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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:
1991-09-09 to 1991-09-17
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Date of inspection 1990-05-14

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzoic acid, 2-hydroxy-, mono-C14-18-alkyl derivs., calcium salts (2:1)
EC Number:
931-276-9
Cas Number:
114959-46-5
Molecular formula:
See information in Section 1.2.
IUPAC Name:
Benzoic acid, 2-hydroxy-, mono-C14-18-alkyl derivs., calcium salts (2:1)
Details on test material:
- Name of test material (as cited in study report): [CAS Number 114959-46-5]
- Physical state: Clear brown viscous liquid
- Lot/batch No.: 191 (Stanlow); DSP4767/91
- Toxicology reference number: ST91/247
- Stability under test conditions: Stable for the duration of the study under the test conditions employed
- Storage condition of test material: In the dark at ambient temperature under nitrogen
- Date received: 08 August 1991

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Froxfield Farms UK Ltd
- Age at study initiation: 3 to 5 months
- Weight at study initiation: 3.70-3.89 kg (males); 3.48-3.86 kg (females)
- Fasting period before study:
- Housing: Singly in hanging, stainless steel cages with perforated dimple or wire-mesh flooring. Sawdust-filled undertrays for excreta were placed beneath each cage and changed twice weekly. Each cage measured 91 cm x 66 cm x 45 cm.
- Diet (e.g. ad libitum): Pelleted diet (Standard Rabbit Diet, SQC, Special Diet Services Ltd) ad libitum
- Water (e.g. ad libitum): Water from the public supply ad libitum
- Acclimation period: At least two weeks

ENVIRONMENTAL CONDITIONS
- Temperature: 15-20 degrees Centigrade with animal room temperature exceeding the target range by up to 0.3 degrees Centigrade on five days. However, these excusions had no apparent effect on the health of the animals.
- Humidity: 30-70 % with animal room humidity exceeding the target range for more than two consecutive (4-hourly) recordings on eight days of the study. However, these excusions had no apparent effect on the health of the animals.
- Photoperiod: 12 hour day and 12 hour night provided by automatically controlled fluorescent lighting

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL of undiluted test material
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
3 males and 3 females
Details on study design:
Dorsal fur was removed using electric clippers on the day before dosing. Any rabbit with signs of damage or irritation of the dorsum was replaced. Undiluted test material was applied to the skin on a lint patch of 6 square centimetres, covered with gauze and held in place by an elastic adhesive bandage. After a 4 hour exposure the dressings were removed and the skin washed with water and dried.

After treatment the animals were examined for erythema, oedema and other dermal changes. Erythema and oedema were each scored on a five point scale (see Attachment A). The mean scores at each time point and group mean scores at 24, 48 and 72 hours were calculated.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 509M
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: 510M
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: 511M
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: 487F
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: 488F
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal: 489F
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: 509M
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal: 510M
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal: 511M
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal: 487F
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal: 488F
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal: 489F
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
A 4-hour semi-occluded topical application of the test substance to the clipped dorsal skin of six rabbits elicited very slight erythema from all areas of treated. Such reactions resolved within seven days of treatment.
Other effects:
No data

Applicant's summary and conclusion

Conclusions:
Semi-occluded topical application of the undiluted test material to the clipped dorsum of six rabbits for 4 hours caused irritation reactions not exceeding very slight erythema at all of the dermal test sites. The results were not sufficient to warrant classification for this endpoint.