4-[4-trans-(3,4-Difluorophenyl)-cyclohexyl]-cyclohexanone

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2001-02-09 to 2001-03-29

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

03-1996

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

1996

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4-[4-trans-(3,4-Difluorophenyl)-cyclohexyl]-cyclohexanone

EC Number:

604-593-2

Cas Number:

147622-85-3

Molecular formula:

C18 H22 F2 O

IUPAC Name:

4-[4-trans-(3,4-Difluorophenyl)-cyclohexyl]-cyclohexanone

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 7 - 9 weeks
- Weight at study initiation: 162 - 178 g
- Fasting period before study: 17 hours prior to dosing until 4 hours after treatment
- Housing: separately in Makrolon type III cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 22
- Humidity (%): 50 - 55
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: Days 1 to 15

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

methylcellulose

Remarks:

Methocel(R) K4M Premium solution

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 100 g/L
- Volume applied: 20 mL/kg

Doses:

2000 mg/kg

No. of animals per sex per dose:

3 m / 3 f

Control animals:

no

Details on study design:

-Duration of observation period following administration: 14 days
-Frequency of observations: at least 6 hours after administration and then daily
-Frequency of weighing: before treatment and on study days 2, 4, 6, 8, 11, 13 and 15
-Necropsy of survivors performed: yes

Statistics:

Standard statistical methods were applied

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 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 toxicity were seen in dosed rats

Body weight:

Body weight development of treated and control rats was normal

Gross pathology:

The gross pathological examination revealed no organ alterations

Any other information on results incl. tables

Study design

In this GLP study performed according to the OECD GL 423 the test item was tested for acute toxicity in rats after single oral administration of 2000 mg/kg body weight. Directly before administration the test material was prepared with aqueous Methocel K4M Premium solution as the vehicle.

Results

No signs of toxicity and no deaths during the course of the study were seen in dosed rats. The gross pathological examination revealed no organ alterations.

Conclusion

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 after single oral administration in rats.

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 after single oral administration in rats.

Executive summary:

This study was performed according to GLP and is fully compliant OECD GL 423. 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 after single oral administration in rats.