Disodium [6-[(2-anilino-1-naphthyl)azo]-2,4-dinitrophenolato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]naphthalene-1-sulphonato(3-)]chromate(2-)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Acid Black 222

IUPAC Name:

Acid Black 222

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: KFM, CH-4414 Füllinsdorf, Switzerland.
- Age at study initiation: young adult male and female.
- Weight at study initiation: ranged between 150 and 190 g.
- Fasting period before study: access of food only was prevented approximately 18 hours prior and four hours after the dosing.
- Housing: the rats were housed individually in Macrolon cages.
- Diet: standard laboratory pelleted diet (KLIBA no. 24-343-4 from Klingentalmühle AG., Basle), ad libitum. The batch of diet used was analysed for chemical and microbiological contaminants.
- Water: ad libitum. The water bottles were withdrawn two hours prior and four hours after dosing.
- Acclimation period: about five days.

ENVIRONMENTAL CONDITIONS
- Temperature: 23 ± 2 °C
- Humidity: 30 - 70 %
- Air changes: approximately 15 changes/hour.
- Photoperiod: 12 hrs dark / 12 hrs light.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

- Dosed volume was 20 ml/kg bw
- Dilution: test item was diluted in 25 % water.

Doses:

5000 mg/kg

No. of animals per sex per dose:

five male and five female

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations:animals were observed soon after dosing, then at hourly intervals for the remainder day 1. On the subsequent days the animals were observed once in the morning and once in the Iate afternoon. Clinical signs were recorded at each observation. The following was recorded: approximate time of death; the nature, severity, approximate time of onset and duration of each toxic sign; individual body weights on day 1, 7 and 14.
- Necropsy of survivors performed: yes; surviving animals were killed after two weeks. All animals which died during the study and those killed after two weeks were subjected to a macroscopic postmortem examination. Macroscopic appearance of abnormal organs was recorded.

PRELIMINARY TEST
A preliminary study was carried out to establish a dosing regimen, using groups of two males and two females at one dosage, using 20 ml/kg bw.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No deaths occurred.

Clinical signs:

The animals were flaccid, weak and showed rough coat, decreased movement and diarrhea.

Gross pathology:

No special findings.

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

LD50 > 5000 mg/kg bw (males and females)

Executive summary:

Ten rats were treated at a dosage level of 5000 mg/kg bw. The substance was administered as a single dose by gavage. After administration of the compound, animals were observed for 14 days; at the end of the observation period, surviving animals were killed and an autopsy performed.

No deaths occurred during the 14 day observation period; animals appeared flaccid, weak and showed rough coat, decreased movement and diarrhea. At autopsy no special findings were seen.

Conclusion

LD50 > 5000 mg/kg bw (males and females)