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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Older GLP study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: Annex V test methods EEC Directive 79/831.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Liquid
Details on test material:
- Name of test material (as cited in study report): Benzyl salicylate
- Molecular formula (if other than submission substance):
- Molecular weight (if other than submission substance):
- Smiles notation (if other than submission substance):
- InChl (if other than submission substance):
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type:
- Physical state:
- Analytical purity:
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Isomers composition:
- Purity test date:
- Lot/batch No.:
- Expiration date of the lot/batch:
- Radiochemical purity (if radiolabelling):
- Specific activity (if radiolabelling):
- Locations of the label (if radiolabelling):
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions:
- Storage condition of test material:
- Other:

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Recognised breeders whose standards are acceptable to the animal welfare department of the testing facilities.
- Age at study initiation:
- Weight at study initiation:
- Housing: Individually in anodised wire mesh cages with no bedding.
- Diet: Ad libitum SQC standard rabbit diet (Special Diet Services Ltd, Witham, Essex, United Kingdom)
- Water: Ad libitum mains water
- Acclimation period: ≥ 5 d

ENVIRONMENTAL CONDITIONS
- Temperature: 18 °C to 23 °C
- Humidity: 40 % to 80 %:
- Air changes (per hr): No data
- Photoperiod: 12 hrs dark / 12 hrs light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Volume applied: 0.5 mL
Duration of treatment / exposure:
4 hrs
Observation period:
7 d (observations at 1 hr, 24 hrs, 48 hrs, 72 hrs, 7 d after removal of patch)
Number of animals:
3 females (each animal tested with multiple substances)
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm²
- Type of wrap if used: Elastoplast elastic adhesive barrier, 10 cm width.

REMOVAL OF TEST SUBSTANCE
- Washing: Adhesive tapes removed, gentle swabbing with cotton wool soaked in warm water
- Time after start of exposure: 4 hrs

SCORING SYSTEM:
- Erythema and eschar formation:
-- 0: No erythema
-- 1: Very slighty erythema (barely perceptible)
-- 2: Well-defined erythema
-- 3: Moderate to severe erythema
-- 4: Severe erythema (beet redness) to slight eschar formation (injuries in depth)
- Oedema formation:
-- 0: No oedema
-- 1: Very slight oedema (barely perceptible)
-- 2: Slight oedema (edges of area well defined by definite raising)
-- 3: Moderate oedema (raised approximately 1 mm)
-- 4: Severe oedema (raised more than 1 mm and extending beyond area of exposure)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
190
Time point:
other: Mean of 24, 48 and 72hrs
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 48 hr
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
201
Time point:
other: Mean of 24, 48 and 72 hrs
Score:
0.667
Max. score:
2
Reversibility:
fully reversible within: 72 hr
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
203
Time point:
other: Mean of 24, 48 and 72 hrs
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24 hrs
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
190
Time point:
other: mean of 24, 48 and 72 hrs
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24 hr
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
201
Time point:
other: Mean of 24, 48 and 72hrs
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 24 hr
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
203
Time point:
other: Mean of 24, 48 and 72 hrs
Score:
0
Max. score:
0
Irritant / corrosive response data:
No other abnormalities detected.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Following exposure to ca. 0.5 g of substance in contact with skin for four hours the substance is considered not to be a skin irritant to rabbits.
Executive summary:

Administration of ca. 0.5g of neat substance to the shorn flanks of three rabbits and wrapped in semi-occlusive tape for 4 hours resulted in well defined erythema and slight oedema after one hour observation at the treated site of one rabbit. Well defined erythema and very slight oedema was apparent at the treated skin site of a second rabbit and the treated skin of the remaining rabbit exhibited very slight erythema. Very slight erythema remained at the treated sites of two rabbits twenty four hours after dosing, the reaction declining in one rabbit by the forty-eight hour observation. No other irritant response was apparent after this time and all effects were reversible at the 72 -hour observation.

Under the conditions of the test, the substance is not considered to be a skin irritant.