Violanthrene-5,10-dione

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: “Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965)

Version / remarks:

1965

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Violanthrene-5,10-dione

EC Number:

204-152-0

EC Name:

Violanthrene-5,10-dione

Cas Number:

116-71-2

Molecular formula:

C34H16O2

IUPAC Name:

violanthrene-5,10-dione

Test material form:

solid: particulate/powder

Details on test material:

Vat Blue 20

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
Healthy New Zealand White rabbits (Porton- strain) aged 11-12 weeks with average body weights of 2.57 kg (males) and 2.19 Kgs. (femals), bred on the premises and maintained under a semi-barrier system. Six rabbits (3 males and 3 females) were acclimatized in the test area for one week prior to the start of the study.

ENVIRONMENTAL CONDITIONS
The rabbits were caged singly in. an experimental room maintained at a temperature of 20°C (± 1) and a relative humidity of 50-70%. Animals were exposed to artificial light for 10 hours daily from 08.00 18.00 hours. A commercial irradiated diet (Styles-Oxoid) was fed ad libitum. Sterile filtered water was available at all times.

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved and slightly scarified

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

24 hours

Observation period:

14 days

Number of animals:

3 males and 3 females

Details on study design:

The test was carried out according to the method given in the “Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965).
Twenty-tour hours prior to the dermal application, the backs of the rabbits were shaved over an area consisting of at least 10% of the total body surface. Two test sites lateral to the mid line of the back were used an each rabbit. Immediately before the application of the test compound, the right hand site was abraded with the point of a sterile hypodermic needle. The abrasions were sufficiently deep to penetrate the stratum corneum but not to damage the dermis. The left hand site remained intact.
10 g of the test compound was mixed with 10 ml of water to make a suspension of 20 ml, 1.0 ml of which was applied each test site on a 2.5 cm square gauze pad. These were covered with aluminium foil secured with "Sleek" adhesive tape. The test sites were then covered by a 6" wide "Coban” self adhesive bandage in order to retain the test substance in dose contact with the skin.
After 24 hours the dressing was removed and the intact and abraded application sites were assessed for oedema and erythema. A further assessment was made at 72 hours and for any further period considered necessary up to 14 days.
The assessment of the macroscopic skin reaction was made according to the following grading system:

Score for skin irritation in rabbits (evaluation scheme)
Erythema and eschar formation
- No erythema: 0
- Very slight erythema (barely perceptible): 1
- Well defined erythema: 2
- Moderate to severe erythema: 3
- Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4
Total possible erythema score: 4

Edema formation
- No edema: 0
- Very slight edema (barely perceptible): 1
- Slight edema (edges of area well defined by definite raising): 2
- Moderate edema (raised approximately 1 mm): 3
- Severe edema (raised more than 1 mm and extending beyond area of exposure): 4
Total possible edema score: 4

Primary Irritation Score
0 Non irritating
0.1 - 0.5 Minimally irritating
0.6 - 1.5 Slightly irritating
1.6 - 3.0 Mildly irritating
3.1 - 5.0 Moderately irritating
5.1 - 6.5 Severely irritating
6.6 - 8.0 Extremely irritating

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

other: The scores read after 24 and 72 hours for erythema and edema for the intact as well as for the abraded skin were summed up and divided by 4. (FHSLA § 191.11)

Time point:

other: 24/72 hours

Score:

1.5

Max. score:

8

Reversibility:

fully reversible

Remarks on result:

other: slightly irritating

Results 2

Irritation parameter:

edema score

Remarks:

shaved

Basis:

mean

Time point:

24 h

Score:

0.83

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

erythema score

Remarks:

shaved

Basis:

mean

Time point:

24 h

Score:

1.17

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

A slight to well-defined erythema and a very slight to slight oedema were seen an all rabbits 24 hours after application of the compound. By 72 hours all intact sites were normal but 4/6 abraded sites were still showing a slight reaction. These were normal by day 10. The primary Irritation score was 1.5.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

A slight to well-defined erythema and a very slight to slight oedema were seen an all rabbits 24 hours after application of the compound. By 72 hours all intact sites were normal but 4/6 abraded sites were still showing a slight reaction. These were normal by day 10. The primary Irritation score was 1.5.

According to GHS, the test substance is not irritating to skin.

Executive summary:

The skin irritation in albino rabbits after single application was performed to determine the irritant potency of the test item on the albino rabbit skin.The test was carried out according to the method given in the “Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965).

The test was performed on 3 male rabbits and 3 female rabbits (New Zealand White rabbits), checked for normal skin conditions. Before treatment, the flanks of the rabbits were shaved and immediately before treatment, the shaven skin on one side was slightly scarified. A gauze patch bearing 1 g of the test substance was applied to the prepared abraded and intact skin. The patches were covered by an impermeable material. Patches were held in place for 24 hours.

A slight to well-defined erythema and a very slight to slight oedema were seen an all rabbits 24 hours after application of the compound. By 72 hours all intact sites were normal but 4/6 abraded sites were still showing a slight reaction. These were normal by day 10. The primary Irritation score was 1.5.

According to the GHS evaluation system, the test substance is not irritating to skin.