Bromobenzene

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 Nov 1980 - 4 Feb 1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

(no GLP, not according to guideline)

Data source

Reference

Reference 1

Reference Type:

publication

Title:

The Effects of Fasting on the Acute Oral Toxicity of Nine Chemicals in the Rat

Author:

Dashiell, O.L. and Kennedy, G.L.

Year:

1984

Bibliographic source:

J. Appl. Toxicol. 4(6):320-325

Reference 2

Reference Type:

publication

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

- Principle of test: Single oral dose administration of three doses of bromobenzene administered to fasted and non-fasted rats
- Short description of test conditions: 10 males per dose were treated and observed for 14 - 16 days
- Parameters analysed / observed: mean time of death, clinical signs, mean body weight change from day 1 to 14, LD50

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Bromobenzene

EC Number:

203-623-8

EC Name:

Bromobenzene

Cas Number:

108-86-1

Molecular formula:

C6H5Br

IUPAC Name:

bromobenzene

Test material form:

liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source of test material: Fischer Chemicals, Fairlawn, NJ, USA

Test animals

Species:

rat

Strain:

other: Crl-CD

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Breeding Laboratory, North Wilmington, MA, USA
- Age at study initiation: Approx. 60 days
- Weight at study initiation: 220 - 280 g
- Fasting period before study: Yes, groups of fasted (24 h) and non-fasted animals were dosed
- Diet: Purina Rat Chow (Ralston Purina Co., St Louis, USA), ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 10 - 25%

MAXIMUM DOSE VOLUME APPLIED: 4.5 mL

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Dose levels were selected based on a range-finding study to deine a dose producing mortality.

Doses:

fasted animals: 2000, 2800 and 3500 mg/kg
non-fasted: 3000, 3500 and 4000 mg/kg

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 - 16 days
- Frequency of weighing: Individual body weights were determined on Days 0, 1 and 14
- Necropsy of survivors performed: no
- Other examinations performed: mortality, clinical signs, body weight

Statistics:

LD50 values were determined by Probit analysis (Finney, 1971).

Results and discussion

Preliminary study:

One rat was treated with 670 - 7500 mg/kg bw to roughly define the dose producing mortality. Mortality was observed starting at 3400 mg/kg bw.

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

3 591 mg/kg bw

Based on:

test mat.

Remarks on result:

other: non-fasted rats

Effect levels 2

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

2 383 mg/kg bw

Based on:

test mat.

Remarks on result:

other: fasted rats

Mortality:

Fasted animals
2000 mg/kg: 3/10 animals died
2800 mg/kg: 6/10 animals died
3500 mg/kg: 10/10 animals died

Non-fasted animals
3000 mg/kg: 1/10 animals died
3500 mg/kg: 4/10 animals died
4000 mg/kg: 8/10 animals died

Clinical signs:

other: Fasted animals All doses: stained and wet perineal area, stained face, lacrimation, chromodacryorrhea, diarrhea and congestion 2000 mg/kg: weakness 2800 mg/kg: weakness, lethargy, prostration 3500 mg/kg: salvation, tremors, prostration Non-fasted animals

Gross pathology:

Not performed

Any other information on results incl. tables

Table 1: Results of acute oral toxicity study

Dose [mg/kg]	Mortality (of 10 treated)	Day of death^a	Weight decrease day 0-1 [g]^a	Weight increase day 0-14 [g]^a
Fasted
2000	3	2 ± 1	7 ± 2	36 ± 4
2800	6	2 ± 1	8 ± 1	40 ± 2
3500	10	2 ± 1	5 ± 2	-
Non-fasted
3000	1	3 ± 0	11 ± 3	17 ± 4
3500	4	2 ± 1	9 ± 4	16 ± 4
4000	8	3 ± 2	12 ± 2	20 ± 3

a: mean ± SD

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