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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:
2 Oct - 24 Oct 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study (OECD) with some divations, since the test substance was not characterized in detail.

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)
Version / remarks:
directive 84/449/EWG, 19. Sept, 1984
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: yellow brownish, oily liquid
- Analytical purity: not specified

Test animals

Species:
rabbit
Strain:
other: Kleinrusse, Chbb: HM
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Fa. Thomae, Biberach, Germany
- Age at study initiation: 10-11 months
- Weight at study initiation: mean: 2550 g
- Housing: single in rabbit batteries
- Diet: Altromin Haltungsdiät 2023, Fa. Altromin, Lage, Germany, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least a week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 45-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated sites of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:
4 hours
Observation period:
21 days
reading time points: 1, 24, 48, 72 hours, 7, 14 and 21 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm² on the back
- Type of wrap if used: air and water vapor permeable paving fixed with a hypoallergen bandage

SCORING SYSTEM: Draize Scoring System

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 hours
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 hours
Score:
3.67
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 hours
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
edema score
Basis:
other: mean over animal#1 - animal#3
Time point:
other: mean over 24, 48 and 72 hours
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: scabs were seen at application site starting at 24 hours
Irritant / corrosive response data:
Severe redness (score 3-4) and edema (score 3-4) were observed up to the 72 hour reading time point. Effects were not completely reversible until Day 21 and on Day 21 at the end of the observation period one animal still showed erythema (score 3) and the other 2 animals slight erythema (score 1). No edema was seen anymore but all animals showed scar tissue.
Other effects:
Scabs were also seen already 24 hours after removal of the test substance. Additionally brownish coloring of the application site was observed at the 72 h reading time point. At Day 21 all animals showed scabs and scar tissue.

Any other information on results incl. tables

Table 1. Results of skin irritation study.

Observation time

Rabbit no.

1

2

3

Erythema

Edema

Erythema

Edema

Erythema

Edema

1 h

4

3

3

3

3

3

24 h

4

3S

3

3S

4

3S

48 h

4

3S

4

3S

4

3S

72 h

4b

3S

4b

3S

4b

3S

21 days

3

0S

1

0S

1

0S

Mean value 24 + 48 + 72 h

4

3

3.67

3

4

3

Mean value 24 + 48 + 72 h all animals

3.89

3

 

 

 

 

S = scabs, b = brownish staining

Applicant's summary and conclusion

Interpretation of results:
corrosive
Conclusions:
DSD: C, R34
CLP: Category 1C, H314