Benzene, 4-bromo-1-chloro-2-[(4-ethoxyphenyl)(phenylmethoxy)methyl]-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 22 Apr to 07 May 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study run to a method comparable with current guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Details on test material:

Batch No.: 92346A001A
Purity: >98%

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage JANVIER Labs
- Age at study initiation: 8 weeks old
- Weight at study initiation: between 169 g and 218 g
- Fasting period before study: an overnight
- Housing: Healthy female rats were housed by group of three in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid. Each cage contains sawdust bedding which was changed at least 2 times a week.
- Diet (e.g. ad libitum): Free access to foodstuff. Food was removed on D-1 and then redistributed 4 hours after the test item administration.
- Water (e.g. ad libitum): Free access to tap-water from public distribution system
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 °C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least ten changes
- Photoperiod (hrs dark / hrs light): twelve hours continuous light (07:00 to 19:00) and twelve hours darkness

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

DMSO

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg

DOSAGE PREPARATION (if unusual): In the first and second step of the study, 2.0015 g and 2.0035 g of the test item, was weighed and dimethyl sulfoxide was added to two 10 mL volumetric flasks, respectively. The preparations were magnetically stirred to obtain a red solution just before the administration.

Doses:

2000 mg/kg

No. of animals per sex per dose:

Step 1: 3 female rats
Step 2: 3 female rats

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Systematic examinations were carried out every day to identify any behavioral or toxic effects on the major physiological functions during 14 days following the administration of the test item. The animals were weighed on day 0 (just before administering the test item) then on D2, D7, and D14.
- Necropsy of survivors performed: yes, On D14, the animals were anaesthetised with sodium pentobarbital and administration continue to fatal levels. Macroscopic observations were entered on individual autopsy sheets. Only those organs likely to be modified in cases of acute toxicity were examined. Those presenting macroscopic anomalies can be removed and preserved in view to microscopic examinations.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study.

Clinical signs:

other: No clinical signs related to the administration of the test item were observed during the study.

Gross pathology:

The macroscopic examination of the animals at the end of the study did not reveal treatment related changes.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of the test item is higher than 2000 mg/kg body weight by oral route in the rat. In accordance with the OECD guideline No. 423, the LD50 cut-off of the test item may be considered to be higher than 5000 mg/kg body weight by oral route in the rat.
According to the criteria for classification, packaging and labeling of dangerous substances and preparations in accordance with the E.E.C. Directives 67/548, 2001/59 and 99/45, the test item must not be classified, according to the criteria for classification, packaging and labeling of dangerous substances and preparations in compliance with the E.E.C. Directives 67/548, 2001/59 and 99/45. No symbol or risk phrase is required.
In accordance with the Regulation (EC) No. 1272/2008, the test item must hat be classified. No signal word or hazard statement is required.