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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:
From 8th July 1981 to 11st July 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Test method is similar to OECD guideline 404. No GLP study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Physical state: a blue powder
Specific details on test material used for the study:
Lot/batch nº: 1

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS- Source: Recognised breeders whose premises have been inspected by Toxicol Laboratories- Weight at study initiation: 2.55-2.66 Kg- Housing: Grid bottomed galvanised metal cages- Diet (e.g. ad libitum): ninety to ninety five grams of a commercially available pelleted rabbit diet (Product Ref.16934, Spillers Agriculture Limited) for each animal at a similar time each day- Water (e.g. ad libitum): an automatic watering system provided a constant supply of drinking water to the cagesENVIRONMENTAL CONDITIONS- Temperature (°C): air -conditioned room- Photoperiod (hrs dark / hrs light): 14 hours light/10 hours dark per day

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
0,5g aliquots of the test material were moistened with 0,5ml sterile distilled water.
Duration of treatment / exposure:
24 hours
Observation period:
One hour was allowed to permit any irritation from the adhesive tapes 24 hour observation72 hour observation
Number of animals:
6
Details on study design:
TEST SITE-Area shaved: 10% of the total dorsal surface area. The left flank was then lightly abraded with the point of a 25x0.6mm sterile disposable hypodermic needle.-Area of exposure: 0.5g of the test sample was applied to each of two 2.5cm square surgical lint pads attached to "Sleek" plastic adhesive wrapping (one square with abraded skin and other square with intact skin)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No irritant/corrosive effects were noted
Other effects:
No general toxic effects were noted

Any other information on results incl. tables

No irritant/corrosive effects were noted

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance is considered as non-irritating to the skin.. The test material is not classify as a "primary irritant to the skin". It would be regarded as a mild irritant to the skin of the albino rabbit according to the Draize system of classification.
Executive summary:

The aim of this study was to investigate the degree of irritation produced to the abraded and intact skin of 6 albino rabbits following 24 hours occluded contact with the test material. The procedure used is that described in the U.S.Federal Register, 1973, Vol.38,No.187, Section 1500:41 (similar to OECD Guideline 404). 0.5 g of the test sample was applied to each of two 2.5cm square surgical lint pands attached to "Sleek" plastic adhesive wrapping. The duration of the exposure was 24 hours. Skin examinations were conducted at 24, 72h after patch removal. The average scores produced by the group of 6 rabbits were 0.0 for erythema and 0.0 for oedema, giving a primary irritation score of 0.0. No reactions were observed throught the study.

The test substance is considered as non-irritating to the skin.