Registration Dossier
Registration Dossier
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EC number: 203-860-7 | CAS number: 111-34-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- adopted 1992
- GLP compliance:
- yes
- Remarks:
- (BASF AG, Dep. of Toxicology)
Test material
- Reference substance name:
- Butyl vinyl ether
- EC Number:
- 203-860-7
- EC Name:
- Butyl vinyl ether
- Cas Number:
- 111-34-2
- Molecular formula:
- C6H12O
- IUPAC Name:
- 1-(ethenyloxy)butane
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. Thomae GmbH (FRG)
- Age at study initiation: young adult, no further data
- weight at study initiation: 3.73 (male), 3.98 (female), and 3.99 (females) kg
- Housing: singly
- certified diet and tap water ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin
- Amount / concentration applied:
- 0.5 mL undiluted TS
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 1, 24, 48, and 72 hours and 8 & 15 days after removal of the patches
- Number of animals:
- 3
- Details on study design:
- The fur was clipped at least 24 hrs before treatment.
Application: A pad (2.5 cm x 2.5 cm) soaked with 0.5 mL of undiluted TS was placed to the shaved, intact rabbit's dorsal skin (secured by semi-occlusive dressing). At the end of the contact period excess test substance was washed off.
Observations, examinations: Skin reactions were examined 1, 24, 48, and 72 hours and 8 & 15 days after removal of the patches
Data evaluation: Skin reactions were scored according to the table of Draize contained in the OECD TG 404.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 15 d
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 15 d
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 15 d
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 8 days
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 15 d
- Remarks on result:
- other: scaling in 2 rabbits
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 15 days
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: scaling in 3/3 rabbits, erythema score 1 in one rabbit (other score 0)
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1, 24, or 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritant / corrosive response data:
- The effects extended beyond the area of exposure.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The undiluted test substance was irritating to the rabbit skin.
- Executive summary:
Guideline study
Three New Zealand White rabbits received dermal application 0.5 mL undiluted BVE to the shaved skin under semi-occlusive dressing for 4 h (washing at termination). Scoring was performed 1, 24, 48, and 72 hours and 8 & 15 days after removal of the patches. The mean score for erythema was 3.0, 2.7, and 2.7 24, 48, and 72 h after patch removal, respectively. Erythema was not reversible in one rabbit at termination and all three rabbits showed scaling of the skin (day 15). Edema reached only score 1 24 -72 h after patch removal and was reversible within 8 days.
Conclusion: The undiluted test substance was irritating to the rabbit skin.
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