Trisodium 5-[[4-chloro-6-(methylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Justification for type of information:

None

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Principles of method if other than guideline:

None

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium 5-[[4-chloro-6-(ethylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate

EC Number:

276-911-4

EC Name:

Trisodium 5-[[4-chloro-6-(ethylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate

Cas Number:

72829-25-5

Molecular formula:

C27H22ClN7O10S3.3Na

IUPAC Name:

trisodium 5-({4-chloro-6-[ethyl(phenyl)amino]-1,3,5-triazin-2-yl}amino)-4-hydroxy-3-[(2-sulfonatophenyl)diazenyl]naphthalene-2,7-disulfonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Specific details on test material used for the study:

None

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Animals:
Healthy Sprague-Dawley derived rats, bred on the premises, aged 5 weeks, having an average body weight of 118 g (M) and 118 g (F).

Husbandry:
Rats were caged singly and kept in a room maintained at a temperature of 21°C. (+/-2). Animals were subjected to 12 hours artificial light and 12 hours darkness in each 24 hour period. A commercial pelleted diet (Oakes Special Diet with added Vit. E) was fed ad lib. Water was available at all times.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

The compound (as a 50% w/v suspension in water) was administered as a single dose by gavage to rats which had been fasted for 18 hours, at a rate of 10 ml/kg equivalent to 5 g/kg of compound.

Doses:

None

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

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, surviving animals were killed by exsanguination under ether anaesthesia and an autopsy performed.

Statistics:

None

Results and discussion

Preliminary study:

None

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 95% Cl not specified

Mortality:

None

Clinical signs:

No clinical symptoms were recorded and no deaths occurred.

Body weight:

None

Gross pathology:

At autopsy no changes caused by the administration of FAT 40034/A were seen.

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 40034/A in rats is greater than 5000 mg/kg bw.

Executive summary:

The acute oral toxicity of FAT 40034 was evaluated in a limit test using Sprague-Dawley rats according to a methodology similar to OECD Guideline 401. 5 males and 5 females were administered a single dose of 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, surviving animals were killed by exsanguination under ether anaesthesia and an autopsy performed. No clinical symptoms were recorded and no deaths occurred. At autopsy no changes caused by the administration of FAT 40034/A were seen. In conclusion, the acute oral LD50 of FAT 40034 in rats of both sexes observed over a period of 14 days is greater than 5000 mg/kg bw.