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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated 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:
other: Study conducted according to GLP and OECD Guideline. For justification of read across see section 13.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
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

Constituent 1
Reference substance name:
Methyl benzoate
EC Number:
202-259-7
EC Name:
Methyl benzoate
Cas Number:
93-58-3
IUPAC Name:
methyl benzoate
Test material form:
other: liquid

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: 20+/-1.0°C
- 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:
other: (24 h /48 h/ 72 h)
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: (24 h /48 h/ 72 h)
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: (24 h /48 h/ 72 h)
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24 h / 48 h / 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24 h / 48 h / 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24 h / 48 h / 72 h
Score:
0
Max. score:
4
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:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
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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