1,8-bis[(4-methylphenyl)amino]anthraquinone

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:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Reference 2

Reference Type:

other company data

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:

A dose of 15000 mg/kg bw of the test substance was applied once to 10 female Wistar rats per gavage. The animals were inspected several times on the day of administration, and twice daily during the following 14-day observation
period (once on Weekends and bank holidays). During inspections, the type, onset, duration, and intensity of clinical signs were recorded and dead animals removed if necessary. The animals were individually weighed at application at the end of the 14-day observation period.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,8-bis[(4-methylphenyl)amino]anthraquinone

EC Number:

201-398-0

EC Name:

1,8-bis[(4-methylphenyl)amino]anthraquinone

Cas Number:

82-16-6

Molecular formula:

C28H22N2O2

IUPAC Name:

1,8-bis[(4-methylphenyl)amino]-9,10-dihydroanthracene-9,10-dione

Specific details on test material used for the study:

Purity: technically pure

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

The acute toxicity experiment was carried out with SPF-bred Wistar rats (strain Wistar TNO W 74). At the start of study the female rats were about 14 weeks old and females 14weeks.
The rats were housed in groups of five animals each under conventional conditions in Makrolon Type-III cages on dust-free wood granules; they were exposed to a room temperature of 22 ± 1.5° C, a 12-hour light/dark cycle (artificial light from 7 a.m. to 7 p.m. CET), and relative humidity of about 60 ± 5 %.
During the study period the animals received feed and tap water ad libitum.
The animals were inspected several times on the day of administration, and twice daily during the following 14-day observation period (once on Weekends and bank holidays). During inspections, the type, onset, duration, and intensity of clinical signs were recorded and dead animals removed if necessary. The animals were individually weighed at application and at the end of the 14-day observation period.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

peanut oil

Details on oral exposure:

The substance was formulated inpeanut oil and once administered to 10 female animals at a constant application volume of 30 ml/kg body weight. A rigid metal gavage was used for that purpose. The animals were inspected several times on the day of administration, and twice daily during the following 14-day observation period (once on Weekends and bank holidays). During inspections, the type, onset, duration, and intensity of clinical signs were recorded and dead animals removed if necessary. The animals were individually weighed at application and at the end of the 14-day observation period.

Doses:

15000 mg/kg bw

No. of animals per sex per dose:

10 female rats/dose

Control animals:

no

Details on study design:

A dose of 15000 mg/kg bw of the test substance was applied once to 10 female Wistar rats per gavage. The animals were inspected several times on the day of administration, and twice daily during the following 14-day observation
period (once on Weekends and bank holidays). During inspections, the type, onset, duration, and intensity of clinical signs were recorded and dead animals removed if necessary. The animals were individually weighed at application at the end of the 14-day observation period.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

discriminating dose

Effect level:

15 000 mg/kg bw

Based on:

test mat.

Mortality:

None of the animals died.

Clinical signs:

other: other: The dose of 15000 mg/kg body eight, which was administered once, was tolerated without symptoms.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 is greater than 15000 mg/kg bw (discriminating dose).

Executive summary:

A dose of 15000 mg/kg bw of the test substance was applied once to 10 female Wistar rats per gavage. The animals were inspected several times on the day of administration, and twice daily during the following 14-day observation period. The dose of 15000 mg/kg body weight, which was administered once, was tolerated without symptoms by all female animals. The LD50 is greater than 15000 mg/kg bw (discriminating dose).