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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:
Test procedure in accordance with national standard methods with acceptable restrictions, study well documented; significance limited due to substance-induced coloration of the skin, which didn't allow correct reading of skin reactions; skin reactions could be caused by other components of the product (acetic acid).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Principles of method if other than guideline:
Method: Draize Test
according to: Federal Register 38, No. 187, §1500.41, p.27019 of Sep 27, 1973
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): fluessig

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: female: 3.1 kg/ male: 3.2 kg

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
no
Duration of treatment / exposure:
24 hour(s)
Observation period:
8 days
Number of animals:
6 (4 male/2 female)
Details on study design:
The undiluted test substance was applied to a 2.5 x 2.5 cm patch (0.5 ml) .

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24h, 72h
Score:
4
Reversibility:
not reversible
Remarks on result:
other: short observation period (8 days)
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24h, 72h
Score:
1.83 - 2.17
Reversibility:
not reversible
Remarks on result:
other: short observation period (8 days)

Any other information on results incl. tables

SKIN FINDINGS AFTER 24 AND 72 HOURS:

 

Skin

Time

Animal No.

1

2

3

4

5

6

Erythema

Intact

24 h

*

*

*

*

*

*

72 h

*

*

*

4

*

*

Abraded

24 h

*

*

*

*

*

*

72 h

*

4

*

*

*

*

Edema

Intact

24 h

2

2

2

2

3

2

72 h

2

2

2

0

3

2

Abraded

24 h

3

3

3

3

3

3

72 h

3

3

3

3

3

2

* The irritation index could not be calculated exactly due to substance-induced coloration of the skin. Primary irrition index of the skin: 17.83/4 = 4.46.

 

SKIN FINDINGS AFTER 8 DAYS:

Animal No.

Inctact

Abraded

 1

Scaling

Superficial necrosis with crusts

 2

Severe scaling

Superficial necrosis with crusts

 3

Erythema +, spotted

Superficial necrosis with crusts

 4

Superficial necrosis with crusts

Superficial necrosis with crusts

 5

Superficial necrosis with crusts

Superficial necrosis with crusts

 6

Superficial necrosis with crusts

Necrosis with crusts

Individual scores for erythema could not be determined due to substance-induced coloration of the skin. The mean edema score (24, 72 h) was 1.3 in 1 of 6 animals, 2.0 in 4 of 6 animals and 3.0 in 1 of 6 animals. At the end of the observation period (day 8) scaling (in 2 animals) or superficial necrosis with crusts (in 3 animals) was observed. Only cutaneous effects observed after treatment of intact skin are considered relevant for hazard assessment and are described in detail.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information