1-cyclohexyl-1H-pyrrole-2,5-dione

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

22 February and 16 April 1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

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:

Healthy male and female 5-week-old Crj:CD (SD) rats (weight: 120 to 150 g in males and 110 to 145 g in females) were used (10 animals in a group, total 50 each of males and females). A 0.5 (w/v) % suspension of the sample in water containing 7.5 (w/v)% of gum arabic was given to the animals by oral gavage using gastric tube. Animals were observed for general symptoms for 14 days. The LD50 was calculated from the number of survivals and deaths using Bliss's probit model. A preliminary study had been conducted for the sample administration and determined the maximum dose of 44.4 mL/kg. The lower 4 dose levels of 35.5 mL/kg, 28.4 mL/kg, 22.7 mL/kg, and 18.2 mL/kg were selected from the maximum dose at a common ratio of 1.25.

GLP compliance:

not specified

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1-cyclohexyl-1H-pyrrole-2,5-dione

EC Number:

216-630-6

EC Name:

1-cyclohexyl-1H-pyrrole-2,5-dione

Cas Number:

1631-25-0

Molecular formula:

C10H13NO2

IUPAC Name:

1-cyclohexyl-2,5-dihydro-1H-pyrrole-2,5-dione

Test material form:

solid: flakes

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: A suspension of the sample in water containing gum arabic.

Details on oral exposure:

VEHICLE
- Concentration in vehicle: A 0.5% w/v suspension of the sample in water containing 7.5% w/v of gum arabic
- Amount of vehicle (if gavage):
- Justification for choice of vehicle:
- Lot/batch no. (if required):
- Purity:

MAXIMUM DOSE VOLUME APPLIED:

DOSAGE PREPARATION (if unusual):

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:

Doses:

35.5 mL/kg, 28.4 mL/kg, 22.7 mL/kg, and 18.2 mL/kg

No. of animals per sex per dose:

10

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Results and discussion

Preliminary study:

A preliminary study had been conducted for the sample administration and determined the maximum dose of 44.4 mL/kg.

Effect levels

Effect levels 1

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

130.3 mg/kg bw

Based on:

test mat.

95% CL:

>= 118.5 - <= 142.2

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

130.5 mg/kg bw

Based on:

test mat.

95% CL:

>= 118.6 - <= 143.5

Mortality:

Death occurred from 3 hours after dosing in higher dose groups.

Clinical signs:

other: Decreased locomotory activity was observed from a few minutes after dosing across the dose levels.

Gross pathology:

Subsequent necropsy of animals that survived for 14 days showed mild hypertrophy of the spleen among major organs.

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

Under the conditions of this study it was found that 1-cyclohexyl-1H-pyrrole-2,5-dione should be classified as Acute toxicity cat 3 (oral).