Registration Dossier
Registration Dossier
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EC number: 202-284-3 | CAS number: 93-89-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1985-04-11 to 1985-04-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study conducted according to GLP and OECD Guideline.
- Justification for type of information:
- For justification of read across see section 13.
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1985-04-11 to 1985-04-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Nottingham University, School of Agriculture, Sutton Bonington, Leicestershire
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.24-2.66 kg
- Housing: single
- Diet: ad libitum, Rabbit Diet (A.W. Tindall Limited, Holbeach, Lincolnshire)
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1.0
- Humidity (%): 51-55
- Air changes (per hr): approximately 10
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- examination of the test site at 1, 24, 48 and 72 hours after patch removal
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: back
- Type of wrap if used: The trunk of each rabbit was wrapped in an elasticated corset.
REMOVAL OF TEST SUBSTANCE
- Washing: swabbing with cotton wool soaked in ether
- Time after start of exposure: 4 hours (after removal of the patch)
SCORING SYSTEM: after Draize J.H. (1959) Association of Food and Drug Officials of the United States, Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- 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
- 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
- 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
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The test material produced no evidence of primary cutaneous irritation in any rabbit throughout the 72 hours observation period. Desquamation extending beyond the site of application was observed in all three rabbits at the 72 hours reading only.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material produced no evidence of primary cutaneous irritation in any rabbit throughout the 72 hours observation period. The test material produced mean erythema and edema scores of 0 for all tested animals calculated over the time points 24, 48, 72 h and was classified as non-irritant to the skin.
- Executive summary:
The test material was applied to the clipped back of three New Zealand White rabbits. Therefore, 0.5 mL were applied under a semiocclussive dressing and fixed for a duration of 48 hours. Afterwards, the patches were removed and the test sites were examined at 1, 24, 48 and 72 hours after removal to score the reactions. The test material produced no evidence of primary cutaneous irritation in any rabbit throughout the 72 hours observation period. Desquamation extending beyond the site of application was observed in all three rabbits at the 72 hours reading only. The test material produced mean erythema and edema scores of 0 for all tested animals calculated oer the time points 24, 48, 72 h and was classified as non-irritant to the skin.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Ethyl benzoate
- EC Number:
- 202-284-3
- EC Name:
- Ethyl benzoate
- Cas Number:
- 93-89-0
- Molecular formula:
- C9H10O2
- IUPAC Name:
- ethyl benzoate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Nottingham University, School of Agriculture, Sutton Bonington, Leicestershire
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.24-2.66 kg
- Housing: single
- Diet: ad libitum, Rabbit Diet (A.W. Tindall Limited, Holbeach, Lincolnshire)
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1.0
- Humidity (%): 51-55
- Air changes (per hr): approximately 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- examination of the test site at 1, 24, 48 and 72 hours after patch removal
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: back
- Type of wrap if used: The trunk of each rabbit was wrapped in an elasticated corset.
REMOVAL OF TEST SUBSTANCE
- Washing: swabbing with cotton wool soaked in ether
- Time after start of exposure: 4 hours (after removal of the patch)
SCORING SYSTEM: after Draize J.H. (1959) Association of Food and Drug Officials of the United States, Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics"
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- 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
- 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
- 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
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The test material produced no evidence of primary cutaneous irritation in any rabbit throughout the 72 hours observation period. Desquamation extending beyond the site of application was observed in all three rabbits at the 72 hours reading only.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material produced no evidence of primary cutaneous irritation in any rabbit throughout the 72 hours observation period. The test material produced mean erythema and edema scores of 0 for all tested animals calculated over the time points 24, 48, 72 h and was classified as non-irritant to the skin.
- Executive summary:
The test material was applied to the clipped back of three New Zealand White rabbits. Therefore, 0.5 mL were applied under a semiocclussive dressing and fixed for a duration of 48 hours. Afterwards, the patches were removed and the test sites were examined at 1, 24, 48 and 72 hours after removal to score the reactions. The test material produced no evidence of primary cutaneous irritation in any rabbit throughout the 72 hours observation period. Desquamation extending beyond the site of application was observed in all three rabbits at the 72 hours reading only. The test material produced mean erythema and edema scores of 0 for all tested animals calculated oer the time points 24, 48, 72 h and was classified as non-irritant to the skin.
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