Disodium 1,1'-isopropylidenedi-p-phenylene bis[2-[[5-amino-3-methyl-1-(3-sulphonatophenyl)-1H-pyrazol-5-yl]azo]benzenesulphonate]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

06 June 1975

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

Report date:

1975

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 1,1'-isopropylidenedi-p-phenylene bis[2-[[5-amino-3-methyl-1-(3-sulphonatophenyl)-1H-pyrazol-5-yl]azo]benzenesulphonate]

EC Number:

276-882-8

EC Name:

Disodium 1,1'-isopropylidenedi-p-phenylene bis[2-[[5-amino-3-methyl-1-(3-sulphonatophenyl)-1H-pyrazol-5-yl]azo]benzenesulphonate]

Cas Number:

72828-69-4

Molecular formula:

C47H42N10O12S4.2Na

IUPAC Name:

disodium 1,1'-isopropylidenedi-p-phenylene bis[2-[[5-amino-3-methyl-1-(3-sulphonatophenyl)-1H-pyrazol-5-yl]azo]benzenesulphonate]

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

An orange powder, labelled FAT 21015/A.

Specific details on test material used for the study:

Test Compound:
An orange powder, labelled FAT 21015/A.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Animals:
Healthy Sprague-Dawley derived rats, bred on the premises, aged 5 weeks, having an average body weight of 148 g males and 115 g females.

Husbandry:
Rats were caged singly and kept in a room maintained at a temperature of 21°C. (+/-2°). Animals were subjected to 12 hours artificial light and 12 hours darkness in each 24 hour period. A commercial pelleted diet (Oakes Special Diet with added Vit. E) was fed ad lib. Water was available at all times.

Ten rats (5M + 5F) Were used for this study.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Administration of Compound:
A 25 % w/ v solution of the compound in deionised water was administered as a single dose by gavage to rats which had been fasted for 18 hours, at a dose rate of 20ml/kg (equivalent to 5g/kg compound).

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

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 was performed.

Statistics:

None

Results and discussion

Preliminary study:

None

Effect levels

Key result

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:

other: 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.

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral median lethal dose (LD50) of FAT 21015/A in rats is greater than 5000 mg/kg bw.

Executive summary:

The acute oral toxicity of FAT 21015/A in rats was investigated in a study conducted according to a methodology equivalent to OECD Guideline 401. A single dose of 5000 mg/kg bw was administered to a group of 5 males and 5 females orally. 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. Hence, the acute oral median lethal dose (LD50) of FAT 21015/A in rats was found to be greater than 5000 mg/kg bw.