Trisodium 2-[[6-[(4-amino-6-chloro-1,3,5-triazin-2-yl)methylamino]-1-hydroxy-3-sulphonato-2-naphthyl]azo]naphthalene-1,5-disulphonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1983

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

None

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

None

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium 2-[[6-[(4-amino-6-chloro-1,3,5-triazin-2-yl)methylamino]-1-hydroxy-3-sulphonato-2-naphthyl]azo]naphthalene-1,5-disulphonate

EC Number:

274-700-1

EC Name:

Trisodium 2-[[6-[(4-amino-6-chloro-1,3,5-triazin-2-yl)methylamino]-1-hydroxy-3-sulphonato-2-naphthyl]azo]naphthalene-1,5-disulphonate

Cas Number:

70616-89-6

Molecular formula:

C24H18ClN7O10S3.3Na

IUPAC Name:

trisodium 2-({6-[(4-amino-6-chloro-1,3,5-triazin-2-yl)(methyl)amino]-1-hydroxy-3-sulfonato-2-naphthyl}azo)naphthalene-1,5-disulfonate

Test material form:

solid: particulate/powder

Details on test material:

Identity FAT 40170/E TEBatch Ref No. 6293 (India)Appearance red brown powder at 20°CSmell neutralpH-Value pH-value of a solution of 2% (w/w) = 6.2Expiration date October 14th, 2019Storage to be stored at room-temperature

Specific details on test material used for the study:

None

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: 2300-2600 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 ad libitum ENVIRONMENTAL CONDITIONS - Temperature (°C): 20±3° C - Humidity (%): 30-70 % - Air changes (per hr): 12 hours light/day - Photoperiod (hrs dark / hrs light): approximately 15 air changes/h.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

A gauze patch bearing 0.5 ml of the test substance was applied to the skin

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48, 72 hours

Number of animals:

3 males

Details on study design:

None

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

There was no observable response to treatment in any of the six animals at the 24 hours or the 72 hours readings .

Other effects:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 40170/B is to be considered as a non-irritant to the skin of rabbits.

Executive summary:

A study was performed to determine the acute irritation, provoked by the compound, FAT 40170, on the skin of the rabbits according to the OECD guidelines for testing of chemicals: Acute dermal Irritation/Corrosion No. 404, adopted May 12, 1981 by the OECD Council. 6 rabbits, Albino White breed, were shaved and the test substance applied on abraded and intact skin of the animals. A gauze patch bearing 0.5 g of the test substance was applied to the skin and loosely held in place by adhesive but non irritating tape (ISOPLAST AG, CH-5200 Brugg). The substance was water moistened before application. After removal of the dressings the skin reaction was assessed on the basis of an evaluation scheme, after 1, 24, 48, 72 hours and during the following observation period. There was no observable response to treatment in any of the six animals at the 24 hours or the 72 hours readings.Therefore FAT 40170/A is to be considered as a non-irritant to the skin of rabbits.