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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

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:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

None

GLP compliance:

no

Test type:

standard acute method

Limit test:

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:

rat

Strain:

other: Tif:RAIf(SPF)

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland- Age at study initiation: 7-8 weeks- Weight at study initiation: 160-215 g- Housing: Macrolon cages type 4- Diet (e.g. ad libitum): Rat food, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland),- Water (e.g. ad libitum): water ad libitum ENVIRONMENTAL CONDITIONS - Temperature (°C): 22+3° C - Humidity (%): 55±15% - Air changes (per hr): 15 air changes/h - Photoperiod (hrs dark / hrs light): 12 hours light/day

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

None

Doses:

2000, 5000 mg/kg bw.

No. of animals per sex per dose:

5 males and 5 females per dose level

Control animals:

not specified

Details on study design:

None

Statistics:

None

Results and discussion

Preliminary study:

None

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed with the dose of 2000 mg/kg bw, however 1 male out of 5 and 3 females out of 5 were found dead on Day 1 with the dose of 5000 mg/kg bw.

Clinical signs:

other: Dyspnoea, exophthalmos, ruffled fur and curved body position were seen, being common symptoms in acute tests. In addition, sedation and diarrhea was observed.

Gross pathology:

None

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral median lethal dose (LD50) of compound FAT 40170/B in rats is greater than 2000 mg/kg bw.

Executive summary:

The acute oral toxicity of FAT 40170 was evaluated in a limit test using rats. 5 males and 5 females were administered a single dose of 2000 and 5000 mg/kg bw orally. After administration of the compound, the animals were observed for 14 days. Deaths and clinical symptoms were recorded. At the end of the observation period, animals were killed by exsanguination under ether anaesthesia and an autopsy performed. No mortality was observed with the dose of 2000 mg/kg bw, however 1 male out of 5 and 3 females out of 5 were found dead on Day 1 with the dose of 5000 mg/kg bw. Dyspnoea, exophthalmos, ruffled fur and curved body position were seen, being common symptoms in acute tests. In addition, sedation and diarrhoea was observed. At autopsy no changes caused by the administration of FAT 40170/B were seen.In conclusion, the acute oral LD50 of FAT 40170 in rats of both sexes observed over a period of 14 days is greater than 2000 mg/kg bw.