Reaction mass of 1,1'-(isopropylidene)bis[3,5-dibromo-4-(2,3-dibromo-2-methylpropoxy)benzene] and 1,3-dibromo-2-(2,3-dibromo-2-methylpropoxy)-5-{2-[3,5-dibromo-4-(2,3,3-tribromo-2-methylpropoxy)phenyl]propan-2-yl}benzene

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Few details on materials and methods were given, the individual animal data was not reported, no necropsy was performed, the airflow was not monitored, air changes per minute were not reported, the type of inhalation exposure was not specified. The requirements of the listed guideline were not available.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: The Guidelines for the Testing of Chemicals (State Environmental Protection Administration of China) 2004.5

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: The Guidelines for the Hazard Evaluation of New Chemical Substances (HJ/T 154-2004)

Deviations:

no

Test guideline 3

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Version / remarks:

adopted Sep 2009

Deviations:

yes

Remarks:

few details on materials and methods were given, individual animal data not reported, no necropsy was performed, air changes per minute not reported, airflow was not monitored, the type of inhalation exposure not specified

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,1'-(isopropylidene)bis[3,5-dibromo-4-(2,3-dibromo-2-methylpropoxy)benzene]

EC Number:

306-832-3

EC Name:

1,1'-(isopropylidene)bis[3,5-dibromo-4-(2,3-dibromo-2-methylpropoxy)benzene]

Cas Number:

97416-84-7

Molecular formula:

C23H24Br8O2

IUPAC Name:

1,1'-(isopropylidene)bis[3,5-dibromo-4-(2,3-dibromo-2-methylpropoxy)benzene]

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals

Species:

rat

Strain:

other: SPF Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Vital River Laboratory Animal Technology Co. Ltd., Beijing, China
- Weight at study initiation: 252.2 ± 1.9 g (females) and 258.0 ± 4.9 g (males)
- Housing: animals were housed individually
- Diet: rodent feed (HFK BIOSCIENCE Co., Ltd., Beijing, China), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 25
- Humidity (%): 55 ± 15
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

inhalation: dust

Type of inhalation exposure:

not specified

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Dynamic inhalation control system (HOPE-MED8051C), solid phase dust inhalation chamber (8051) and automatic dust dynamic control system (8051C) (Tianjin HOPE Co., Ltd., Tianjin, China); dust sampler and filter membrane (Yancheng Kebo Electron Instrument Co., Ltd., Jiangsu, China)
- Exposure chamber volume: 300 L
- Source and rate of air: 4.0 m³/h
- System of generating particulates/aerosols: dust of the test substance was generated with the dust generator and entered the inhalation chamber at a rate of 2.8 mL/min.

TEST ATMOSPHERE
- Brief description of analytical method used: gravimetric method. Samples of the test substance were collected at 1, 2 and 3 h using a dust sampler equipped with a filter membrane that had been weight prior to sampling. The weight minus filter weight was used as the sample weight.

Analytical verification of test atmosphere concentrations:

yes

Remarks:

gravimetric method

Duration of exposure:

4 h

Concentrations:

5 mg/L (nominal concentration)
5.47 mg/L (analytical concentration)

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: the animals were observed for mortality and clinical signs immediately after exposure, and daily thereafter for the rest of the study period; the body weight was recorded on Day 0 (prior to dosing), 7 and 14
- Necropsy of survivors performed: no

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.47 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: No clinical signs of toxicity were observed during the 14-day observation period.

Body weight:

The body weight gains were within the normal ranges in males and females during the whole study period.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

CLP: not classified