1,4-bis[[4-(1,1-dimethylethyl)phenyl]amino]-5,8-dihydroxyanthraquinone

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:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

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:

The test substance was dissolved in peanut oil at room temperature. It was then administered intragastrically to 10 female animals each of the doses 10000 and 15000 mg/kg respectively by means of a rigid metal 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 were removed. The time of death of the deceased animals was documented.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,4-bis[[4-(1,1-dimethylethyl)phenyl]amino]-5,8-dihydroxyanthraquinone

EC Number:

225-443-9

EC Name:

1,4-bis[[4-(1,1-dimethylethyl)phenyl]amino]-5,8-dihydroxyanthraquinone

Cas Number:

4851-50-7

Molecular formula:

C34H34N2O4

IUPAC Name:

1,4-bis[(4-tert-butylphenyl)amino]-5,8-dihydroxy-9,10-dihydroanthracene-9,10-dione

Specific details on test material used for the study:

Designation: Macrolex Green G
Physical state: solid
Appearance: green powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Experimental Animais
The acute toxicity experiment was carried out with young-adult SPF-bred female Wistar rats (Strain TNO/W70 (SPF Cpb).
The rat is the preferred species for investigating acute oral toxicity in mammals. At the start of the experiment, the rats were about 8 weeks of age.
The average initial weight of the female animals was 130 g. 10 rats were used per dose.

Housing Conditions
The rats were housed in groups of 5 under conventional conditions in Makrolon® Type-III cages on low-dust wood granules at a room temperature of 22 ± 2 °C, with humidity of about 50 ± 10%.

Nutrition
The animals received standard diet and tap water a libitum.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

peanut oil

Details on oral exposure:

The test substance was dissolved in peanut oil at room temperature. It was then administered intragastrically to 10 female animals each of the doses 10000 and 15000 mg/kg respectively by means of a rigid metal gavage on a constant application volume of 30 ml/kg body weight.

Doses:

10000 or 15000 mg/kg bw.

No. of animals per sex per dose:

10 female animals/dose.

Control animals:

no

Details on study design:

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 an dead animals were removed. The time of death of the deceased animals was documented. The animals were weighed individually directly before administration and groupwise after one week and at the end of the observation.

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:

No animals died during the 14-day observation period.

Clinical signs:

other: other: After single administration of 10000 and 15000 mg/kg MACROLEX Green G all rats had a rough coat. There were no other signs of intoxication.

Gross pathology:

Not examined.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

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

Executive summary:

A single dose of 10000 or 15000 mg/kg bw of the test substance was applied to 10 female Wistar rats each per gavage. The animals were inspected several times on the day of administration, and twice daily during the following 14-day observation period. After the single administration of 10000 and 15000 mg/kg MACROLEX Green G all rats had a rough coat. There were no other signs of intoxication. No animals died during the 14-day observation period. The LD50 was greater than 15000 mg/kg bw (discriminating dose).