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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions Lack of details in study documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Lack of details in study documentation
Principles of method if other than guideline:
Application of 0.5 ml to an area of approx. 2.5 cm x 2.5 cm.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
No Data

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
No Data

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
not specified
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml
- Concentration (if solution): No Data
Duration of treatment / exposure:
4 h
Observation period:
12 d
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm² on the shorn left flank (dorso-lumbar region)
- Type of wrap if used: semi-occlusive


REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water upon the removal of the dressing
- Time after start of exposure:4 h


SCORING SYSTEM: Draize scale

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of animal #15 and readings at
Time point:
other: 24 h, 48 h and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 12 d
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of animal #16 and readings at
Time point:
other: 24 h, 48 h and 72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 11 d
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of animal #17 and readings at
Time point:
other: 24 h, 48 h and 72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
edema score
Basis:
mean
Remarks:
of animal #15 and readings at
Time point:
other: 24 h, 48 h and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
edema score
Basis:
mean
Remarks:
of animal #16 and readings at
Time point:
other: 24 h, 48 h and 72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
edema score
Basis:
mean
Remarks:
of animal #17 and readings at
Time point:
other: 24 h, 48 h and 72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritant / corrosive response data:
Following the single 4-hour application, a very slight to well-defined erythema and very slight to slight oedema were observed. This regressed and no signs of erythema or oedema were evident eleven or twelve days after application. Slight desquamation at the application site of one animal was observed seven days after application.

Any other information on results incl. tables

Erythema score

Animal Number

1 h

24 h

48 h

72 h

7 days

11 days

12 days

Mean Score

15

2

-

1

1

1

 

0

1.0

16

2

2

1

1

1

0

 

1.3

17

1

2

1

1

0

 

 

1.3

 

Edema Score

Animal Number

1 h

24 h

48 h

72 h

7 days

11 days

12 days

Mean Score

15

1

-

1

1

0

 

0

1.0

16

2

2

2

1

0

0

 

1.7

17

1

2

2

1

0

 

 

1.7

Conclusion: The test substance does not have to be classified as irritant to the skin according to the criteria of the DSD and CLP regulations under the conditions of this study.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU