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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: see 'Remark'
Remarks:
The study was conducted in a contract research organization according to internationally accepted technical guidelines then at force, but without QA-statement. The study is scientifically valid and, despite limited documentation, fully adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(of 1981)
Deviations:
no
Qualifier:
according to
Guideline:
other: Appraisal of Chemicals in Food, Drugs and Cosmetics. The Association of Food and Drug Officials of the United States.
Deviations:
not specified
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: adult
- Weight at study initiation: 3.0 kg (average weight)
- Housing: individual cages
- Diet: standard laboratory diet for rabbits, Altromin, Lage, Germany)
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 2°C
- Humidity (%):50-60
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
5
Details on study design:
TEST SITE
- Area of exposure: approx. 6 cm2 (gauze patches of 2.5 x 2.5 cm, fixed with adhesive plaster)

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 hours

TIME POINTS OF SKIN EVALUATION
- 1, 24, 48 and 72 h and 7 days post patch removal

SCORING SYSTEM:
According to Draize 1959 (“Dermal toxicity,” Appraisal of Chemicals in Food, Drugs and Cosmetics. The Association of Food and Drug Officials of the United States):
Erythema and formation of scabs:
Score 0: No erythema
Score 1: Slight erythema (scarcely visible)
Score 2: Erythema clearly visible
Score 3: Moderate to significant erythema
Score 4: Severe erythema (red purple) with formation of slight scabs (deep lesions)

Formation of oedema:
Score 0: No oedema
Score 1: Very slight oedema (scarcely visible)
Score 2: Slight oedema (well defined outlines, swelling apparent)
Score 3: Moderate oedema (thickness about 1 mm)
Score 4: Severe oedema (thickness more than 1 mm and area larger than the treated skin square)

Only differences from controls were considered to be positive reactions.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
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 effects
Other effects:
No effects on mortality or clinical signs were reported.

Any other information on results incl. tables

Scoring of Erythema and Oedema Formation

Time point

  1 h

  24 h

  48 h

  72 h

  7 d

Animal No

1

2

3

4

5

1

2

3

4

5

1

2

3

4

5

1

2

3

4

5

1

2

3

4

5

Erythema

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Oedema

0

0

0

0

0

0

0

0

0

0

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:
Under the conditions of the present experiment the test material was found to cause no irritation when applied to intact rabbit skin.