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

25.05. to 08.06. 1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

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:

Internal Guideline Hoechst AG

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reactive Blue 203

IUPAC Name:

Reactive Blue 203

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Test item: Reactive Blue 203

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: -
- Weight at study initiation: 191 to 202 g
- Fasting period before study: 16 hours before to 2 hours after dosing
- Housing: group-caging (10/cage)
- Diet: Altromin 1324 ad libitum
- Water: tap ad libitum
- Acclimation period: -


IN-LIFE DATES: From: 25. May To: 08. June 1982

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25%
- Amount of vehicle (if gavage): 20 mL/kg

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: body weight: weekly; clinical signs: at least daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

-

Results and discussion

Preliminary study:

NA

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

no deaths

Clinical signs:

other: no effects

Gross pathology:

no effects

Other findings:

Within 15 minutes after dosing all animals showed bluish discoloration of skin, apathia, bluish discoloration of feces and diarrhea. 25 minutes after application the animals showed hunched and prone position and piloerection as well as bluish urine. All effects were fully reversible within 24 hours.
Behaviour and gain of body weight were not effected during the recovery period.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

LD50 above 5000 mg/kg bw.
No classification necessary

Executive summary:

A study was conducted to assess the acute oral toxicity of the test substance in rats after a single dose with a 14-day post observation period. Ten fasted female Wistar rats received a single oral (gavage) dose of 5000 mg/kg bw. A 25% suspension of test substance was prepared in softened water and administered at a volume of 20 mL/kg bw.

No mortality occurred. Fifteen minutes after test substance administration,all treated rats showed apathia, blue skin blue faeces and diarrhea. After 25 minutes, hunched posture, prone position, piloerection and bluish discoloured urine was observed.

No clinical signs of toxicity were observed from 24 hours onward and no significant macroscopic abnormalities were seen at necropsy.

 

Under the study conditions, the oral LD50 was found to be >5000 mg/kg bw in rats.