1-[5-(3-chloro-2-fluorobenzyl)-2,4-dimethoxyphenyl]ethanone

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

16/06/2011-06/07/2011

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

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: Commission Regulation (EC) N.440/2008, L142, Annex Part B, 30 May 2008

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: EPA Health Effects Test Guidelines, OPPTS 870.1000 Acute toxicity testing background

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

The animals were derived from a controlled full-barrier maintained breeding system (SPF). According to Art. 9.2, No.7 of the German Act on Animal Welfare (10) the animals were bred for experimental purposes.

TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8-10 weeks old
- Weight at study initiation: step 1/ animals N.1-3: 160-165 g; step 2/ animals N.4-6: 159-180 g
- Housing: Full barrier in an air-conditioned room
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): free access
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 3°C
- Humidity (%): 55+/- 10%
- Air changes (per hr): 10 x / hour
- Photoperiod (hrs dark / hrs light): artificial light, 12/ 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

cotton seed oil

Doses:

Dose: 2000 mg/kg bw
The test item was suspended in the vehicle cottonseed oil at a conc. of 0.2 g/ml and administered at a dose V of 10 mL/kg.

No. of animals per sex per dose:

3 per step

Control animals:

yes

Details on study design:

All animals were observed for 14 days after dosing for general clinical signs, morbidity and mortality

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

All animals survived until the end of the study.

Clinical signs:

No signs of toxicity.

Body weight:

The body weight gain of the test animals was within the normal range of variation.

Gross pathology:

No specific gross pathological changes were recorded for any animal.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the present study, a single oral application of the test item (ELV)DIMETOSSIACETOFENONE to rats at a dose of 2000 mg/kg bw was associated with no signs of toxicity or mortality.
The LD50 after a single oral administration to female rats, observed over a period of a 14 days is > 2000 mg/kg bw.
According to Annex I of Reg. 1272/2008 EC the test item is not classified.