(pentabromophenyl)methyl acrylate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

09/04/2003-23/4/2003

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 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Principles of method if other than guideline:

/

GLP compliance:

yes (incl. QA statement)

Limit test:

yes

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:

male/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: 200g
- Housing: 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 light, 12hrs dark

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

arachis oil

Details on dermal exposure:

TEST SITE
- Area of exposure: back and flank
- % coverage: 10%
- Type of wrap if used: surgical gaze and semi-occluded with a piece of self-adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with cotton wool moistened with distilled water to remove any residual test material.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000mg/kg
- Constant volume or concentration used: yes

Duration of exposure:

24h

Doses:

5000mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1/2, 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

Statistics:

/

Results and discussion

Preliminary study:

/

Effect levels

Sex:

male/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

Other findings:

Dermal reaction: no signs of dermal irritation

Applicant's summary and conclusion

Conclusions:

The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was found to be greater than 5000mg/kg bw

Executive summary:

INTRODUCTION

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

* OECD 402

* EU method B3

* OPPTS 870.1200

METHOD

A group of ten animals was given a single, 24 -hour, semi-occluded dermal application of undiluted test material to intact skin at a dose level of 5000mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

MORTALITY: There were no deaths

CLINICAL OBSERVATIONS: no signs of systemic toxicity

DERMAL IRRITATION: no signs of dermal irritation

BODYWEIGHT: all animals showed expected gains in bodyweight over the study period, except for one female treated at a dose level of 5000mg/kg that showed a bodyweight loss during the first week and expected gain in bodyweight over the second week.

NECROPSY: no abnormalities were noted at necropsy

CONCLUSION: The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was found to be greater than 5000mg/kg bodyweight.