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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:
7 December 1993 - 14th December 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Benzyl acetate
- Physical state: Clear liquid
- Analytical purity: 99.6%
- Lot/batch No.: T521/41/0
- Expiration date of the lot/batch: April 1994
- Storage condition of test material: Room temperature in the dark
Specific details on test material used for the study:
- Name of test material (as cited in study report): Benzyl acetate
- Physical state: Clear liquid
- Analytical purity: 99.6%
- Lot/batch No.: T521/41/0
- Expiration date of the lot/batch: April 1994
- Storage condition of test material: Room temperature in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Froxfield (U .K.) Ltd., Petersfield, Hampshire, England.
- Age at study initiation: 12 to 13 weeks
- Weight at study initiation: 2.7 to 3.1 kg
- Housing: individually in metal cages with perforated floors
- Diet (e.g. ad libitum): A standard laboratory diet SDS Stanrab (P) Rabbit Diet ad libitum
- Water (e.g. ad libitum):ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C
- Humidity (%): 30 -70%.
- Air changes (per hr): 19 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light in each 24 hours period

IN-LIFE DATES: From: 7 December, 1993 To: 14 December, 1993

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 m1

Duration of treatment / exposure:
4 hours
Observation period:
8 days
Number of animals:
3 animals
Details on study design:
TEST SITE
- Area of exposure: 25 mm x 25 mm
- % coverage: 100%
- Type of wrap if used: gauze pad covered with "Elastoplast" elastic adhesive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with warm water (30° to 40°C) to remove any residual test substance. The treated area was blotted dry with absorbent paper.
- Time after start of exposure: 4 hours

SCORING SYSTEM:
Local dermal irritation was assessed using the standard Draize numerical system:
Erythema and eschar formation:
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) preventing erythema reading 4
Oedema formation:
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (raised approximately 1 millimetre) 3
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure) 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.89
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible
Irritant / corrosive response data:
The numerical values given to the dermal reactions elicited by Benzyl acetate are shown in the table below.
Very slight to well-defined with or without very slight oedema developed in two animals. These reactions had resolved by Day 4 or 8.
No dermal reactions were seen in the third animal.
Other effects:
There were no signs of toxicity or ill health in any rabbit during the observation period.

Any other information on results incl. tables

No additional information

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
A single semi-occlusive application of Benzyl acetate to intact rabbit skin for four hours elicited very slight to well-defined dermal reactions. According to Regulation (EC) No. 1272/2008, no classification is warranted.
Executive summary:

A study was performed to assess the skin irritation potential of Benzyl acetate to the rabbit. Three rabbits were each administered a single dermal dose of 0.5 ml of the test substance and observed for a maximum of eight days. A single semi-occlusive application of Benzyl acetate to intact rabbit skin for four hours elicited very slight to well-defined dermal reactions. All reactions had resolved by Day 4 or 8. According to Regulation (EC) No. 1272/2008, no classification is warranted.