16,17-dimethoxyviolanthrene-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:

1975

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:

1975

Report date:

1975

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: Consumer Product Safety Commission of the U.S.A. in The Code of Federal Regulations, Title 16, Section 1500.4

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

Code of Federal Regulations, Title 16, Section 1500.41.
Primary irritation to the skin is measured by a patch test technique on the abraded and intact skin of the albino rabbit, clipped Free of heir. A minimum of six subjects are used in abraded and intact skin tests. Introduce under a square patch such as surgical gauze measuring 1 inch x 1 inch, two single layers thick, 0.5 milliliter (in case of Liquids ) or 0.5 gram ( in case of solids and semisolids ) of the test substance. Dissolve solids in an appropriate solvent and apply the solution as for liquids. The animals are immobilized with patches secured in place by adhesive tape. The entire trunk of the animal is then wrapped with an impervious material such as rubberized cloth for the 24-hour period of exposure. This material aids in maintaining the test patches in position and retards the evaporation of volatile substances. After 24 hours exposure, the patches are removed and the resulting reactions are evaluated on the basis of the Draize scores.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

16,17-dimethoxyviolanthrene-5,10-dione

EC Number:

204-896-6

EC Name:

16,17-dimethoxyviolanthrene-5,10-dione

Cas Number:

128-58-5

Molecular formula:

C36H20O4

IUPAC Name:

16,17-dimethoxyviolanthrene-5,10-dione

Test material form:

solid: granular

Details on test material:

Caledon Green XBN Grains

Test animals

Species:

rabbit

Strain:

other: albino

Test system

Type of coverage:

occlusive

Preparation of test site:

other: abraded (3x3 cm) and shaved (3x3 cm) skin

Vehicle:

unchanged (no vehicle)

Remarks:

pasted

Amount / concentration applied:

5 g

Duration of treatment / exposure:

24 hours

Observation period:

up to 72 hours

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure shaved and scarified skin: 2.5x2.5 cm
- Area of exposure shaved skin: 2.5x2.5 cm
- Type of wrap if used: 6 to 8 cm wide PVC sheeting covered by elastic bandage


REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours


SCORING SYSTEM: Code of Federal Regulations, Title 16, Section 1500.41

Erythema and eschar formation (EEF) : Value*
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

Edema formation (EF):
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 exp.) 4

*The "value" recorded for each reading is the average value of the six or more animals subject to the test.

Readings are again mode at the end of a total of 72 hours (48 hours after the first reading). An equal number of exposures are mode an areas of skin that have been previously abraded. The abrasions are minor incisions through the stratum corneum, but not sufficiently deep to disturb the derma or to produce bleeding. Evaluate the reactions of the abraded skin at 24 hours and at 72 hours, as described in this paragraph. Add the values for erythema and eschar formation at 24 hours and 72 hours for intact skin to the values an abraded skin at 24 hours and 72 hours (four values). Similarly, add the values for oedema formation at 24 hours and at 72 hours for intact and abraded skin (four values). The total of the eight values is divided by four to give the primary irritation score.

Primary Irritation Index (PII) = EEF24h-abraded + EEF72h-abraded + EEF24h-shaved + EEF72h-shaved + EF24h-abraded + EF72h-abraded + EF24h-shaved + EF72h-shaved / 4

ECLASSIFICATION SYSTEM FOR PRIMARY IRRITATION
From “Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics",
published by the Association of Food and Drug Officials of the United States, 1959, page 46.
"Compounds producing combined averages (primary irritation indices) of 2 or less are only mildly irritating; whereas those with indices from 2 to 5 are moderate irritants, and those with scares above 6 are considered severe irritants."

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24 + 72 h

Score:

0.01

Max. score:

8

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

erythema score

Remarks:

shaved skin

Basis:

mean

Time point:

other: 24/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

edema score

Remarks:

shaved skin

Basis:

mean

Time point:

other: 24/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Very slight erythema with very slight oedema was observed in one abraded site at the 24 hours reading.
Five animals did not show any observable response to treatment throughout the 72 hours observation period.
The primary Irritation was calculated to be : 0.1

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

not irritating