Trisodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulphonatonaphthyl]azo]-2,5-dimethylphenyl]azo]benzene-1,4-disulphonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

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

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

Principles of method if other than guideline:

The test substance was administered orally by gavage at single dose to a group of experimental animals. Subsequently observations of effects and deaths were made. At the end of the observation period the surviving animals were sacrificed and autopsied.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulphonatonaphthyl]azo]-2,5-dimethylphenyl]azo]benzene-1,4-disulphonate

EC Number:

274-410-5

EC Name:

Trisodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulphonatonaphthyl]azo]-2,5-dimethylphenyl]azo]benzene-1,4-disulphonate

Cas Number:

70210-13-8

Molecular formula:

C27H22ClN9O9S3.3Na

IUPAC Name:

trisodium 2-{[4-({4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulfonato-1-naphthyl}diazenyl)-2,5-dimethylphenyl]diazenyl}benzene-1,4-disulfonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Specific details on test material used for the study:

Name: FAT 40075/A
Purity: 74.5 %

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 6-7 weeks
- Weight at study initiation: 234 g (males), 160 g (females)
- Fasting period before study: 18 h
- Housing: Rats were caged singly
- Diet: Commercial pelleted diet (ad libitum)
- Water: Ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 2 °C.
- Photoperiod (hrs dark / hrs light): 12 h/12 h

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: deionised water

Details on oral exposure:

The test substance was administered as a single dose by gavage as a 25 % w/v solution in deionised water at a rate of 20 mL/kg (equivalent to 5 g/kg bw of test substance) to rats which had been fasted for 18 h.

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5/sex/dose

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 d.
- At the end of the observation period, surviving animals were killed by exsanguinations under other anaesthesia and an autopsy performed.
- Other examinations performed: Mortality, clinical symptoms.

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 3 725 mg/kg bw

Based on:

act. ingr.

Mortality:

No death occurred during the study

Clinical signs:

other: No clinical signs were observed during the study period.

Gross pathology:

No changes in organs or tissues were observed at autopsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 of the test substance was found to be >5000 mg/kg bw (i.e. ca. >3725 mg a.i./kg bw) in rats.

Executive summary:

A study was conducted to assess the acute oral toxicity of the test substance (of ca. 74.5 % purity) in Sprague-Dawley rats. This test was conducted in accordance to guideline similar to OECD 401. Group of 10 fasted animals (5/sex/dose) received a single oral (gavage) dose of 5000 mg/kg bw. Parameters assessed included mortality, clinical symptoms and autopsy findings after a 14 d observation period. No mortality and no clinical symptoms were observed throughout the observation period and no significant changes in organs or tissues were seen at autopsy. Under the study conditions, the oral LD50 of the test substance was found to be >5000 mg/kg bw (i.e. ca. >3725 mg a.i./kg bw) in rats.