1,1'-diethyl[3,3'-bianthra[1,9-cd]pyrazole]-6,6'(1H,1'H)-dione

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

June 05, 1975

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

The study has been conducted according to procedures similar to the accepted guidelines but the content of the active ingredient in the substance composition is very low.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO).

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Vat Red 013

IUPAC Name:

Vat Red 013

Test material form:

not specified

Test animals

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Russian breed
- Weight at study initiation: 1.5 to 2 kg
- Housing: animalshoused individually in metal cages
- Diet (e.g. ad libitum): ad libitum standard rabbit food - NAFAG, Gossau SG
- Water (e.g. ad libitum): ad libitum
- Acclimation period: for a minimum of 8 days

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

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

not specified

Amount / concentration applied:

Not specified

Duration of treatment / exposure:

24 hours

Observation period:

after 24 and 72 hours

Number of animals:

3 males and 3 females

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm per side
- Type of wrap if used: gauze patch

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

OBSERVATION TIME POINTS
24 and 72 hours

SCORING SYSTEM:
Score for skin irritation in rabbits

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
Maximum 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
Maximum possible edema score 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Conclusions:

Not skin irritant

Executive summary:

The substance was tested according to the Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO), on 3 male and 3 female rabbits.

Under test condition the substance resulted to be not irritant to skin.