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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted similar to OECD guideline 404. However some deviations occurred (e.g. 24 h occluded exposure, limited data on test substance).

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
other: Draize test
Deviations:
yes
Remarks:
e.g. 24 h occluded exposure, limited data on test substance
Qualifier:
according to
Guideline:
other: patch-test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO)
Deviations:
no
GLP compliance:
no
Remarks:
Study was conducted prior to implementation of GLP.

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
other: Russian
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.0 to 2.3 kg
- Housing: Individually in metal cages
- Diet (ad libitum): Standard rabbit food - NAFAG Gossau SG
- Water (ad libitum)
- Acclimation period: At least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18±1
- Humidity (%): 55±5
- Photoperiod (hrs dark / hrs light): 10/14

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
24 h
Observation period:
7 d
Number of animals:
3 males and 3 females

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 6 animals
Time point:
24/48/72 h
Score:
0.61
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 6 animals
Time point:
24/48/72 h
Score:
0.22
Max. score:
4
Reversibility:
fully reversible within: 48 h

Any other information on results incl. tables

Table 1: Details on results

Observation time

Rabbit No.

1

2

3

4

5

6

er

ed

er

ed

er

ed

er

ed

er

ed

er

ed

24 h

1

0

1

0

1

1

1

1

2

1

1

1

48 h

1

0

1

0

0

0

0

0

1

0

1

0

72 h

0

0

0

0

0

0

0

0

0

0

0

0

Mean value

24 + 48 + 72 h

0.67

0

0.67

0

0.33

0.33

0.33

0.33

1.0

0.33

0.67

0.33

Mean value

24 + 48 + 72 h,

all animals

0.61

0.22

 

 

 

 

 

 

 

 

 

 

er: erythema, ed: edema

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified