


REMOVAL OF TEST SUBSTANCE
- Washing (if done): test article residue was removed using gauze moistened with distilled water
- Time after start of exposure: 6 h


SCORING SYSTEM:
The test sites were graded for irritation according to the following scale:
0 - No reaction
± - Slight patchy erythema
1 - Slight but confluent or moderate patchy erythema
2 - Moderate confluent erythema
3- Severe erythema with or without edema

Results and discussion

Any other information on results incl. tables

Experiment 1 (Bühler test 322.3)

Dermal irritation score 24 h after 1st induction: ± in 10/20 animals

Dermal irritation score 48 h after 1st induction: ± in 3/20 animals

No increased incidence of skin irritation occured 24 or 48 h after the first induction in the Buehler test for skin sensitization.

Applicant's summary and conclusion