1-Ethoxy-2,3-difluoro-4-(trans-4-propylcyclohexyl)-benzene

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Mar 12 - May 15, 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

February 1987

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-ethoxy-2,3-difluoro-4-[(1s,4r)-4-propylcyclohexyl]benzene

EC Number:

605-718-3

Cas Number:

174350-05-1

Molecular formula:

C17H24F2O

IUPAC Name:

1-ethoxy-2,3-difluoro-4-[(1s,4r)-4-propylcyclohexyl]benzene

Test material form:

solid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: F. Winkelmann, Borchen, Germany
- Age at study initiation: 5 to 8 weeks
- Weight at study initiation: 172 (158 - 186) g
- Fasting period before study: 17 hours before until up to 4 hours after treatment
- Housing: separately in type III Makrolon cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 21
- Humidity (%): 54 to 68
- Photoperiod (hrs dark / hrs light): 12 hour light - 12 hour dark regime
IN-LIFE DATES: From: day 1 To: day 15

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Methocel K4M Premium solution

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 100 g/L
- Amount of vehicle (if gavage): 20 mL/kg bw
- Justification for choice of vehicle: excellent vehicle performance in long range historical data
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 (m) / 5 (f)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: for at least 6 hours after administration and then daily up to end of study
- Frequency of weighing: on days 2, 4, 6, 8, 11, 13, and 15 of the experimental part
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Statistics:

Standard statistical methods have been applied for data processing.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

All rats survived the observation period.

Clinical signs:

other: No signs of toxicity were seen in the 3 male and 3 female rats after treatment with 2000 mg/kg bw.

Body weight:

other body weight observations

Remarks:

On female rat showed inhibition of body weight development. The body weight development of the other rats was inconspicuous during the study.

Gross pathology:

The gross pathological examination revealed no organ alterations.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the result of this study, it is concluded that the test material has no acute toxic potential and that the LD50 value is higher than 2000 mg/kg bw after single oral administration in rats.

Executive summary:

The test material was tested for acute toxicity in rats after single oral administration of 2000 mg/kg body weight. The study was performed according to the OECD Guideline for Testing of Chemicals No. 401.

No signs of toxicity were seen in the rats (5 males, 5 females) after treatment with 2000 mg/kg bw of the test item. On female rat showed inhibition of body weight development. The body weight development of the other rats was inconspicuous during the study. There were no deaths during the course of the study. The gross pathological examination revealed no organ alterations.

Based on the result of this study, it is concluded that the test material has no acute toxic potential and that the LD₅₀ value is higher than 2000 mg/kg bw after single oral administration in male/female rats.