(pentabromophenyl)methyl acrylate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

03/04/2003-29/05/2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP comparable to OECD guideline

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

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)

Principles of method if other than guideline:

/

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

(pentabromophenyl)methyl acrylate

EC Number:

261-767-7

EC Name:

(pentabromophenyl)methyl acrylate

Cas Number:

59447-55-1

Molecular formula:

C10H5Br5O2

IUPAC Name:

(2,3,4,5,6-pentabromophenyl)methyl prop-2-enoate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report):FR-1025M
- Substance type:Monomer
- Physical state:white powder
- Lot/batch No.: 020313
- Storage condition of test material: room temperature in the dark

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd., Margate, Kent, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: within an interval of +/-20% of the mean initial bodyweight of the first treated group except for animal number 5-2 whose bodyweight was approximately +22% of the mean initial bodyweight of the first treated group. This deviation was considered not to affect the purpose or integrity of the study.
- Fasting period before study: an overnight fast immediately before dosing and for approximately 3-4 hours after dosing
- Housing: in groups in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):19-25°C
- Humidity (%):30-70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light):12 hrs dark/12hrs light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle:5, 30, 200, 200, 500 mg/ml
- Amount of vehicle (if gavage): calcultated according to the fasted bodyweight at the time of dosing.


MAXIMUM DOSE VOLUME APPLIED: 10


CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: using all available information on the toxicity of the test material, 50mg/kg was chosen at the starting dose.

Doses:

50, 300, 2000, 2000, 5000 mg/kg

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: 2, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, necropsy, mortality

Statistics:

/

Results and discussion

Preliminary study:

/

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

no deaths

Clinical signs:

other: no signs of systemic toxicity

Gross pathology:

No abnormalities were noted at necropsy

Other findings:

/

Applicant's summary and conclusion

Conclusions:

The acute oral medial lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated as being greater than 5000mg/kg bodyweight.

Executive summary:

Introduction.

The study was performed to assess the acute oral toxicity of the test material following a single oral administration in the Sprague-Dawley CD strain rat. The method was designed to meet the requirements of the following:

• OECD Guidelines for the Testing of Chemicals No. 423 “Acute Oral Toxicity – Acute Toxic Class Method” (adopted 17 December 2001)
• United States Enviro

nmental Protection Agency Health Effects Test Guidelines OPPTS 870.1100 Acute Oral Toxicity, 2002

Method.

A group of three fasted females was treated with the test material at a dose level of 50 mg/kg bodyweight. Based on the results from this dose level further groups of fasted females were treated at dose levels of 300, 2000 and 5000 mg/kg bodyweight. Dosing was performed sequentially. The test material was administered orally as a suspension in arachis oil BP. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

Mortality. There were no deaths.

Clinical Observations. There were no signs of systemic toxicity.

Bodyweight. All animals showed expected gains in bodyweight over the study period.

Necropsy. No abnormalities were noted at necropsy.

Conclusion. The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated as being greater than 5000 mg/kg bodyweight.