Hydrogen bis[3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-4-hydroxybenzene-1-sulphonamidato(2-)]chromate(1-)

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:

September 10, 1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to 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:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Acid Orange 060 - Similar Substance 01

IUPAC Name:

Acid Orange 060 - Similar Substance 01

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation:6 weeks
- Weight at study initiation:average body weight of 170 g (male) and 145 g (female)
- Fasting period before study:
- Housing:Rats were caged singly and kept in a room
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Photoperiod (hrs dark / hrs light):12 hours artificial light and 12 hours darkness in each 24 hour period

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

tap water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25 % w/v

MAXIMUM DOSE VOLUME APPLIED:20 ml/kg (equivalent to 5 g/kg of compound)

Doses:

20 ml/kg (equivalent to 5000 mg/kg bw)

No. of animals per sex per dose:

Ten rats (5 males and 5 females)

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: No data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, mortality

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred during the 14 day observation period.

Clinical signs:

No clinical symptoms were recorded during the 14 day observation period.

Gross pathology:

At autopsy no changes in organs or tissues caused by the administration of the test compound were seen.

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Conclusions:

LD50 > 5000 mg/kg bw

Executive summary:

Method

The compound was tested on 10 healthy Sprague-Dawley rats (5 males/ 5 females), aged 6 weeks having average body weight of 170g (male) and 145 g (female). Rats were caged singly and kept in a room maintained at a temperature of 21 °C with 12 hour light/dark period.

A 25 % w/v suspension of the compound in tap-water was administered as a single dose by gavage to rats which had been fasted for 18 hours, at a dose rate of 20 ml/kg (equivalent to 5000 mg/kg bw).

Observation

After administration of the compound, the animals were observed for 14 days. Deaths and clinical symptoms were recorded. At the end of the observation period, surviving animals were killed by exsanguination under ether anaesthesia and an autopsy performed. No clinical symptoms were recorded and no deaths occurred during the 14 day observation period. At autopsy no changes in organs or tissues caused by the administration of the test compound were seen.

Conclusion

The acute oral LD50 in rats of both sexes observed over a period of 14 days is greater than 5000 mg/kg bw. The compound has therefore is not considered to cause acute toxicity to the rat by this route of administration.