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

Endpoint summary

Description of key information

LD50 (oral) > 2000 mg/kg bw (BASF SE, 10A0500/14X245, 2015)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

17 December 2001

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

December 2002

Deviations:

no

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

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.

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

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

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.

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Additional information

In an acute oral toxicity study performed according to the Acute Toxic Class method (OECD guideline 423), doses of 2000 and 300 mg/kg of the test item (undiluted or preparations in corn oil Ph. Eur.) were administered by gavage to three test groups of three fasted Wistar rats each (2000 mg/kg bw in 6 females, 300 mg/kg bw in 3 females).

No mortality was observed throughout the study period. Clinical signs observed within the first two days after administration included an impaired general state and piloerection in all animals of the 2000 mg/kg bw and 300 mg/kg bw dosing group. One animal showed a cowering position at 2000 mg/kg bw. The mean body weight of all animals increased within the normal range throughout the study period. There were no macroscopic pathological findings in the animals which were sacrificed at the end of the observation period (9 females). The acute oral LD50 was calculated to be above 2000 mg/kg bw.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. The LD50 was greater than 2000 mg/kg bw. As a result the substance is not considered to be classified for acute oral toxicity under Regulation (EC) No. 1272/2008, as amended for the ninth time in Regulation (EU) No 2016/1179.