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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No description of GLP compliance is available

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: U.S. Federal Hazardous Substances Labeling Act, CFR 1500.41 Hazardous Substances and Articles, Administration and Enforcement Regulations, Federal Register, Vol. 38, No. 187, September 1973
Deviations:
not specified
Principles of method if other than guideline:
U.S. Federal Hazardous Substances Labeling Act, CFR 1500.41 Hazardous Substances and Articles, Administration and Enforcement Regulations, Federal Register, Vol. 38, No. 187, September 1973
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
T-1746IE
IUPAC Name:
T-1746IE
Constituent 2
Chemical structure
Reference substance name:
Isooctyl acrylate
EC Number:
249-707-8
EC Name:
Isooctyl acrylate
Cas Number:
29590-42-9
Molecular formula:
C11H20O2
IUPAC Name:
6-methylheptyl acrylate
Details on test material:
- Name of test material (as cited in study report: T-1746IE
- Physical state: Liquid

Test animals

Species:
rabbit
Strain:
other: Albino

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: intact and abraded
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
24hours
Observation period:
Readings were made at 24 and 72 hours
Number of animals:
6
Details on study design:
TEST SITE
- Type of wrap if used: Gauze patches were placed over the treated areas and an impervious material was wrapped snugly around the trunks of the animals to hold the patches in place.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not washed

SCORING SYSTEM: Draize Scoring; 0-4 for erythema and eschar formation, and 0-4 for edema formation. Scores were determined at 24 and 72 hours. Scores were totaled and divided by 4 to determine the primary irritation score (maximum 8.0)

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
other: PII Calculation
Time point:
other: 24/72 h
Score:
ca. 1
Irritant / corrosive response data:
Not a primary dermal irritant

Any other information on results incl. tables

Scores of 1 were obtained for all animals at 24 and 72 hours for erythema and eschar formation for both intact and abraded skin. Scores of 0 were obtained for all animals at 24 and 72 hours for edema formation for both intact and abraded skin. The primary irritation score was calculated to be 1.0/8.0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: US CPSC / US OSHA
Conclusions:
The test material was not a primary dermal irritant based on the test conditions.
Executive summary:

Undiluted test material (0.5 ml) was applied to intact and abraded skin of 6 albino rabbits. Gauze patches and impervious dressing were placed over the test sites for 24 hours. Skin was examined at 24 and 72 hours to determine irritation scores. The Draize method of scoring was used. Scores of 1 were obtained for all animals at 24 and 72 hours for erythema and eschar formation for both intact and abraded skin. Scores of 0 were obtained for all animals at 24 and 72 hours for edema formation for both intact and abraded skin. The primary irritation score was calculated to be 1.0/8.0. The test material was not a primary dermal irritant based on the test conditions.