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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 October 1988 to October 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Mellor rabbits, chadderton heights, Chadderton, UK
- Age at study initiation: young adults
- Weight at study initiation: Rabbits weighed 3450 - 4131 g
- Housing: Housed indvidually in anodised aluminium sheet cages (65.2 cm width × 68.9 cm depth × 45.7 cm height), floor of the each cage was made of perforated aluminium sheet and the door was made of stainles stell rods.
- Temperature: 17 ± 20˚C
- Relative humidity: 55 ± 15%
- Air changes: 20-30 air changes per hour
- Photoperiod: 12 h of artificial light and 12 h darkness
- Acclimitisation period: 6 d prior to study

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
other: Deionised water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
approximately 500 mg of the test substance wetted with 0.6 mL of deionised water
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3
Details on study design:
3 male rabbits were used for this study, approximately 24 h before the application of the test substance, the hair was removed from an area approximately 7cm X 13 cm on the left flank of each animal with a pair of veterinary clippers. Only animals in which the epidermis appeared to be normal on gross observation immediately after clipping were used. Each animal was given a number, unique within the study, which was written both on the inner side of the ear, using the black waterproof marker-pen, and on the cage card. The body weight of each animal, at the end of the study was recorded.

Test substance approximately 500 mg was moistened with a small amount (0.6 mL) of deionised water and applied to the test site (approximately size 2.5 cm X 2.5 cm 8 ply) which was secured by two crossed strips of surgical tape (approximately 1 cm X 8 cm). This was covered by a piece of impermeable rubber sheeting (approximately size 35 cm X 13 cm) wrapped once around the trunk of the animal and secured with adhesive impermeable polyethylene tape (7.5 mm wide).

The dressing was left in position for approximately 4 h. After this time each dressing was carefully cut, removed and discarded. The application site was gently cleansed free of any residual test sample using clean swabs of absorbent cotton wool soaked in clean warm water and was then dried gently with clean tissue paper. The application site was identified using a black waterproof marker-pen.

The Draize scale was used to assess the degree of erythema and enema at the application site approximately 30 - 60 minutes. 1, 2 and 3 d after removal of the dressings. Any other signs of skin irritation were also noted.

A mean erythema score was calculated for each animal by adding together the erythema score at the 1,2 and 3 readings and dividing the total by three. A mean oedema score was calculated in a similar manner.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No significant signs of irritation were found.

Any other information on results incl. tables

Following a single 4 h application of test substance, very slight erythema was seen for up to 2 d after the decantation and very slight oedema was seen immediately after decantation in one animal. Staining was seen in the application sites of the other two animals but this did not obscure the reading of the sites. No signs of skin irritation were seen in these two animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, the substance was not irritating to rabbit skin.
Executive summary:

A study was conducted to determine the in vivo skin irritation / corrosion potential of the test substance according to OECD Guideline 404, in compliance with GLP. Three New Zealand rabbits were exposed for 4 h to 500 mg of substance moistened with water. The experiment consisted in the occlusive coverage of clipped skin free of fur. Following application, animals were observed after 1, 24, 48 and 72 h. Under the study conditions, the substance was not irritating to rabbit skin (Robinson, 1989).