Naphthalene-1,8-dicarboximide

Skin irritation / corrosion

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

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

Test material information

Constituent 1

Reference substance name:

Naphthalene-1,8-dicarboximide

EC Number:

201-379-7

EC Name:

Naphthalene-1,8-dicarboximide

Cas Number:

81-83-4

Molecular formula:

C12H7NO2

IUPAC Name:

3-azatricyclo[7.3.1.0⁵,¹³]trideca-1(13),5,7,9,11-pentaene-2,4-dione

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 or test system 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

Results

Results 1

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

Results 2

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