Bromoacetic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1993

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

publication

Title:

Acute Spermatogenic Effects of Bromoacetic Acids

Author:

Linder RE, Klinfelter GR, Strader LF, Suarez JD, Deyer CJ

Year:

1994

Bibliographic source:

Fund. Appl. Toxicol. 22, 422-430

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

The study is performed only with male rats. The results are in line with the newer fixed dose method

GLP compliance:

not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Mono bromo aceti acid

IUPAC Name:

Mono bromo aceti acid

Test material form:

solid: crystalline

Details on test material:

- Name of test material (as cited in study report): mono bromo acetic acid
- Physical state: solid
- Analytical purity: 99%
- origin: Aldrich Chemical company, Milwaukee USA

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Inc. Indianapolis
- Age at study initiation: 3.5 to 4 months
- Weight at study initiation: 413-477 g
- Fasting period before study:
- Housing: 2 animals per cage

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 1 deg. C
- Humidity (%): 50 +- 10% relative humidity
- Photoperiod (hrs dark / hrs light): 12 h

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

distilled water adjusted with NaOH to pH 6.5

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 5 ml
- Justification for choice of vehicle: soluble in water
- Purity: distilled water

MAXIMUM DOSE VOLUME APPLIED: 5 ml

Doses:

100 to 200 mg/kg bw

No. of animals per sex per dose:

5 male animals per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 to 21 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, epididymal sperm morphology and histopathology of the testis and epididymes were performed in addition
For the sperm analysis aditional groups were used: groups of 8 rats received water or MBAA 100 mg/kg and were killed 2 or 14 days after dosing.

Statistics:

LD50 was determined by Probit analysis PROC, Probit.

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

ca. 177 mg/kg bw

Based on:

test mat.

95% CL:

156 - 226

Mortality:

no single data are given

Clinical signs:

increased drinking water consumption, decreased mobility, laboured breathing and diarrhoea were reported. Most deaths occurred within 48 hours after dosing.

Body weight:

no data given

Gross pathology:

no findings

Other findings:

Examination of epididymal sperm and histopathology of the testis did not reveal any test substance related effects in the surviving rats given single doses of MBAA of 100 to 200 mg/kg bw. No changes in rproductive parameters were observed in the satellite group receiving 100 mg/kg bw neither after 2 nor after 14d following a single exposure.

A follow up study with repeated doses of 25 mg MBAA/kg bw was reported not to have revealed any changes in reproductive organs which included testis and epididymes, prostate and seminal vesicles weight, serum testosteron levels, testicular sprem head counts, and epididymal sperm counts.

Applicant's summary and conclusion

Interpretation of results:

toxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral toxicity in male rats was reported to be 177 mg/kg bw with a 95% confidence limit of 156-226 mg/kg bw. Additional invetigations on sperm and testicular toxicity after acute and repeated dosing did not reveal any substance related effects on the investigated repoductive parameters.

Executive summary:

The acute oral toxicity in male rats was reported to be 177 mg/kg bw with a 95% confidence limit of 156-226 mg/kg bw.