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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:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11
Version / remarks:
February 1965
GLP compliance:
no
Remarks:
pre GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 12-16 weeks.
- Weight at study initiation: average body weights of 2.80 males and 2.60 kg females.
- Housing: rabbits were caged singly.
- Diet: commercial irradiated diet (Styles-Oxoid), ad libitum.
- Water: sterile filtered water, ad libitum.
- Acclimation period: one week prior to the start of the trial.

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 1 °C
- Relative humidity: 50-70 %
- Photoperiod: animals were exposed to artificial light for 10 hours daily from 08.00 - 18.00 hours

Test system

Type of coverage:
occlusive
Preparation of test site:
other: intact shaved skin and abraded skin
Vehicle:
water
Controls:
yes
Amount / concentration applied:
10 g of the test compound was mixed with 10 ml of water to make a solution of 15 ml, 0.75 ml of which was applied to each test site on a 2.5 cm square gauze pad.
Duration of treatment / exposure:
24 hours
Observation period:
6 days
Number of animals:
3 males and 3 females
Details on study design:
TEST SITE
- Area of exposure: 24 hours prior to the dermal application, the backs of the rabbits were shaved. Two test sites lateral to the mid line of the back were used on each rabbit. Immediately before the application of the test compound, the right hand site was abraded uith the point of a sterile hypodermic needle. The abrasions were sufficiently deep to penetrate the stratum corneurn but not to damage the dermis. The left hand site remained intact.
- % coverage: area consisting of at least 10 % of the total body surface.
- Type of wrap if used: aluminium foil secured with "Sleek" adhesive tape. The test sites were then covered by a 6 wide "Coban" self adhesive bandage in order to retain the test substance in close contace with the skin.

SCORING SYSTEM
The assessment of the macroscopic skin reaction was made according to the following grading system:
Primary Irritation Score
0 Non irritating
0.1 - 0.5 Minimally irritating
0.6 - 1.5 Slightly irritating
1.6 - 3.0 Mildly irritating
3.1 - 5.0 Moderately irritating
5.1 . 6.5 Severely irritating
6.6 - 8.0 Extremely irritating

Erythema and Eschar Formation - Description
No erythema 0
Slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet red) to slight eschar formation 4

Oedema Formation - Description
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 mm.) 3.
Severe-oedema (raised more than 1 mm. and extending beyond the area of exposure) 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 6/6, both intact and abraded skin
Time point:
other: 24/72 hrs
Score:
< 2.3
Reversibility:
fully reversible within: 6 days
Irritation parameter:
edema score
Basis:
animal: 6/6, both intact and abraded skin
Time point:
other: 24/72 hrs
Score:
< 2.3
Reversibility:
fully reversible within: 6 days
Irritant / corrosive response data:
The primary irritation score was 1.8.
Slight to well defined erythema and wery slight to moderate oedema were seen on all rabbits 24 hours after application of the compound. By 72 hours there was only one abraded site still showing slight erythema and very slight oedema. This was normal by 6 days.
There was uery little difference in the reactions seen between abraded and intact sites.

Any other information on results incl. tables

Skin irritation reactions

N./sex Intact skin Abraded skin
24 hrs 72 hrs 6 days 24 hrs 72 hrs 6 days

Erythema

11M 1 0 0 2 0 0
13M 1 0 0 2 0 0
15M 1 0 0 1 0 0
12F 1 0 0 2 1 0
14F 1 0 0 2 0 0
16F 2 0 0 2 0 0
Mean 1.17 0.00 0.00 1.83 0.17 0.00

Oedema

11M 2 0 0 2 0 0
13M 2 0 0 2 0 0
15M 1 0 0 2 0 0
12F 2 0 0 3 1 0
14F 3 0 0 2 0 0
16F 1 0 0 1 0 0
Mean 1.83 0.00 0.00 2.00 0.17 0.00

Applicant's summary and conclusion

Conclusions:
Mild irritating
Executive summary:

Method

The skin irritation was determined in an irritation test on rabbits according the "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965)., similar to OECD guideline 404.

Result

The primary irritation score was 1.8.

Mild irritating