1-[4-(4-chlorophenoxy)-2-(trifluoromethyl)phenyl]ethanone

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2014-11-04 to 2014-12-03

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

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:

17 December 2001

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

December 2002

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: Japan MAFF 8147

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Bioassay GmbH, Im Neuenheimer Feld 515-519, 69120 Heidelberg, Germany

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1-[4-(4-chlorophenoxy)-2-(trifluoromethyl)phenyl]ethanone

EC Number:

813-142-0

Cas Number:

1417782-28-5

Molecular formula:

C15 H10 Cl F3 O2

IUPAC Name:

1-[4-(4-chlorophenoxy)-2-(trifluoromethyl)phenyl]ethanone

Test material form:

solid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- batch No.of test material: L85-76
- Expiration date of the lot/batch: October 01, 2016

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Storage Stability: The stability of the test item under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Crl:WI (Han) SPF

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: Young adult animals (female animals approx. 10 weeks)
- Weight at study initiation: 185 - 194 g (mean 190.7 g)
- Fasting period before study: at least 16 hours
- Housing: Single housing
- Diet: ad libitum, VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany
- Water: ad libitum, tap water
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: undiluted or 20 g/100 mL
- Amount of vehicle: 1.52 mL/kg bw if administered undiluted and 1.50 mL/kg bw at a dose of 300 mg/kg bw.
- Justification for choice of vehicle: Solution in corn oil Ph.Eur.

MAXIMUM DOSE VOLUME APPLIED: 1.52 mL/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Request of the sponsor

Doses:

300 and 2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations daily; weighing weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred in both 2000 mg/kg bw test groups and in the single 300 mg/kg bw test group.

Clinical signs:

Clinical signs in the first 2000 mg/kg test group revealed in all animals impaired general state and piloerection from hour 2 until hour 4 after administration. These findings were seen again in one animal on day 1, in another animal from hour 5 until day 1. Additionally cowering position was observed in one animal from hour 4 until hour 5 only.
Clinical signs in the second 2000 mg/kg test group revealed in all animals impaired general state and piloerection from hour 2 until hour 5. In one animal these findings persisted until study day 2 after administration.
Clinical signs in the single 300 mg/kg test group revealed in all animals impaired general state and piloerection from hour 2 until hour 3 or/and 5 after administration.

Body weight:

The mean body weight of all test groups increased throughout the study period within the normal range.

Gross pathology:

There were no macroscopic pathological findings in all animals sacrificed at the end of the observation period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met