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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16 Jul - 14 Aug 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 24 Apr 2002
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
Commission Directive No. 2004/73/EC
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
THE DEPARTMENT OF HEALTH OF THE GOVERNMENT OF THE UNITED KINGDOM

Test material

Constituent 1
Chemical structure
Reference substance name:
Vinyl benzoate
EC Number:
212-214-3
EC Name:
Vinyl benzoate
Cas Number:
769-78-8
Molecular formula:
C9H8O2
IUPAC Name:
vinyl benzoate

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan UK Limited, Bicester, Oxon, UK
- Age at study initiation: 12 - 20 weeks
- Weight at study initiation: 2.0 - 3.5 kg
- Housing: individually in suspended cages
- Diet: 2030 Teklad Global Rabbit diet (Harlan Teklad, Blackthorn, Bicester, Oxon, UK), ad libitum
- Water: drinking water, ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL
Duration of treatment / exposure:
Initial test: 3 min, 1 and 4 h
Confirmatory test: 4 h
Observation period:
14 days
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm on the dorsal/flank area of the trunk
- Type of wrap if used: Each gauze patch was secured in position with a strip of surgical adhesive tape and the trunk of the rabbit was wrapped in an elasticated corset.

REMOVAL OF TEST SUBSTANCE
- Washing: Any residual test material was removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: Initial test: 3 min, 1 and 4 h; Confirmatory test: 4 h

OBSERVATION TIME POINTS
1, 24, 48 and 72 h and Day 7 and 14

SCORING SYSTEM
- Method of calculation: Draize scoring system

OTHER OBSERVATIONS
Body weights were measured before dosing (Day 0) and on Day 14.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
4 h exposure
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Remarks:
4 h exposure
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Remarks:
4 h exposure
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Remarks:
4 h exposure
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Remarks:
4 h exposure
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks:
Crust formation prevents evaluation of edema on Day 7 and slight edema was observed on Day 14.
Irritation parameter:
edema score
Remarks:
4 h exposure
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Remarks:
4 h exposure
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Remarks:
4 h exposure
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
1.44
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
3 min exposure period:
Very slight erythema was noted at the treated skin site at the 24-hour observation. Well-defined erythema and very slight oedema were noted at the treated skin site at the 48 and 72-hour observations. The reaction extended approximately 3 cm beyond the treatment site at the 24 and 48-hour observations. Crust formation was noted at the treated skin site at the 7-day observation and slight desquamation was noted at the 14-day observation.

1 h exposure period:
Very slight erythema was noted at the treated skin site one hour after patch removal. Well-defined erythema and very slight to slight oedema were noted at the treated skin site at the 24, 48 and 72-hour observations. The reaction extended approximately 3 cm beyond the treatment site at the 24, 48 and 72-hour observations. Crust formation, which prevented accurate evaluation of erythema and oedema, was noted at the treated skin site at the 7-day observation. Slight desquamation was noted at the treated skin site at the 14-day observation.

4 h exposure period:
Well-defined erythema and very slight oedema were noted at two treated skin sites and very slight erythema was noted at one treated skin site one hour after patch removal. Well-defined erythema and very slight to slight oedema were noted at all treated skin sites at the 24, 48 and 72-hour observations. The reaction extended approximately 3 cm beyond one treatment site at the 24, 48 and 72-hour observations. Blanching of the skin was noted at one treated skin site at the 24, 48 and 72-hour observations. Light brown discolouration of the epidermis was noted at the one treated skin site at the 72-hour observation. Loss of skin flexibility and/or elasticity was noted at two treated skin sites at the 48-hour observation and at all treated skin sites at the 72-hour observation. Crust formation was noted at all treated skin sites at the 7-day observation and prevented accurate evaluation of erythema and oedema at one treated skin site. Slight desquamation was noted at one treated skin site and two treated skin sites appeared normal at the 14-day observation.
Other effects:
All animals showed expected gain in bodyweight during the study.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
Vinyl benzoate was tested for skin irritation in 3 rabbits according to the OECD TG 404. With respect to the findings reported at reading time points 24, 48 and 72 h for the 3 animals, the resulting mean Draize scores for erythema and edema were < 2.3, respectively; thus no classification according the CLP Regulation is warranted and the compound is considered not to be a skin irritant according to the CLP criteria.