Bromoform

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

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

Data source

Reference

Reference Type:

publication

Title:

The Acute Toxicity of Four Trihalomethanes in Male and Female Rats

Author:

Chu. I., Secours, V., Marino, I., and Villeneuve, D.C.

Year:

1980

Bibliographic source:

Toxicology and Applied Pharmacology 52, 351-353 (1980)

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Although no guideline is mentioned in the publication the method follows the classical LD50 test.

GLP compliance:

no

Test type:

other: Although no guideline is mentioned in the publication the method follows the classical LD50 test

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Bromoform

EC Number:

200-854-6

EC Name:

Bromoform

Cas Number:

75-25-2

Molecular formula:

CHBr3

IUPAC Name:

tribromomethane

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Aldrich Chemiclas, Milwaukee, Wis.
- Purity: 96%
- Impurity: 3% chlorodibromomethane, 1% not stated.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Biobreeding Labs., Ottawa, Ontario.
- Females (if applicable) nulliparous and non-pregnant: Not stated.
- Age at study initiation: Not stated
- Weight at study initiation: 150-200g (start of acclimation)
- Fasting period before study: Fasted overnight before dosing
- Housing: Not stated.
- Diet (e.g. ad libitum): Not stated.
- Water (e.g. ad libitum): Not stated.
- Acclimation period: One week.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2 °C
- Humidity (%): 40 - 60%
- Air changes (per hr): Not stated.
- Photoperiod (hrs dark / hrs light): Not stated.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: Not specified
- Amount of vehicle (if gavage): 2 ml/kg

MAXIMUM DOSE VOLUME APPLIED: 2 ml/kg

Doses:

Range-finding:

To establish the dose levels to be used in the LD5O studies, groups of two animals were administered test compounds at 250-3000 mg/kg and the mortality data were recorded.

Main study doses:

546 mg/kg
765 mg/kg
1071 mg/kg
1500 mg/kg
2100 mg/kg

No. of animals per sex per dose:

10 males and 10 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Statistics:

Median lethal dose (LD50) was calculated using the probit analysis.

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

1 388 mg/kg bw

Based on:

test mat.

95% CL:

>= 1 167 - <= 1 693

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

1 147 mg/kg bw

Based on:

test mat.

95% CL:

>= 890 - <= 1 524

Mortality:

Number of dead animals per group:

546 mg/kg = 1/20
765 mg/kg = 5/20
1071 mg/kg = 5/20
1500 mg/kg = 9/20
2100 mg/kg = 20/20

Clinical signs:

other: Hypothermia was observed, but dose levels not stated.

Gross pathology:

Livers and kidneys were reported to be congested and enlarged at necropsy, but no dose response information was reported.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The acute oral LD50 of the test substance in Sprague-Dawley rats was 1388 and 1147 mg/kg bw in males and females respectively.

Executive summary:

Introduction

The acute oral toxicity of the test substance to Sprague-Daawley rats. No guideline was followed but the study used a method similar to the classical LD50 test.

Method

To establish the dose levels to be used groups of two animals were administered test compounds at 250-3000 mg/kg and the mortality data were recorded and used ot det dosew in the main test. For the main test five doses between 546 and 2100 mg/kg were employed and 10 males and 10 females used at each dose level. Dosing solutions were administered to animals in corn oil using premature infant feeding tubes (8 Fr., 15 in. length) at a maximum volume of 2ml/kg. Clinical observations were made for 14 days after dosing and a post-mortem examination was performed on animals which died during this period. All surviving animals were killed at the end of 14 days and subjected to gross pathologic examination.

Results and Conclusion

The acute oral LD50 of the test substance in Sprague-Dawley rats was 1388 and 1147 mg/kg bw in males and females respectively.