4-trans-Propyl-4-trans-(3,4,5-trifluorphenyl)-[1,1-bicyclohexyl]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August 27, 1991 - December 2, 1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

OECD 1981, updated Guideline adopted February 24, 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:

4-trans-Propyl-4-trans-(3,4,5-trifluorphenyl)-[1,1-bicyclohexyl]

EC Number:

603-522-2

Cas Number:

131819-23-3

Molecular formula:

C21H29F3

IUPAC Name:

4-trans-Propyl-4-trans-(3,4,5-trifluorphenyl)-[1,1-bicyclohexyl]

Test material form:

solid

Specific details on test material used for the study:

Batch: E828954

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Thomae, Biberach, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 7 to 9 weeks
- Weight at study initiation: 179 g (170 - 189 g)
- Fasting period before study: 18 hours before until up to 4 hours after treatment
- Housing: separately in type III Makrolon cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 - 25°C
- Humidity (%): 42-58%
- 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:

methylcellulose

Remarks:

Methocel K4M Premium solution

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 250 g/L
- Amount of vehicle (if gavage): 20 mL/kg
- Justification for choice of vehicle: well tolerated and established standard vehicle

Doses:

5000 mg/kg

No. of animals per sex per dose:

5 (m) / 5 (f)

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: day 1, 2, 4, 6, 8, 11, 13 and 15
- 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:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

All rats survived the observation period.

Clinical signs:

No signs of intoxication were observed after treatment.

Body weight:

Body weight development of treated rats was normal.

Gross pathology:

In the rats, which were all sacrified at the end of the observation period, no organ alterations were seen.

Any other information on results incl. tables

Study design

The test material was tested for acute toxicity in rats after single oral administration of 5000 mg/kg body weight. Directly before administration the test material was prepared with aqueous Methocel K4M Premium solution as the vehicle. The study was performed according to the OECD Guideline for Testing of Chemicals, No. 401.

Results

No signs of intoxication were observed after treatment. A limit test (5000 mg/kg) showed no mortality, and thus there was no need for a LD50 determination and calculation.

Conclusion

For regulatory purposes, the median lethal dose (LD50) for males and females, after an observation period of 15 days, may be listed as >5000 mg/kg.

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 5000 mg/kg after single oral administration in rats.

Executive summary:

This study was performed according to GLP and is fully compliant OECD TG 401. 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 5000 mg/kg after single oral administration in rats.