Registration Dossier
Registration Dossier
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EC number: 947-975-7 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16/1/1996 to 14/2/1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
- Principles of method if other than guideline:
- Method
Six (6) New Zealand white rabbits each received a single dermal application of one-half of one millilitre (0.5 ml) of the test article on two (2) test sites, one (1) abraded and one (1) non-abraded. The test sites were occluded for 24 hours and were observed individually for erythema, edema and other effects 24 and 72 hours after application. Mean scores from the 24 and 72 hour readings were averaged to determine the primary irritation index. The test article was used as a ten (10) percent dilution in corn oil. - GLP compliance:
- not specified
Test material
- Reference substance name:
- tridecyl 2-hydroxybenzoate
- EC Number:
- 947-975-7
- Molecular formula:
- C20H32O3
- IUPAC Name:
- tridecyl 2-hydroxybenzoate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Not supplied
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: One abraded and one non-abraded site on each animal
- Vehicle:
- other: corn oil
- Amount / concentration applied:
- 0.5 ml as 10 % solution in corn oil
- Duration of treatment / exposure:
- 72 hours
- Observation period:
- The test sites were observed individually for erythema, edema and other effects 24 and 72 hours after application.
- Number of animals:
- 6
- Details on study design:
- Six (6) New Zealand white rabbits each received a single dermal application of one-half of one millilitre (0.5 ml) of the test article on two (2) test sites, one (1) abraded and one (1) non-abraded. The test sites were occluded for 24 hours and were observed individually for erythema, edema and other effects 24 and 72 hours after application. Mean scores from the 24 and 72 hour readings were averaged to determine the primary irritation index. The test article was used as a ten (10) percent dilution in corn oil.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 1.7
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 1.7
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 1.7
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- ca. 1.7
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- ca. 1.7
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- ca. 1.7
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Conclusions:
- According to Federal Hazardous Substances Act Regulations, (16 CFR 1500.41), and under the conditions of this test, this article is not a primary dermal irritant.
- Executive summary:
Method
Six (6) New Zealand white rabbits each received a single dermal application of one-half of one millilitre (0.5 ml) of the test article on two (2) test sites, one (1) abraded and one (1) non-abraded. The test sites were occluded for 24 hours and were observed individually for erythema, edema and other effects 24 and 72 hours after application. Mean scores from the 24 and 72 hour readings were averaged to determine the primary irritation index. The test article was used as a ten (10) percent dilution in corn oil.
Results
Primary irritation index: 1.70
Conculsion
According to Federal Hazardous Substances Act Regulations, (16 CFR 1500.41), and under the conditions of this test, this article is not a primary dermal irritant.
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