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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: Comparable to guideline study with acceptable restrictions (mostly due to limited documentation before GLP)

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Fed. Reg. 38 No. 187 §1500.41
Deviations:
yes
Remarks:
(3 animals were tested - 6 animals were standard in the Draize test)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Naphthalimid fest (solid)
- Physical state: solid
- Analytical purity: < 99.5%

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gaukler
- Mean weight at study initiation: 3.2 kg

ENVIRONMENTAL CONDITIONS
not reported

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): presumably 0.5 g (derived from the guideline)
Duration of treatment / exposure:
presumably 24 h (derived from the guideline)
Observation period:
8 d
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 * 2.5 cm, back; intact and scarified sites were tested

REMOVAL OF TEST SUBSTANCE
presumably no (derived from the guideline)

SCORING SYSTEM: OECD Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
0.44
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
0.22
Max. score:
4
Reversibility:
fully reversible within: 48 h
Other effects:
Yellow substance residues were observed in one animal at the 24 h and 48 h readings.

Any other information on results incl. tables

Table 1. Results of skin irritation study.

Observation time

Rabbit no.

1

2

3

Erythema

Edema

Erythema

Edema

Erythema

Edema

24 h

1

0

1

0

2

2

48 h

0

0

0

0

0

0

72 h

0

0

0

0

0

0

4 d

0

0

0

0

0

0

7 d

0

0

0

0

0

0

8 d

0

0

0

0

0

0

Mean value 24 + 48 + 72 h

0,33

0,00

0,33

0,00

0,67

0,67

Mean value 24 + 48 + 72 h all animals

0,44

0,22

 

 

 

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information