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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
Study period:
1985-04-16 to 1985-04-21
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Older GLP guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Benzyl salicylate; RIFM 28
- Substance type: No data
- Physical state: Liquid
- Analytical purity: No data
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: No data
- Lot/batch No: No data
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: No data

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: A Smith, 7 Kydcomb Road, Warlingham, Surrey, United Kingdom.
- Age at study initiation: No data
- Weight at study initiation: No data
- Housing: Individually in anodised aluminium cages with grid floors and no bedding materials.
- Diet: Ad libitum, commercial pelleted rabbit diet (680, Dalgety-Spillers Ltd)
- Water: Mains tap water (presumably ad libitum)
- Acclimation period: ≥ 5 d.

ENVIRONMENTAL CONDITIONS
- Temperature: 18 °C - 22 °C
- Humidity: 42 % - 65 %
- 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:
4 female

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 552
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
edema score
Basis:
animal: 552
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hrs
Irritation parameter:
erythema score
Basis:
animal: 554
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Basis:
animal: 554
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal: 556
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
edema score
Basis:
animal: 556
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal: 557
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hrs
Irritation parameter:
edema score
Basis:
animal: 557
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible
Remarks:
48 hr
Irritant / corrosive response data:
Based on the mean scores (24, 48 and 72-hour observations) of each of the four rabbits, the overall mean score per observed reaction is:
Oedema: 0.2
Erythema: 0.6
Other effects:
None noted.

Any other information on results incl. tables

The numerical values or scores given to the erythema observed in each animal of the treated group at the 24, 48 and 72- hour examinations were summed. This total was then divided by three, the number of examinations that the figures were taken from, and further divided by the number of animals in the group. The values obtained in assessing oedematous reaction were similarly treated. The average scores obtained may be used in any subsequent classification of the material, a value of 2 or more for either erythema or oedema resulting in the material being regarded as irritant.

The maximum score recorded in the table above represents the maximum score attainable and not the maximum observed score in any single animal.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Following the application of ca. 0.5mL of neat test substance to the shorn flanks of 3 rabbits for 4 hours very slight erythema and oedema were observed up to 72 hours after dosing. All reactions were reversible 7 days after dosing.
Executive summary:

Approximately 0.5mL of neat test substance was applied to the shorn flanks of three rabbits, wrapped in semi-occlusive dressing for a period of four hours. One hour after the dosing period well defined erythema of the treated skin was apparent in one rabbit and very slight erythema was observed in the remaining three rabbits of the group. Slight oedema was noted in one rabbit and very slight oedematous reaction was observed in the treated skin of the second rabbit at this time. Very slight erythema remained in three rabbits at twenty four hour observation, very slight oedema also being observed in two rabbits. This response declined, very slight erythema remaining in two animals 72 hours after dosing and no irritation remaining visible 7 days after dosing. The averages calculated from the numerical values given to the irritation observed at the 24, 48 and 72 -hour observations were 0.6 for erythema and 0.2 for oedema.

The effects seen do not trigger classification according to Regulation (EC) No. 1272/2008 (CLP).