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EC number: 224-081-9 | CAS number: 4196-89-8
Skin irritation / corrosion
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: Similar to the guideline of today, observation time 7 days, no GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Observation period 7 days
- GLP compliance:
- no
Test material
- Reference substance name:
- 2,2-dimethylpropane-1,3-diyl dibenzoate
- EC Number:
- 224-081-9
- EC Name:
- 2,2-dimethylpropane-1,3-diyl dibenzoate
- Cas Number:
- 4196-89-8
- Molecular formula:
- C19H20O4
- IUPAC Name:
- 3-(benzoyloxy)-2,2-dimethylpropyl benzoate
Constituent 1
- Specific details on test material used for the study:
- - yellowish white chunks
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2066-2380 g
- Housing: individually
- Diet ad libitum
- Water ad libitum
- Acclimation period: 9 days
ENVIRONMENTAL CONDITIONS
- temperature and humidity controlled quarters
- The animals were maintained in accordance with the recommendations contained in H.E.W. Publication No.74-23 (N.I.H.) entitled "Guide for the care and use of laboratory animals"
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped and 3/6 rabbits abraded
- Vehicle:
- not specified
- Controls:
- other: the opposite site of the back
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- up to 72 hours
- Number of animals:
- 6: 3/6 with intact skin and 3/6 with abraded skin
- Details on study design:
- 3 male and 3 female rabbits were used for this study. The hair was removed from the back of each rabbit (20-30% of the body surface) with an electric clipper. The skin of 3 of the rabbits was abraded with a scalpel blade. 500 mg of the test material was applied to the back of each rabbit and covered by semiocclusive dressing. The opposite site of the treated area served as control. Following 24 hours of application the bandages were removed and the application sites were washed with tepid water and examined for skin irritation. These examinations were repeated at 72 hours.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- other: mean animals with intact skin
- Time point:
- other: 24 hours
- Score:
- ca. 0 - ca. 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: 1/3 animals showed erythema score 1 of max 4 at 24 hours.
- Irritation parameter:
- erythema score
- Basis:
- other: mean animals with intact skin
- Time point:
- other: 72 hours
- Score:
- ca. 0
- Max. score:
- 4
- Remarks on result:
- other: No rabbit with intact skin showed erythema at 72 hours.
- Irritation parameter:
- edema score
- Basis:
- other: mean animals with intact skin
- Time point:
- other: 24 hours up to 72 hours
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: N edema were observed.
- Irritant / corrosive response data:
- Animals with abraded skin showed erythema up to erythema score 2 at 24 hours and at 72 hours. 2/3 animals showed no erythema and 1/3 animals showed score 1 erythema. 1/3 animals with abraded skin showed edema up to 72 hours (score 1/4). 2/3 animals showed no edema.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- 2,2-dimethylpropane-1,3-diyl dibenzoate has to be evaluated as minimal to slightly irritating to the skin of rabbits, which does not lead to classification or labelling.
- Executive summary:
3 male and 3 female rabbits were used for a skin irritation study similar to the respective OECD guideline. The hair was removed from the back of each rabbit (20-30% of the body surface) with an electric clipper. The skin of 3 of the rabbits was abraded with a scalpel blade. 500 mg of the test material was applied to the back of each rabbit and covered by semiocclusive dressing. The opposite site of the treated area served as control. Following 24 hours of application the bandages were removed and the application sites were washed with tepid water and examined for skin irritation. These examinations were repeated at 72 hours.
Based on the available results the primary irritation score was calculated to be 0.6. Thus 2,2-dimethylpropane-1,3-diyl dibenzoate has to be evaluated as minimal to slightly irritating to the skin of rabbits, which does not lead to classification or labelling.
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