Difluoroacetic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

publication

Title:

Acute Spermatogenic Effects of Bromoacetic Acids

Author:

RALPH E. LINDER, GARY R. KLINEFELTER, LILLIAN F. STRADER, JUAN D. SUAREZ, AND CHERYL J. DYER

Year:

1994

Bibliographic source:

FUNDAMENTAL AND APPLIED TOXICOLOGY 22, 422-430 (1994)

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other:

Principles of method if other than guideline:

The subacute study was conducted to evaluate the toxic effects of repeated dose toxicity of dibromoacetic acid (DBA) in male Sprague-Dawley rats.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Dibromoacetic acid

EC Number:

211-165-5

EC Name:

Dibromoacetic acid

Cas Number:

631-64-1

IUPAC Name:

dibromoacetic acid

Test material form:

other: Liquid

Details on test material:

- Name of test material (as cited in study report): DIBROMOACETIC ACID
- Molecular formula (if other than submission substance): C2H2Br2O2
- Molecular weight (if other than submission substance): 217.86
- Substance type: Organic
- Physical state: Liquid
Purity ----

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male

Details on test animals or test system and environmental conditions:

-Source: Harlan Sprague—Dawley Inc
-Age: 3.5 to 4 months
-Housing: rats caged 2 per cage
-Water: No data
-Diet: No data
- Acclimation period: No data


ENVIRONMENTAL CONDITIONS:
Temperature: 22 ± 1°C;
Humidity (%):50 ± 10%.
Photoperiod: 12 h light/dark,

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: No data
- Amount of vehicle (if gavage): No data
- Justification for choice of vehicle: No data
- Lot/batch no. (if required): No data
- Purity: No data

MAXIMUM DOSE VOLUME APPLIED : No data

DOSAGE PREPARATION (if unusual):
The compounds were dissolved in distilled water and the solutions adjusted dropwise with NaOH to approximately pH 6.5 to reduce acidity for oral dosing and guard against deterioration of the compound in alkaline solution. The concentrations were adjusted to deliver the required dosage in a volume of 5 (MBAA) or 10 ml/kg (DBAA).


CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: No data

Doses:

0, 1000, 2000 mg/kg

No. of animals per sex per dose:

Control: 5 males
1000 mg/kg: 5 males
2000 mg/kg: 5 males

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Necropsy of survivors performed: no
- Other examinations performed:

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

1 737 mg/kg bw

Based on:

test mat.

Remarks on result:

other: excessive drinking, hypomobility, labored breathing, and mild diarrhea

Mortality:

deaths occurred within 48 hr

Clinical signs:

other: No data

Gross pathology:

No data

Other findings:

No data

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category IV

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral lethal dose (LD50) of Dibromoacetic acid in male rat was found to be 1737 mg/kg of body weight. Administration of Dibromoacetic acid to rat by oral gavage route indicates that Dibromoacetic acid is exhibits acute oral toxicity.

Executive summary:

To assess the acute toxicity ofDibromoacetic acid (DBAA), 15 maleSprague-Dawley ratswere treated with 0 (water control), 1000 or 2000 mg DBAA/kg/day by oral administration (gavage) for 14 days.

Signs of toxicity observed in animals treated with Dibromoacetic acid were excessive drinking, hypomobility, labored breathing, and mild diarrhea. Some animals dosed with DBAA exhibited difficulty in moving limbs and mild ataxia. Most deaths occurred within 48 hr.

The acute oral lethal dose (LD50) ofDBAA to ratwas found to be 1737 mg/kg body weight in the study.