4-ethoxy-2,3-difluoro-4'-propyl-1,1'-biphenyl

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2011-04-12 to 2011-05-17

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

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-ethoxy-2,3-difluoro-4'-propyl-1,1'-biphenyl

EC Number:

638-734-4

Cas Number:

157248-24-3

Molecular formula:

C₁₇H₁₈F₂O

IUPAC Name:

4-ethoxy-2,3-difluoro-4'-propyl-1,1'-biphenyl

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: Charles River Wiga GmbH, Kißlegg, Germany
- Age at study initiation: 7 weeks (m) 9 weeks (f)
- Weight at study initiation: 159 (152 - 170) 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, tap water
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 to 23
- Humidity (%): 52 to 64
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: day 1 To: day 15

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Methocel KM4 Premium solution

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 g/L
- Amount of vehicle: 10 mL/kg bw
- Justification for choice of vehicle: excellent vehicle performance in long range historical data

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw

DOSAGE PREPARATION: Directly before administration the test material was prepared with aqueous Methocel K4M Premium solution as vehicle using a Vortex Genie 2 and an Ultra-Turrax device.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 (m) / 3 (f)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: before treatment and 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:

The body weight development was inconspicuous throughout the study.

Gross pathology:

At necropsy, no organ alterations were seen.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material showed no acute toxic potential and the LD50 value was determinded to be higher than 2000 mg/kg 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 GLP compliant study was performed according to the OECD Guideline for Testing of Chemicals, No. 423. There were no deaths during the course of the study. No signs of toxicity were seen in the rats (3 males, 3 females) after treatment with 2000 mg/kg bw of the test item. The body weight development of the rats was inconspicuous during 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 rats.