Trisodium bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]naphthalene-1-sulphonato(3-)]chromate(3-)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From July 20 to August 04, 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according 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:

Acid Blue 193

IUPAC Name:

Acid Blue 193

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan-Winkelmann GmbH, Borchen.
- Females nulliparous and non-pregnant: yes.
- Age at study initiation: 8 weeks for male, 9 - 10 weeks for female.
- Weight at study initiation: average 199 g for male and average 173 g for female.
- Housing: conventional Makrolon cages, type III
- Fasting period before study: ca 16 hours before and 4 hours after dosing.
- Diet: standard diet "fixed-formula" Altromin 1324 Pellets, ad libitum.
- Water: libitum.
- Acclimation period: 5 days adaptation.

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 55 ± 5 %
- Photoperiod: 12 hrs dark / 12 hrs light.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

- Volume of administration: 10 mg/kg bw
- Preparation: test substance was formulated in the application medium immediately before the treatment.
- Administration: first animals of a gender (male) were treated with the intended dose. As soon as it could be seen that the dose did not result in a high lethality, the female animals were treated to determine any gender differences.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 animals per sex

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: on the day of application (day 1), animals were examined several times daily; once on weekends and public holidays in the following 14-day observation period, recording the type, beginning, duration and intensity of the clinical symptoms as well as possible dead animals away.
- Frequency of weighing: immediately before application (day 1), after one week and at the end of the 14-day observation period the animals were individually weighed. The individual application volume was calculated by means of the body weight obtained immediately before the application.
- Necropsy of survivors performed: yes.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed.

Clinical signs:

No poisoning phenomena were observed during the 14-day observation time. Eight hours up to a day after the administration of test substance, blue discolouration of faeces was seen.

Body weight:

The growth was not influenced in male and female rats.

Gross pathology:

No abnormalities were observed.

Applicant's summary and conclusion

Interpretation of results:

other: not classified, according to the CLP Regulation (EC) No 1272/2008

Conclusions:

LD50 (male and female) > 2000 mg/kg bw

Executive summary:

Oral acute toxicity potential of test material was tested in rats, following procedures outlined in OECD guideline 401. A single dose of 2000 mg/kg bw was administered by gavage. Animales were observed for 14 days after dosing.

No death occurred during the main test and no poisoning phenomena were observed during the 14-day observation time. Eight hours up to a day after administration of test substance, blue discolouration of faeces was reported. No abnormalities were revealed by necropsy.

Conclusion

LD50 (male and female) > 2000 mg/kg bw