1,4-bis(mesitylamino)anthraquinone

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: well performed GLP compliant OECD guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Principles of method if other than guideline:

The limit dose applied was 5000 mg/kg bw.

Allthough the wording of study title "RANGE-FINDING" purports a reduced study design a full limit test was performed according to OECD guidline 401.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,4-bis(mesitylamino)anthraquinone

EC Number:

204-155-7

EC Name:

1,4-bis(mesitylamino)anthraquinone

Cas Number:

116-75-6

Molecular formula:

C32H30N2O2

IUPAC Name:

1,4-bis(mesitylamino)anthraquinone

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Bantin & Kingman Ltd., Grimston, Aldborough, Hull, U.K.
- Age at study initiation: approximately five to eight weeks
- Weight at study initiation: males : 126 - 138 g, females: 120 - 125 g,
- Fasting period before study: one night before dosing, 2 hours after dosing
- Housing: in groups of up to five by sex in solid-floor polypropylene cages with sawdust bedding
- Diet: Rat and Mouse Expanded Diet No.1, Special Diet Services Limited, Witham, Essex, U.K (ad libitum):
- Water: drinking water (ad libitum):
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 45 - 64
- Air changes (per hr): approx. 15
- Photoperiod : 12 hrs dark / 12 hrs light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

Concentration: 500 mg/ml
Dose volume: 10 ml/kg bw

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

five males and five females

Control animals:

no

Details on study design:

All animals were dosed once only by gavage using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing.

Deaths and overt signs of toxicity were recorded 1/2, I, 2 and 4 hours after dosing and subsequently once daily for 14 days.
Individual bodyweights were recorded on the day of treatment (day 0) and on days 7 and 14.

Results and discussion

Preliminary study:

DOSE LEVEL CONCENTRATION DOSE VOLUME NUMBER OF RATS
mg/kg mg/ml ml/kg MALE FEMALE
5000 500 10 1 1
2000 200 10 1 1
200 20 10 1 1

No deaths occured during the observation time of 5 days

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths

Clinical signs:

other: No signs of systemic toxicity

Gross pathology:

No abnormalities were noted at necropsy of animals killed at the end of the study

Other findings:

No other findings reported

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral median lethal dose (LD5O) of the test material in the Sprague-Dawley strain rat was found to be greater than 5000 mg/kg bodyweight.

Executive summary:

A study was performed to assess the acute oral toxicity of the test material in the Sprague-Dawley strain rat. The method used followed that described in the OECD Guidelines for Testing of Chemicals (1981) No. 401 "Acute Oral Toxicity" referenced as Method B1 in Commission Directive 84/449/EEC.

Following a range-finding study (1 male, 1 female with the doses 5000, 2000 and 200 mg/kg bw), a group of ten fasted animals (five males and five females) was given a single oral dose of test material preparation, administered as a solution in arachis oil B.P. at a dose level of 5000 mg/kg bodyweight.

There were no deaths after a observation period of 14 days. All animals showed expected gain in bodyweight during the study. Neither signs of systemic toxicity nor abnormalities were noted.

Therefore, the acute oral median lethal dose (LD5O) of the test material in the Sprague-Dawley strain rat was found to be greater than 5000 mg/kg bodyweight.