2-ethylanthraquinone

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 1990-09-18 to 1990-12-19

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline-conform study performed under GLP

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)

Version / remarks:

adopted on 24 February 1987

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylanthraquinone

EC Number:

201-535-4

EC Name:

2-ethylanthraquinone

Cas Number:

84-51-5

Molecular formula:

C16H12O2

IUPAC Name:

2-ethyl-9,10-anthraquinone

Details on test material:

- Name of test material (as cited in study report): 2-Ethylanthraquinone
- Physical state: pale yellow flakes
- Analytical purity: >=95%
- Impurities (identity and concentrations): not reported
- Composition of test material, percentage of components: not reported
- Isomers composition: not reported
- Purity test date: not reported
- Lot/batch No.: 146-332
- Expiration date of the lot/batch: not reported
- Stability under test conditions: not reported
- Storage condition of test material: not reported

Test animals

Species:

rat

Strain:

other: SPF-derived Hsd/Cpb:WU Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan/CPB, Zeist, The Netherlands
- Age at study initiation: not reported
- Weight at study initiation: male: 175-200 g, female: 150-175 g
- Fasting period before study: yes (19 hours prior to dosing until 5 hours after dosing)
- Housing: housed continuously in macrolon cages using dust free sawdust as bedding material with two or three animals per cage
- Diet (e.g. ad libitum): ad libitum (standard laboratory diet RHM-TM, Hope Farms, Woerden, The Netherlands) except for a period of about 19 hours prior to dosing until 5 hours after dosing.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-23
- Humidity (%): 45-70
- Air changes (per hr): 16
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1990-09-18 To: 1990-10-02

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 0.29 g/mL
- Amount of vehicle (if gavage): 4.97 mL/kg
- Justification for choice of vehicle: not reported
- Lot/batch no. (if required): not reported
- Purity: not reported

MAXIMUM DOSE VOLUME APPLIED: 7 mL/kg

DOSAGE PREPARATION (if unusual): Test material was suspended in corn oil by grinding the test material with the vehicle at room temperature.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males, 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rats were weighed one day before dosing, just prior to dosing and at 2, 7 and 14 days after dosing. They were observed from 0-0.5 hour and at 1.5, 3, 5, 24 and 48 hours after dosing and thereafter on each day till the end of the experiment.
- Necropsy of survivors performed: yes
- Other examinations performed: mortality, clinical signs, body weight, gross-autopsy

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

One female rat died seven days after treatment.

Clinical signs:

other: The following signs were observed: diminished respiratory rate and respiratory difficulties, diminished locomotor activity, abnormal gait and body posture, pilo-erection, positional passivity, irritability (females), diminished body tone, ptosis (1 male,

Gross pathology:

Gross post-mortem examination of the rat that died during the observation period showed slight staining round nose, dry faeces, absent thymus, dark and enlarged adrenals and blood stained caecal contents. Examination of the animals surviving to the end of the observation period, revealed no effects.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral LD50 was established to be greater than 2000 mg/kg in male and female rats. The substance does not to be classified for acute oral toxicity according to Regulation (EC) No 1272/2008 (CLP).

Executive summary:

The aim of this GLP-study was to assess the acute oral toxicity of 2-ethylanthraquinone in male and female rats. The procedure used was in accordance with OECD guideline 401. For this purpose, a single oral dose of 2-ethylanthraquinone suspended in corn oil was given by stomach tube to groups of five male and five female fasted rats. The dose level was 2000 mg/kg in males and females. The animals were weighed one day before dosing, just prior to dosing and at 2, 7 and 14 days after dosing. Any sign of intoxication occurring during the 14-day observation period was recorded. Gross post-mortem examination was done on all rats that died during the study and on the survivors at the end of the 14-day observation period. One female rat died 7 days after dosing. None of the male rats died within the 14-day observation period.

After oral administration of 2-ethylanthraquinone, males and females showed small weight losses or reduced gains during the first few days after dosing. Thereafter the rats grew with normal weight-gains, except for the female rat that died. The clinical signs observed were mainly indicative of effects on motor coordination (decreased locomotor activity, abnormal gait and body posture), on autonomous nervous system (decreased respiratory rate, respiratory difficulties, pilo-erection, diarrhea), on central nervous system (positional passivity), on mood (vocalization, irritability) and on muscle tone (paralysis, diminished body tone). Time of onset of the first signs was within 1.5 hour after dosing. All signs had disappeared in males 5 days after treatment and in females 6 days after treatment, except for the female rat that died during the observation period. Autopsy of the rat that died 7 days after treatment showed slight staining round nose, dry faeces, absent thymus, dark and enlarged adrenals and blood stained caecal contents. At autopsy 14 days after dosing, no abnormalities were observed in the surviving rats.

The acute oral LD50 was established to be greater than 2000 mg/kg in male and female rats. The substance does not to be classified for acute oral toxicity according to Regulation (EC) No 1272/2008 (CLP).