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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: According to OECD 404. GLP study. The dose level applied to the skin of the animals was 250 mg instead of 500 mg for solids, as recommended in the guideline. However, it is considered that this deviation does not affect the outcome of the study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
(However, it is considered that this deviation does not affect the outcome of the study).
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: Pale yellow powder
- Analytical purity: 99.04%
- Lot/batch No.: 5/87; Indent 9200/9622
- Storage condition of test material: Following its arrival in Compound Control this test substance was stored in the dark at ambient temperature.
- Stability: Infra-red spectra of the test substance were taken. There were no significant differences between the spectra and so, on this basis, the test substance was judged to have been stable for the duration of this study.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Sittingbourne Research Centre Breeding unit
- Age at study initiation: 4-9 months old
- Weight at study initiation: males: 3888-4462 g; females: 4966-4994 g
- Housing: Animals were singly housed in hanging, stainless-steel cages with all-mesh floors and tops and half-mesh fronts; each cage measured 67 cm x 43 cm x 45 cm.
- Diet (e.g. ad libitum): Standard Rabbit Diet, S.Q.C., Special Diet Services Ltd., Essex, ad libitum.
- Water (e.g. ad libitum): Filtered from the public supply , ad libitum.
- Acclimation period: At least, two weeks.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-19 ºC
- Humidity (%): Not documented.
- Air changes (per hr): Not documented.
- Photoperiod (hrs dark / hrs light): Lighting was automatically switched on for the day (06.00 to 18.00 hours GMT) and off for the night (18.00 to 06.00 hours GMT).


Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: moistened with water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 250 mg
Duration of treatment / exposure:
4 hours
Observation period:
30 minutes after the removal of the patch and at 24, 48 and 72 hours and 7 days after patch removal.
Number of animals:
Three per sex
Details on study design:
TEST SITE
- Area of exposure: Dorsal hair between the shoulders and hindquarters was closely shorn with fine electric clippers. A 2 cm x 2 cm lint patch was applied.
- Type of wrap if used: The patch and surrounding skin were covered by a single layer of gauze and held in place by means of an elastic adhesive bandage.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): After 4 hours the wrapping and patch were removed and the test site washed with water and gently dried.


SCORING SYSTEM: Erythema and oedema on a graded scale of 0 to 4.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-72 h
Score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-72 h
Score:
0

Any other information on results incl. tables

Table 7.3.1: Dermal irritation scores

Erythema

Oedema

Animal No

1

2

3

4

5

6

1

2

3

4

5

6

after 4 h

0

0

0

0

0

0

0

0

0

0

0

0

after 24 h

0

0

0

0

0

0

0

0

0

0

0

0

after 48 h

0

0

0

0

0

0

0

0

0

0

0

0

after 72 h

0

0

0

0

0

0

0

0

0

0

0

0

after 7 days

0

0

0

0

0

0

0

0

0

0

0

0

Mean score 24 – 72 h

0.0

0.0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In the 4 hour rabbit skin irritancy test, the test material caused no skin reactions and is therefore not a skin irritant.
Executive summary:

Six New Zealand White rabbits (3 per sex) were exposed via the dermal route to 250 mg of the test substance. After a 4 hour exposure the dresssings were removed, the skin washed with water and dried. After treatment, animals were examined for erythema, oedema and other lesions at 4, 24, 48 and 72 hours and at 7 days after patch removal. The test material caused no skin reactions and was therefore considered as not irritanting to skin.