Registration Dossier
Registration Dossier
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EC number: 203-545-4 | CAS number: 108-05-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Study plan finalized 06 February 2003 and report issued 28 March 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
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 (incl. QA statement)
Test material
- Reference substance name:
- Vinyl acetate
- EC Number:
- 203-545-4
- EC Name:
- Vinyl acetate
- Cas Number:
- 108-05-4
- Molecular formula:
- C4H6O2
- IUPAC Name:
- ethenyl acetate
- Details on test material:
- - Name of test material (as cited in study report): Vinylacetate (stabilised)
- Physical state: Liquid
- Analytical purity: 99.9%
- Lot/batch No.: 29.01.2003
- Expiry date: 30 April 2003
- Storage condition of test material: In the original container, in the refrigerator (range of 2 to 8°C)
Constituent 1
- Specific details on test material used for the study:
- Vinyl Acetate
Liquid
Batch No. 29.01.2003
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Scientifique des Dombes, F-01400 Chatillon sur Chalaronne, France
- Age at study initiation: 11 weeks (male), 12 and 13 weeks (females)
- Weight at study initiation: 2353 g (male), 2156 and 2179 g (females)
- Housing: Individually in stainless steel cages
- Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum
- Water: Community tap water ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 17-23°C
- Humidity: 30-70%
- Air changes (per hr): 10-15
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: 10 March 2003 To: 17 March 2003
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Four days before treatment, one flank was clipped with an electric clipper, exposing an area of approximately 100 cm2 (10 cm x 10 cm). The skin of the animals was examined one day before treatment, and regrown fur of all animals was again clipped.
- On the day of treatment, 0.5 mL of VINYLACETATE (STAB.) was placed on a surgical gauze patch (ca. 4 cm x 4 cm). This gauze patch was applied to the intact skin of the clipped area. The patch was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Skin was flushed with lukewarm tap water after removal of the dressing
- Time after start of exposure: 4 hrs
SCORING SYSTEM: The skin reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992 approximately 1, 24, 48 and 72 hours after the removal oval of the dressing, gauze patch and test item.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hrs
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hr
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hrs
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect observed
- Remarks on result:
- no indication of irritation
- Other effects:
- None
Any other information on results incl. tables
Individual mean erythema scores for 24, 48 and 72 hours were 0.67, 0.33 and 0.00. Very slight erythema was observed in two animals 24 hours after treatment and persisted in one animal up to the 48-hour examination. Individual mean oedema scores for 24, 48, and 72 hours were 0.0, 0.0 and 0.0.
The overall mean scores for 24, 48 and 72 hours were 0.33 for erythema and 0.0 for oedema.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: OECD and EU
- Conclusions:
- VINYLACETATE (STAB.) is considered to be "not irritating" to rabbit skin.
- Executive summary:
The primary skin irritation potential of VINYLACETATE (STAB.) was investigated according to OECD test guideline no. 404. The test item was applied by topical semi-occlusive application of 0.5 mL to the intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing. The mean scores were calculated across 3 scoring times(24, 48 and 72 hours after patch removal) for each animal for erythema/eschar and for oedema, separately. VINYLACETATE (STAB.) caused mild signs of irritation, including erythema, but this was reversible within 72 hours of treatment. There was no siignificant or irreversible damage to the skin. The overall mean erythema/eschar score of the three animals was 0.33 and the overall mean oedema score was 0.00. Based upon the referred classification criteria (Commission Directive 2001/59/EC of August 06, 2001), VINYLACETATE (STAB.) is considered to be "not irritating" to rabbit skin.
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