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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: limited documentation and sone deviations to OECD 404. The study is however sufficient for evaluation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Principles of method if other than guideline:
2 rabbits were treated for 1, 5 and 15 minutes and for 20 hours using occlusive conditions.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Chlorameisensäure methyl ester (chloroformic acid-methyl ester)
- Physical state: liquid
- no further data

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gaucler, Offenbach, Germeny
- Weight at study initiation: 2.72 kg (male); 2.40 kg (female)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
no data

Test system

Type of coverage:
occlusive
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): 0.5 ml
Duration of treatment / exposure:
1, 5 and 15 minutes and 20 hours
Observation period:
8 days
Number of animals:
4
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): 50 % Lutrol (mild detergent solution)
- Time after start of exposure: 1, 5 and 15 minutes and 20 hours

SCORING SYSTEM:
descriptive scoring system comparable to the Draize score

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 h
Score:
6
Max. score:
8
Remarks on result:
other: necrocis
Irritant / corrosive response data:
full thicness necrosis was observed

Any other information on results incl. tables

Since irritation data are recommended for a 4 h skin exposition, results of the available 20 h and the 15 min exposition will serve as approximation.

Descriptive scores of the raw data have been converted to Draize numerical scores.Erythema scoring was at the border of the necrotic aerea.

Exposition:

20 h

Animal

Reading

Erythema

Edema

Comment

3

24 h

3

3

necrosis

4

24 h

3

3

necrosis

3

48 h

3

2

necrosis

4

48 h

3

3

necrosis

3

8 d

0

0

severe necrosis

4

8 d

0

0

severe necrosis

mean

24 - 48 h

3.0

2.75

 

 

 

 

 

 

Exposition:

15 min

Animal

Reading

Erythema

Edema

Comment

1

24 h

3

3

necrosis

2

24 h

2

4

necrosis

1

48 h

3

3

necrosis

2

48 h

2

3

necrosis

1

8 d

0

0

severe necrosis

2

8 d

0

0

severe necrosis

mean

24 - 72 h

2.5

3.25

 

Exposition:

5 min

Animal

Reading

Erythema

Edema

Comment

1

24 h

3

3

necrosis

2

24 h

3

3

necrosis

1

48 h

3

2

necrosis

2

48 h

3

3

necrosis

1

8 d

0

0

severe necrosis

2

8 d

0

0

severe necrosis

mean

24 - 72 h

3.0

2.75

 

 

 

 

 

 

Exposition:

1 min

Animal

Reading

Erythema

Edema

Comment

1

24 h

3

3

necrosis

2

24 h

3

3

necrosis

1

48 h

3

2

necrosis

2

48 h

3

3

necrosis

1

8 d

0

0

severe necrosis

2

8 d

0

0

severe necrosis

mean

24 - 72 h

3.0

2.75

 

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information