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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 11 Aug, 1993 to 14 Aug, 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

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

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Three healthy adult rabbits of the New Zealand White strain were obtained from Froxfield (U .K.) Ltd., Petersfield, Hampshire, England.
- Age at study initiation: 10 to 11 weeks
- Weight at study initiation: 2.2 to 2.6 kg
- Housing: Housed individually in metal cages with perforated floors in buliding R 14 room 5
- Diet: Ad libitum, satndard laboratory diet SDS stanrab (P) rabbit diet
- Water: Ad libitum, routine chemical examination of drinking water at source was conducted usually weekly by the supplier
- Acclimation period: Yes

ENVIRONMENTAL CONDITIONS
- Temperature: 19°C
- Humidity: 30 to 70%
- Air changes: 19 changes/h
- Photoperiod: 12 h of artificial light (0700 - 1900 h) in each 24 h period.

Each animal was identified by a numbered aluminium tag placed through the edge of one ear.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 mL undiluted
Duration of treatment / exposure:
4 h
Observation period:
Observations were made 1, 24, 48 and 72 h after exposure.
Number of animals:
3
Details on study design:
-Treatment: 24 h before treatment, the dorso-lumber region was clipped with electric clippers, exposing an area of approx 100 mm x 100 mm.
- Each animal was treated by dermal application of 0.5 mL of the test substance. The test substance was applied under a 25 mm x 25 mm gauze pad to one intact site on each animal. Each site was covered with elastoplast adhesive dressing for 4 h. The animals were not restrained during the exposure period.
- At the end of exposure the semi-occlusive dressing was removed and the site was washed with warm water to remove any residual test substance and blotted dry with absorbent paper.

-Observation:
Clinical signs: Daily.
Dermal responses: The skin reactions were assessed at approx 1, 24, 48 and 72 h after the removal of the dressings and test substance.The irritation scores and a description of all other (local) effects were recorded.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: No effects were observed
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: No effects were observed
Irritant / corrosive response data:
No dermal response (erythema or edema) were observed in any animal throughout the observation period
Other effects:
No signs of toxicity or ill health in any rabbit was seen during the observation period.

Any other information on results incl. tables

Results:

Rabbit number and sex

24, 48 and 72 h (erythema and edema scores)

2271-female

0

2272-female

0

2273-female

0

 

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
Under the test conditions, di-TMPTTA was considered to be non irritating to rabbit skin.
Executive summary:

A study was performed to evaluate the skin irritation potential of di-TMPTTA according to EU Method B.4, in compliance with GLP. Three rabbits were exposed to 0.5 mL of undiluted test substance, applied onto clipped skin for 4 h using a semi-occlusive dressing. Observations were made 1, 24, 48 and 72 h after removal of the dressing. Exposure to the test substance did not result in any dermal irritation in the form of erythema or edema. Under the test conditions, the substance was considered to be non-irritating to rabbit skin (Parcell, 1993).