Trisodium bis[3-[[1-(anilinocarbonyl)-2-oxopropyl]azo]-5-chloro-2-hydroxybenzenesulphonato(3-)]cobaltate(3-)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

other: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

from October 25 to November 30, 1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

The test was conducted by means of Read Across approach. The reliability of the source study report is 2. Further information was attached at section 13

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

no

Remarks:

Pre GLP.

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

Acid Yellow 204 - Similar Substance 01

IUPAC Name:

Acid Yellow 204 - Similar Substance 01

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

other: RAIf (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Tif
- Age at study initiation: 7 to 8 weeks old
- Weight at study initiation: males 206.5 g, females 182 g
- Fasting period before study: Animals fasted overnight
- Housing: 5 in Macrolon cages (type 3)
- Diet: ad libitum rat food NAFAG, Gossau SG
- Water: ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 °C
- Humidity (%): 55 ± 10 %
- Photoperiod: 10 hours of light during the day

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: carboxymethyl-cellulose 2 % (w/v) in dest. water

Details on oral exposure:

VEHICLE
- Concentration in vehicle:20 ml/kg bw

Doses:

5000, 7000, 8000, 10000 mg/kg

No. of animals per sex per dose:

5 x sex x doses

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:Bodyweights were recorded immediately prior to dosing (control weights) and at 7 and 14 days
- Necropsy of survivors performed: yes

Statistics:

LD50 including 95 % confidence limits are calculated by the logit model.

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD0

Effect level:

ca. 10 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality observed

Clinical signs:

other: Dhiarroea, Ruffled fur, Dyspnoea.

Gross pathology:

No substance related gross organ changes were seen

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Conclusions:

The acute oral LD50 of test substance in rats of both sexes observed over a period of 14 days is greater than 10000 mg/kg bw.

Executive summary:

The acute oral LD50 of test substance in rats of both sexes observed over a period of 14 days is greater than 10000 mg/kg bw. The test material has therefore practically no acute toxicity to the rat by this route of administration.