Bromobenzene

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:

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

Justification for type of information:

Please refer to analogue justification provided in IUCLID section 13

Data source

Reference

Reference Type:

publication

Title:

The Inhalation Hazard Test; principle and method

Author:

Klimisch, H.-J.

Year:

1988

Bibliographic source:

Arch Toxicol 61:411 - 416

Materials and methods

Principles of method if other than guideline:

The acute toxic potential following inhalation was determined according to the Inhalation Hazard Test. Animals were exposed to a fixed concentration (66 mg/L) and the time after which no or 50% of test animals dies was determined.

GLP compliance:

no

Test type:

other: Inhalation Hazard Test

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Chlorobenzene

EC Number:

203-628-5

EC Name:

Chlorobenzene

Cas Number:

108-90-7

Molecular formula:

C6H5Cl

IUPAC Name:

chlorobenzene

Test material form:

liquid

Test animals

Species:

other: not specified

Strain:

not specified

Sex:

male/female

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: whole-body exposure system (only general information given)
- Exposure chamber volume: 1 - 2L
- System of generating particulates/aerosols: Glass flask generator. The part of the generator containing the glass fritt and filled with the test substance dips into a thermostated liquid bath kept at the 20 °C
- Temperature in air chamber: saturation temperature (e.g. 20 °C)

Analytical verification of test atmosphere concentrations:

yes

Remarks:

gravimetrically from the weight loss of the material and the volume of air passing through the generator

Concentrations:

66 mg/L (saturated vapour pressure at 20 °C)

No. of animals per sex per dose:

3

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

other: LT50

Effect level:

66 mg/L air (nominal)

Based on:

test mat.

Exp. duration:

1.8 h

Remarks on result:

other: Exposure for 1.8 h to 66 mg/L test substance resulted in mortality of 50% of test animals within the 14 day observation period.

Effect levels 2

Sex:

male/female

Dose descriptor:

other: LT0

Effect level:

66 mg/L air (nominal)

Based on:

test mat.

Exp. duration:

0.17 h

Remarks on result:

other: Exposure for 0.17 h to 66 mg/L test substance did not result in any mortality within the 14 day observation period.

Effect levels 3

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

29.7 mg/L air (nominal)

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: Calculation according to Haber`s law (C∙t = k)

Mortality:

66 mg/L: 3/6 animals died after exposure for 1.8 h

Clinical signs:

other: not examined

Body weight:

not examined

Gross pathology:

not examined

Any other information on results incl. tables

The Inhalation Hazard Test was performed to determine the hazard of volatile substances including chlorobenzene. 3 male and 3 female animals were exposed to 66 mg/L (nominal concentration) in a glass system with tubes.

For the generation of a vapor saturated inhalation atmosphere, a glass flask generator was used. The LT0 (time T after which no animals died within 14 days of post-exposure observation period) and the LT50 (time of exposure after which 50% of the animals died within 14 days of the post-exposure observation period) were calculated.

In this inhalation hazard test, the value of LT0 was 0.17 h and the value of LT 50 was 1.8 h.

The LC50 was calculated according to the Haber´s law: LC50= 66 mg/L  (1.8 h /4 h) = 29.7 mg/L.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

CLP: Acute Tox. 4, H332
Although available data on acute toxicity following inhalation do not meet the classification criteria according to Regulation (EC) 1272/2008, the registrant follows the harmonised classification.