Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 03 to 06 May 1989
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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Batch No.: Not specified
Purity: ≥99.5%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga, Sulzfeld, West-Germany
- Age at study initiation: ±12 weeks
- Weight at study initiation: 2462-3094 gram
- Housing: Individually in cages with perforated floors equipped with an automatic drinking system
- Diet (e.g. ad libitum): Standard laboratory rabbit diet approx. 100 gram per day
- Water (e.g. ad libitum): Free access to tap-water diluted with decalcified water
- Acclimation period: At least five days under test conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±3℃
- Humidity (%): 30-70%
- Air changes (per hr): 7.5-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light/ 12 hours dark

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g
- Concentration (if solution):
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: Approximately 100 square centimeters (10 cm×10 cm)
- % coverage:
- Type of wrap if used: elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: One of three animals appeared very slight erythema.
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
The test substance resulted in a primary irritation index of 0 (non-irritation) when applied to intact rabbit skin.

The observed skin irritation consisted of very slight erythema in one animal. The irritation was reversible within 24 hours after exposure.

No corrosive effect was evident on the skin.
Other effects:
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Any other information on results incl. tables

Individual skin irritation scores

Time after exposure

Rabbit 2735

Rabbit 2736

Rabbit 2737

Erythema

Oedema

Erythema

Oedema

Erythema

Oedema

1 hour

24 hours

48 hours

72 hours

0

0

0

0

0

0

0

0

1

0

0

0

0

0

0

0

0

0

0

0

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:
The test substance is not irritating when applied to the intact rabbit skin.
Executive summary:

This study was conducted under GLP according to OECD 404. Three rabbits were exposed to 0.5 g of the test substance, moistened with water, by application onto clipped skin for 4 hours using a semi-occlusive dressing. Skin reactions were assessed at 1, 24, 48 and 72 hours after the removal of the dressings and test article.

Under the conditions of this study, the test substance resulted in a primary irritation index of 0 when applied to the intact rabbit skin. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred. In conclusion, the test substance is not irritating when applied to the intact rabbit skin.

The study represents a worst case situation as the treated skin area was 100 cm2 instead of 6 cm2 as required by the present version of OECD 404.