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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 49CFR, Section 173.240(a)(2)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hazelton Dutchland, Denver, Pennsylvania
- Age at study initiation: 13-18 weeks
- Weight at study initiation: not reported
- Housing: not reported
- Diet (e.g. ad libitum): not reported
- Water (e.g. ad libitum): not reported
- Acclimation period: not reported


ENVIRONMENTAL CONDITIONS- not reported



IN-LIFE DATES: From: June 26, 1984 To: July 31, 1984

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
undiluted
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): not applicable


VEHICLE no vehicle
Duration of treatment / exposure:
4 hour(s)
Observation period:
14 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: clipped intact skin on the back
- % coverage: not reported
- Type of wrap if used: entire trunk of each animal was wrapped with a polyethylene sheet and an impervious cuff secured with adhesive tape for 4 hr.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): application sites were wiped gently with paper towels moistened with 80% (v/v) ethanol in water
- Time after start of exposure: 24 hours


SCORING SYSTEM: Draize

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 72-hr
Score:
7.3
Reversibility:
not reversible
Irritant / corrosive response data:
AVERAGE SCORE - Erythema: 4.0 - Edema: 3.3 REVERSIBILITY: no
Other effects:
On Day 21, severe erythema with eschar (in all rabbits) and eschar sloughing off with hair growth beneath it (in 5 of the 6 rabbits) was observed. Desiccation was also observed. On Day 28, no erythema or edema was observed. Three rabbits had hair growth over entire site with a small area that was hard to the touch. The other rabbits had possible scar formation. The one remaining rabbit's skin site appeared normal. On Day 35, no erythema or edema was observed. One rabbit had a white linear striation on the application site and possible scar formation. Four of the six rabbits had a small area that was hard to the touch and hair growth covering the entire application site.

Applicant's summary and conclusion

Interpretation of results:
Category 1B (corrosive) based on GHS criteria
Conclusions:
Based on the severe and persisting dermal reactions, and the possible scar formation underneath the skin, the test substance is considered corrosive to the skin of rabbits.