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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:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Remarks:
Early study, but reporting the main relevant details, No GLP, short report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
other: The Food and Drug Administration of the U.S .A. in The Federal Regi5ter (17 September 1964 § 191 .11)
GLP compliance:
no
Remarks:
pre-dates GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
not specified

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
not required
Amount / concentration applied:
0,5 g of test substance was mixed to a paste in water before application
Duration of treatment / exposure:
24 h
Observation period:
72 hours
Number of animals:
6
Details on study design:
All animals were treated on intact skin (left) and on abraded skin (right)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
mean
Time point:
other: 24 h
Score:
0.5
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
mean
Time point:
other: 24 h
Score:
0.166
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritant / corrosive response data:
Only 3 of 6 animals showed slight erythema on intact skin and 1 of these additionally a slight edema.
Other effects:
None

Any other information on results incl. tables

Animal

Effect

24 h

72 h

Intact

intact

1

Erythema

0

0

 

Edema

0

0

2

Erythema

0

0

 

Edema

0

0

3

Erythema

1

0

 

Edema

1

0

4

Erythema

0

0

 

Edema

0

0

5

Erythema

1

0

 

Edema

0

0

6

Erythema

1

0

 

Edema

0

0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Findings were not sufficient to warrant classification under 1272/2008 CLP
Executive summary:

0.5 g of the test item was mixed to a paste in water before application to the skin.

RESULT

Very slight erythema with and without and very slight to slight oedema was observed in three intact and six abraded sites at the 24 hours reading and three abraded sites at the 72 hours reading.

Findings were not sufficient to warrant classification under 1272/2008 CLP