4-ethoxybenzoic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

Data is from secondary source

Data source

Reference

Reference Type:

secondary source

Title:

Initial Submission: Toxicity Studies with Cyclohexene with Cover Letter DATED 082492

Author:

Eastman Kodak Co

Year:

1992

Bibliographic source:

NTRL, OTS0546026, 08/27/92

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as below

Principles of method if other than guideline:

Acute oral toxicity study of Cyclohexene in mice

GLP compliance:

not specified

Test type:

other: not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Cyclohexene

Cas Number:

110-83-8

Molecular formula:

C6H10

IUPAC Name:

Cyclohexene

Details on test material:

- Name of test material (as cited in study report): Cyclohexene
- Molecular formula (if other than submission substance): C6H10
- Molecular weight (if other than submission substance): 82.145 g/mole
- Substance type: Organic
- Physical state: Liquid

Specific details on test material used for the study:

- Name of test material (as cited in study report): Cyclohexene
- Molecular formula (if other than submission substance): C6H10
- Molecular weight (if other than submission substance): 82.145 g/mole
- Substance type: Organic
- Physical state: Liquid

Test animals

Species:

mouse

Strain:

ICR

Remarks:

Royalhart

Sex:

male

Details on test animals or test system and environmental conditions:

No data available

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 162, 324, 649, 1298 and 2595 mg/kg bw
- Amount of vehicle (if gavage): No data available
- Justification for choice of vehicle: No data available
- Lot/batch no. (if required): No data available
- Purity: No data available

MAXIMUM DOSE VOLUME APPLIED: No data available

DOSAGE PREPARATION (if unusual): The compound was delivered in pure form.

Doses:

162, 324, 649, 1298 and 2595 mg/kg bw

No. of animals per sex per dose:

Total : 20
162 mg/kg bw: 4 male
324 mg/kg bw: 4 male
649 mg/kg bw: 4 male
1298 mg/kg bw: 4 male
2595 mg/kg bw: 4 male

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Behavior of the• animals were observed frequently for the first day and then four (4) times daily for a period of fourteen (14) days.
- Necropsy of survivors performed: yes
- Other examinations performed: Mortality, clinical signs and gross pathology were observed

Statistics:

No data available

Results and discussion

Preliminary study:

No data available

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 595 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No 50 % mortality observed

Mortality:

When treated with 2595 and 649 mg/kg bw, one animal of each dose group died on day 1 of treatment.

Clinical signs:

other: When treated with 2595 mg/kg bw, Depression, ataxia and loss of righting reflexes were observed.

Gross pathology:

When treated with 2595 mg/kg bw, pale kidneys were observed in one mice.

Other findings:

No data available

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

LD50 was considered to >2595 mg/kg bw when Royalhart lCR male mice were treated with Cyclohexene orally.

Executive summary:

In a acute oral toxicity study,Royalhart lCR male mice were treated with Cyclohexene in the concentration of 162, 324, 649, 1298 and 2595 mg/kg bw orally. At 2595 and 649 mg/kg bw, one animal of each died on day 1 of treatment. At 2595 mg/kg bw, Depression, ataxia and loss of righting reflexes were observed. Pale kidneys were observed in one mice at 2595 mg/kg bw. Therefore,LD50 was considered to be >2595 mg/kg bw when Royalhart lCR male mice were treated with Cyclohexene orally.