Tetrasodium 4-amino-5-hydroxy-6-[[2-methoxy-5-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]-3-[[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]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:

March 1982

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPP 81-1 (Acute Oral Toxicity)

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Tetrasodium 4-amino-5-hydroxy-6-[[2-methoxy-5-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]-3-[[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonate

EC Number:

300-644-5

EC Name:

Tetrasodium 4-amino-5-hydroxy-6-[[2-methoxy-5-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]-3-[[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonate

Cas Number:

93951-21-4

Molecular formula:

C27H27N5O20S6.4Na C27H27N5Na4O20S6

IUPAC Name:

tetrasodium 4-amino-5-hydroxy-6-[(2-methoxy-5-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)diazenyl]-3-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)diazenyl]naphthalene-2,7-disulfonate

Test material form:

solid: particulate/powder

Details on test material:

Reactive Blue 250

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

The outbred Sprague-Dawley Rat, weighing 200-300 grams and approximately 8 weeks of age, was used for this study.
The animals were housed and maintained in compliance with the Animal Welfare Act (Pub. L-94-279) 9 CFR Part 3. The rats were not used in any previous study and were acclimated to the laboratory for at least 5 days prior to dosing.
Rats were deprived of food but not water overnight prior to dosing.

The animals were randomized using a computer generated list of random numbers. They were individually identified by ear punch.
Each cage was identified with a cage card displaying the animal numbers, sex, project number, test article, date dosed, dose level and responsible technician's initials .

Husbandry Conditions:
Temperature - 72°F ~ 2°F
Relative Humidity - 45% ~ 5%
Light - 12 hour light/dark cycle
Diet - Wayne Lab-Blox and tap water were provided ad libitum .
Based on our current knowledge no contaminants were known to be in this diet or water that might be expected to interfere with the objectives of the study.

Caging - Stainless steel with elevated wire mesh flooring
3-5 rats/cage by sex

Bedding - Techboard
Shepherd Products Company
Kalamazoo, Michigan 49005

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

The sample was dosed as a 25% w/v suspension in deionized water.

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 females
5 males

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation: clinical signs multiple times on day one, thereafter twice daily; body weight: weekly
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No animals died at 5000 mg/kg

Clinical signs:

other: Within 3 hours the animals were prostrate and ruffled. They appeared recovered within 24 hours. They continued to remain normal throughout the observation period.

Gross pathology:

Gross pathologic examination revealed nothing remarkable.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral lethal dose was tested to be > 5000 mg/kg bw in both male and female rats.

Executive summary:

The sample was dosed as a 25% w/v suspension in deionized water.

One group of ten (5 male & 5 female) albino rats was deprived of food but not water overnight prior to dosing.

The following dosage level was administered:

5.0 g/kg

Animals were observed frequently on the day of dosage, and twice per day thereafter (morning and afternoon). Individual weights

were recorded on the day of dosage, weekly thereafter, and prior to sacrifice.

Gross autopsies were performed on all survivors of the 14 day observation period.

The subject material when studied in male and female albino rats has an acute oral LD₅₀ greater than 5000 mg/kg.