2-(4-methyl-3-pentenyl)anthraquinone

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study according to guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test animals

Species:

rat

Strain:

other: HsdCpb: WU

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: males 8 weeks; females 9 weeks
- Weight at study initiation: males 159-180 g; females 128-155 g
- Fasting period before study: approx. 16 hours before treatment
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0-22.0°C
- Humidity (%): 50-58%
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 05.12.1995 To: 21.12.1995

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

peanut oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: males 100 mg/ml, females 21.5 and 100 mg/ml
- Amount of vehicle: 21.5 ml/kg bw
- Lot/batch no. (if required): 1545501

MAXIMUM DOSE VOLUME APPLIED: 21.5 ml/kg bw

Doses:

males 2150 mg/kg bw; females 464 and 2150 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: continuously for the first 4 to 6 hours after dosing and once daily thereafter
- Frequency of weighing: day 0 (prior to dosing), day 7 and day 14
- Necropsy of survivors performed: yes
- Other examinations performed: gross examination of organs at necropsy

Results and discussion

Preliminary study:

not performed

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 150 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

1 840 mg/kg bw

Based on:

test mat.

Remarks on result:

other: graphical estimation

Mortality:

Deaths occurred one to two days after administration:
0/5 males and 3/5 females at 2150 mg/kg,
0/5 females at 464 mg/kg.

Clinical signs:

In male rats a dose of 2150 mg/kg produced only slight hypokinesia, piloerection, and diarrhea on the 2nd day of the study.
In females this dose (2150 mg/kg) caused identical symptoms though more severe. One rat had chromodacryorrhea. Additionally three of these
animals died within 48 hours after treatment. A dose of 464 mg/kg did not produce any effects.

Gross pathology:

At necropsy two of the three deceased animals showed dark stains on the small intestines and one deceased rat had a brown material within the small intestine.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Remarks:

Migrated information

Conclusions:

The LD 50 value for male rats is above 2150 mg/kg (limit test) and for female animals approx. 1840 mg/kg (graphical estimation).