Registration Dossier
Registration Dossier
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EC number: 202-288-5 | CAS number: 93-92-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Not stated
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in accordance with generally accepted scientific principles, but incomplete reporting on results and discussion, which do not affect the quality of the relevant results. With the exception of the contact period, and testing on abraded skin, the guideline used shares the same basic principles as the OECD guideline 404. The use of an occlusive patch, a longer contact time (24 hours instead of 4) and abrading the skin would produce a result bias towards irritation and as such represents a worst case. As no irritation was induced during the study, the results are considered to be a true and accurate reflection of the effects of the test substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 971
- Report date:
- 1971
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Association of Food and Drug Officials of the United States, Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, 1959, pp 46-48
- Deviations:
- not specified
- GLP compliance:
- no
Test material
- Reference substance name:
- 1-phenylethyl acetate
- EC Number:
- 202-288-5
- EC Name:
- 1-phenylethyl acetate
- Cas Number:
- 93-92-5
- Molecular formula:
- C10H12O2
- IUPAC Name:
- 1-phenylethyl acetate
Constituent 1
- Specific details on test material used for the study:
- - Name of test material: 1-phenylethyl acetate
- Name of test material (as cited in study report): USA2850 Methyl Phenyl Carbinyl Acetate (styrallyl acetate)
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Weight at study initiation: 2-2.5 kg- Housing: in accordance with standard laboratory procedure- Diet (e.g. ad libitum): in accordance with standard laboratory procedure- Water (e.g. ad libitum): ad libitum
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: Shaved, abraded and non-abraded sites were used
- Vehicle:
- not specified
- Controls:
- no
- Amount / concentration applied:
- TEST SUBSTANCE- Amount applied: 0.5 mLThe test substance was applied to abraded and non-abraded skin at 4 sites (2 abraded, 2 non-abraded). The abrasions were minor incisions through the stratum corneum, but not sufficient deep to disturb the derma (not to produce bleeding).
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- Readings were made at 24, 48 and 72 hours after the prescribed exposure period.
- Number of animals:
- 6
- Details on study design:
- TEST SITE- Area of exposure: 1 inch patch- Type of wrap if used: The patches were secured in place with adhesive tape. The entire trunk of the animal was wrapped with rubberized cloth the entire 24-hour period of exposure. The animals are immobilised in an animal holder.SCORING SYSTEM:Evaluation of the skin reaction for erythema and edema was scored in line with the method followed.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24/48/72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within:
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No irritation recorded during the course of the study.
Any other information on results incl. tables
Table 2: Readings
24 hours 48 hours 72 hours Erythema Edema Erythema Edema Erythema Edema 1 NA 0 0 0 0 0 0 A 0 0 0 0 0 0 A 0 0 0 0 0 0 NA 0 0 0 0 0 0 2 NA 0 0 0 0 0 0 A 0 0 0 0 0 0 A 0 0 0 0 0 0 NA 0 0 0 0 0 0 3 NA 0 0 0 0 0 0 A 0 0 0 0 0 0 A 0 0 0 0 0 0 NA 0 0 0 0 0 0 4 A 0 0 0 0 0 0 NA 0 0 0 0 0 0 NA 0 0 0 0 0 0 A 0 0 0 0 0 0 5 A 0 0 0 0 0 0 NA 0 0 0 0 0 0 NA 0 0 0 0 0 0 A 0 0 0 0 0 0 6 A 0 0 0 0 0 0 NA 0 0 0 0 0 0 NA 0 0 0 0 0 0 A 0 0 0 0 0 0
A = abraded; NA = non-abraded
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the test, the test substance was not considered to be a skin irritant.
- Executive summary:
In a pre-GLP skin irritation study conducted in line with the Association of the Food and Drug Officials of the United States: Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics, 1959 pp 49-51, the test substance was determined not to be a skin irritant.
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