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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:
05 December 1991 to 08 December 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted under GLP conditions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Liquid
Details on test material:
- Name of test material (as cited in study report: T-5452
- Substance type: Colorless liquid
- Physical state: Liquid
- Storage condition of test material: Stored at room temperature

Test animals

Species:
rabbit
Strain:
other: Hra: (NZW) SPF
Details on test animals and environmental conditions:
TEST ANIMALS
- Sex: male
- Source: Hazleton Research Products, Inc., Kalamazoo MI, U.S.A.
- Age at study initiation: No data.
- Weight at study initiation: 2292-2326 g.
- Fasting period before study: No data
- Housing: No data
- Diet (e.g. ad libitum): High Fiber Riabbit Chow #5326, Purina Mills, Inc., ad libitum.
- Water (e.g. ad libitum): Ad libitum.
- Acclimation period: At least 7 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.9-23.9
- Humidity (%): 41-53
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 05 December 1991To: 08 December 1991

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm by 2.5 cm.
- % coverage: No data
- Type of wrap if used: Saran Wrap (semiocclusive dressing).
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washed immediately after 4 hour exposure.
- Time after start of exposure: 4 hours after exposure.
SCORING SYSTEM: Draize technique.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 4, 24, 48, and 72 hours.
Score:
ca. 0
Reversibility:
fully reversible
Remarks on result:
other: No erythema or edema was observed at any time point in any animal after exposure to the test article.
Irritant / corrosive response data:
No erythema or edema was observed at any time point in any animal after exposure to the test article.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
No erythema or edema was observed at any time point in any animal after exposure to the test article. The test article is considered non-irritating to the skin under the conditions of this study.
Executive summary:

A primary dermal irritation study (OECD Guideline 404) was conducted using three albino rabbits (New Zealand White strain). Each rabbit received a 0.5 milliliter applications of the test article to an intact skin test site. The test sites were covered with a semi-occlusive dressing for 4 hours and washed after test article removal. The sites were evaluated for irritation immediately after test article removal (4 hour), 24, 48 and 72 hours. Application of the test article to the skin of albino rabbits under 4 hour semi-occluded conditions resulted in no dermal irritation. An average primary dermal irritation score of 0.0 of a possible 8.0 was assigned at all evaluations. The test article is considered non-irritating to the skin under the conditions of this study.