Tetrasodium 3,3'-[[6-[(2-hydroxyethyl)amino]-1,3,5-triazine-2,4-diyl]bis[imino(2-methyl-4,1-phenylene)azo]]bisnaphthalene-1,5-disulphonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

5 male and 5 female rats were dosed with 2000 mg/kg Bayscript Yellow CA 51069 by gavage. Mortality, clinical signs and body weight were recorded for 14 days.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Tetrasodium 3,3'-[[6-[(2-hydroxyethyl)amino]-1,3,5-triazine-2,4-diyl]bis[imino(2-methyl-4,1-phenylene)azo]]bisnaphthalene-1,5-disulphonate

EC Number:

256-851-5

EC Name:

Tetrasodium 3,3'-[[6-[(2-hydroxyethyl)amino]-1,3,5-triazine-2,4-diyl]bis[imino(2-methyl-4,1-phenylene)azo]]bisnaphthalene-1,5-disulphonate

Cas Number:

50925-42-3

Molecular formula:

C39H30N10Na4O13S4

IUPAC Name:

tetrasodium 3,3'-({6-[(2-hydroxyethyl)amino]-1,3,5-triazine-2,4-diyl}bis[imino(2-methyl-4,1-phenylene)diazene-2,1-diyl])dinaphthalene-1,5-disulfonate

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

At the start of the experiment, male rats were about 8 weeks of age and females about 9 weeks. The average initial weight of males was 184 g and of females 164 g. The mean deviation in animal weights was less than 20%. Females were nulliparous and non-pregnant.
Prior to study initiation the condition of the animals' health was checked. Only healthy animals without any clinical signs were included in the study. Animals were acclimated for at least 4 days before application. Five rats were used per dose and sex.

The rats were housed individually under conventional conditions in Makrolon® Type-III cages on low-dust wood granules, at a room temperature of 22 ± 2° C, with a 12-hour light/dark cycle (artificial lighting), relative humidity of about 50 ± 10% and approximately ten air changes per hour in groups of 5 animals.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

The test substance was suspended under stirring on a magnetic stirrer in tap water at room temperature and intragastrically applied at a constant application volume of 10 ml/kg body weight. A rigid metal gavage was used for that purpose.

The test substance was formulated in the vehicle immediately before the start of the study. Because of the short time between preparation and application of the test substance analytical investigations on stability and homogeneity have not been performed.

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 male and 5 female rats/dose

Control animals:

no

Details on study design:

The animals were inspected several times on the day of administration, and twice daily during the following 14-day observation period (once on weekends and bank holidays). During inspections, the type, onset, duration, and intensity of clinical signs were recorded and dead animals were removed if necessary. The date of death was recorded.

The animals were individually weighed directly before administration, after one week and at the end of the 14-day observation period. The application volume for each individual animal was based on its body weight just before application.

Gross pathological examinations were done on all animals sacrificed under deep diethyl ether anesthesia at the end of study. Necropsy records were prepared for all animals.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

discriminating dose

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Mortality:

None of the rats died.

Clinical signs:

other: No symptoms attributable to BAYSCRIPT Yellow CA 51069 occurred.

Gross pathology:

The animals sacrificed at the end of the study showed no gross pathological abnormalities.

Any other information on results incl. tables

No findings or symptoms appeared that could be attributed to the administration of BAYSCRIPT Yellow CA 51069. The LD50 values for male and female rats were greater than 2000 mg/kg body weight.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

A single oral dose of 2000 mg/kg bw caused no deaths. The LD50 is greater than 2000 mg/kg bw (discriminating dose).

Executive summary:

Acute toxicological investigations were conducted after oral administration of BAYSCRIPT Yellow CA 51069 to male and female Wistar rats.

The LD50 values for male and female rats were greater than 2000 mg/kg body weight.

No findings or symptoms appeared that could be attributed to the administration of BAYSCRIPT Yellow CA 51069.