Trisodium 1-amino-4-[[3-[[4-chloro-6-[(sulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]-2,4,6-trimethyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1984

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

study predates GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium 1-amino-4-[[3-[[4-chloro-6-[(sulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]-2,4,6-trimethyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

EC Number:

276-481-8

EC Name:

Trisodium 1-amino-4-[[3-[[4-chloro-6-[(sulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]-2,4,6-trimethyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

Cas Number:

72214-18-7

Molecular formula:

C32H26ClN7O11S3.3Na

IUPAC Name:

hexasodium 1-amino-4-{[3-({4-chloro-6-[(3-sulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)-2,4,6-trimethyl-5-sulfonatophenyl]amino}-9,10-dioxo-9,10-dihydroanthracene-2-sulfonate 1-amino-4-{[3-({4-chloro-6-[(4-sulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)-2,4,6-trimethyl-5-sulfonatophenyl]amino}-9,10-dioxo-9,10-dihydroanthracene-2-sulfonate

Test material form:

other: Granulate

Details on test material:

None

Specific details on test material used for the study:

Company code: FAT 41001/D
Batch No: EN 94060.32
Purity: 78.8 %
Appearance: Granulate
Stability of the test compound: until November 1988
pH-value: 7.6 (lg/1 water)
Test article received: December 6, 1983

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation:12 - 14 weeks
- Weight at study initiation: 2000-2260 g
- Housing: Animals were housed individually in metal cages.
- Diet (e.g. ad libitum): Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland), ad libitum.
- Water (e.g. ad libitum): Water were provided ad libitum.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Air changes (per hr): approximately 15 air changes/h
- Photoperiod (hrs dark / hrs light): 12 hours light/day

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

1. 24, 48, 72 hours

Number of animals:

3 females

Details on study design:

SCORING SYSTEM:
After removal of the dressings the skin reaction was assessed on the basis of an evaluation scheme, (cf. Table 1), after 1, 24, 48, 72 hours and during the following observation period. The score obtained is defined as the "index of primary cutaneous irritation".

INDEX CLASSIFICATION
<0.5 non irritant
0.6 - 3.0 slightly irritant
3.1 - 5.0 irritant
5.1 - 8.0 severely irritant

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

Oedema formation:
- No oedema: 0
- Very slight oedema (barely perceptible): 1
- Slight oedema (edges of area well defined by definite raising): 2
- Moderate oedema (raised approximately 1 millimeter): 3
- Severe oedema (raised more than 1 millimeter and extending beyond the area of' exposure): 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48h

Remarks on result:

other: only 1 animal could beassessed due to strong colouring of the skin

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

The animals showed a normal body weight development. Starred figures indicate impossibility of scoring due to intensive blue staining by the test compound. The scoring was performed after the values for edema only.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 41001/D is non-irritant and not corrosive when applied to the rabbit skin; the test was terminated after 3 observation days.

Executive summary:

The purpose of this study was to evaluate the primary skin irritation in Albino rabbits with compound FAT 41001/D. The test was carried out according to OECD guideline 404. Not less than 24 hours before treatment on the back of the experimental animal an area was shaven of at least 6 sq.cm by means of an electric clipper. 0.5 ml of the test substance was applied to the skin by means of gauze and loosely held in place by adhesive but non irritating tape for a period of 4 hours. Erythema scoring was possible only in one animal since intensive staining was observed in other animals. The mean 24/48/72h score was recorded to be 0.33 for animal #1. The mean 24/48/72h oedema score was recorded to be 0. The animals showed a normal body weight development. No other reactions to treatment were recorded during the whole observation period. Based on the findings of the study, it can be concluded, that FAT 41001/D is non-irritant and not corrosive when applied to the rabbit skin. The test was terminated after 3 observation days.