Disodium [N-[7-hydroxy-8-[(2-hydroxy-5-mesylphenyl)azo]-1-naphthyl]acetamidato(2-)][2-hydroxy-3-[(2-hydroxy-1-naphthyl)azo]-5-nitrobenzenesulphonato(3-)]chromate(2-)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Justification for type of information:

Justification for read across is detailed in the report attached to the IUCLID section 13.

Cross-reference

Reason / purpose for cross-reference:

read-across source

Reference

Endpoint:

acute toxicity: oral

Type of information:

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

Adequacy of study:

key study

Study period:

1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Justification for type of information:

Justification for read across is detailed in the report attached to the IUCLID section 13.

Reason / purpose for cross-reference:

read-across source

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

None

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Specific details on test material used for the study:

None

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

Weight: 99 to 118g

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

None

Doses:

FAT 20013/A was prepared as a 30 % suspension in water and administered at a maximum dosage volume of 16.7ml/kg bodyweight. Rats treated with water alone (16.7ml/kg) served as controls.

No. of animals per sex per dose:

5 animals per sex

Control animals:

yes

Details on study design:

None

Statistics:

None

Preliminary study:

None

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 95% CL not specified

Mortality:

No mortality observed.

Clinical signs:

Signs of reaction to treatment, observed within a few hours of dosing included piloerection, lethargy, moderate diarrhoea and diuresis. The urine of all. animals was observed to be blue-black in colour. A slight increase in respiratory rate was observed six hours after treatment.

Body weight:

None

Gross pathology:

None

Other findings:

None

None

Interpretation of results:

other: not classified

Remarks:

Classification criteria according to the CLP Regulation 1272/2008 and its amendments

Conclusions:

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

Executive summary:

The acute oral toxicity of the Similar substance 01 was evaluated in a limit test using rats. 5 males and 5 females were administered a single dose of 5000 mg/kg bw orally. 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, animals were killed by exsanguination under ether anaesthesia and an autopsy performed. No deaths occurred. Signs of reaction to treatment, observed within a few hours of dosing included piloerection, lethargy, moderate diarrhoea and diuresis. The urine of all animals was observed to be blue-black in colour. At autopsy no changes caused by the administration of FAT 20013/A were seen. In conclusion, the acute oral LD50 in rats of both sexes observed over a period of 14 days is greater than 5000 mg/kg bw.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

None

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Similar substance 01 of Acid Black 213

IUPAC Name:

Similar substance 01 of Acid Black 213

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

None

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

Weight: 99 to 118g

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

None

Doses:

FAT 20013/A was prepared as a 30 % suspension in water and administered at a maximum dosage volume of 16.7ml/kg bodyweight. Rats treated with water alone (16.7ml/kg) served as controls.

No. of animals per sex per dose:

5 animals per sex

Control animals:

yes

Details on study design:

None

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.

Remarks on result:

other: 95% CL not specified

Mortality:

No mortality observed.

Clinical signs:

Signs of reaction to treatment, observed within a few hours of dosing included piloerection, lethargy, moderate diarrhoea and diuresis. The urine of all. animals was observed to be blue-black in colour. A slight increase in respiratory rate was observed six hours after treatment.

Body weight:

None

Gross pathology:

None

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

other: not classified

Remarks:

Classification criteria according to the CLP Regulation 1272/2008 and its amendments

Conclusions:

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

Executive summary:

The acute oral toxicity of the Similar substance 01 was evaluated in a limit test using rats. 5 males and 5 females were administered a single dose of 5000 mg/kg bw orally. 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, animals were killed by exsanguination under ether anaesthesia and an autopsy performed. No deaths occurred. Signs of reaction to treatment, observed within a few hours of dosing included piloerection, lethargy, moderate diarrhoea and diuresis. The urine of all animals was observed to be blue-black in colour. At autopsy no changes caused by the administration of FAT 20013/A were seen. In conclusion, the acute oral LD50 in rats of both sexes observed over a period of 14 days is greater than 5000 mg/kg bw.