(pentabromophenyl)methyl acrylate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

02/03/2012-04/04/2012

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:

2012

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 436 (Acute Inhalation Toxicity: Acute Toxic Class Method)

Deviations:

yes

Remarks:

only one dose level was conducted

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:

FR-1025M

IUPAC Name:

FR-1025M

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
- Analytical purity: 99.75%
- Lot/batch No.: 930070260
- Storage condition of test material: room temperature, in the dark

Test animals

Species:

rat

Strain:

other: RccHan: WIST

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon, UK
- Age at study initiation:8-12 weeks
- Weight at study initiation: 200-350g
- Housing: in groups of three by sex in solid-floor polypropylene cages with stainless steel lids, furnished with softwood flakes and provided with environmental enrichment items: wooden chew blocks and cardboard 'fun tunnels".
- 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): 12hrs light/12hrs dark

Administration / exposure

Route of administration:

inhalation: dust

Type of inhalation exposure:

nose only

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: chambers from ADG Developments Ltd., Hitchin, Herts, UK
- Exposure chamber volume: 30 litres
- Method of holding animals in test chamber: in a tapered, polycarbonate restraining tube
- Method of conditioning air: compressed air was passed through a water tap and respiratory quality filter
- System of generating particulates/aerosols:SAG 410 Solid Aerosol Generator (TOPAS GmbH, Dresden, Germany)
- Method of particle size determination: Marple Personal Cascade Impactor (Westech IS Ltd., Beds, UK)
- Temperature, humidity, pressure in air chamber: temperature and relative humidity were measured by an electronic thermometer/humidity meter (Hanna Instruments Ltd., Beds, UK)

TEST ATMOSPHERE
- Brief description of analytical method used: the gravimetric method used glass fibre filters placed in a filter holder. The holder was temporarily sealed in a vacant port in the exposure chamber in the animals' breathing zone and a suitable, known volume of exposure chamber air was drawn through the filter using a vacuum pump. Each filter was weighed before and after samling in order to calculate the weight of collected test item. The difference in the two weights, divided by the volume of atmosphere sampled, gave the actual chamber concentration.
- Samples taken from breathing zone: yes


TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: determined three times during the exposure period
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): MMAD = 2.80 μm, GSD = 2.22

CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration: 1.0mg/l as the mean achieved concentration was 102% of target and no deaths occured, no further levels were required.

Analytical verification of test atmosphere concentrations:

yes

Remarks:

by weight difference

Duration of exposure:

4 h

Concentrations:

1.0 mg/l

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:at hourly intervals during exposure, immediatly on removal from the restraining tubes at the end of exposure, one hour after termination of exposure 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:

LC50

Effect level:

> 1.02 mg/L air (analytical)

Based on:

test mat.

Mortality:

none

Clinical signs:

other: Signs of hunched posture, pilo-erection and red/brown staining around the snout are commonly seen in animals for short periods on removal from the chamber following 4-hour inhalation studies. Wet fur is commonly recorded during exposure. These observation

Body weight:

All male animals and two females exhibited slight bodyweight losses on the first day post-exposure. Reasonable bodyweight development was noted for all animals during the remainder of the recovery period.

Gross pathology:

No macroscopic abnormalities were detected

Other findings:

/

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Remarks:

Migrated information

Conclusions:

No deaths occured in a group of six rats exposed to a mean achieved atmosphere concentration of 1.02mg/L for four hours. It was therefore considered that the acute inhalation median lethal concentration (4hr LC50) of FR-1025M, in the RCCHan:WIST strain rat was greater than 1.02mg/L (GHS - Category 4, > 1-5mg/L.

Executive summary:

INTRODUCTION

A study was performed to assess the acute inhalation toxicity of the test item. The method was compatible with that described in the OECD No. 436, with the exception that only one dose level was conducted.

METHODS

A group of six RccHan:WIST strain rats (three males, three females) was exposed to a dust atmosphere. The animals were exposed for four hours using a nose only exposure system, followed by a fourteen day observation period.

RESULTS

The mean achieved atmosphere concentration was 1.02 mg/L (Std. Dev.: 0.05mg/L, nominal: 9.64 mg/L)

An example calculation for determining test atmosphere concentration is shown below:

Sample number	Time (mins)	Filter weights (mg)		Difference (mg)	Sample volume (L)	Concentration (mg/l)
		Pre-sample	Post-sample
1	5	32.57	36.61	4.04	4	1.01

The characteristics of the achieved atmosphere were as follows:

Mean achieved atmosphere concentration (mg/L)	Mean mass median aerodynamic diameter (µm)	Inhalable fraction (% < 4µm)	Geometric standard deviation
1.02	2.80	67.4	2.22