Benzene, ethenyl-, ar-bromo derivs.

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

3 December 1982 to 13 January 1983

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

Specific details have not been provided

GLP compliance:

no

Remarks:

Not-GLP but QA statement included.

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Benzene, dibromoethyl Benzene, ethenyl-, ar-bromo derivs.

EC Number:

603-094-7

Cas Number:

125904-11-2

Molecular formula:

C8 H6 Br2

IUPAC Name:

Benzene, dibromoethyl Benzene, ethenyl-, ar-bromo derivs.

Test material form:

liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Portage, Michigan, USA
- Age at study initiation: young adult
- Weight at study initiation: 210.1 to 272.5 g
- Fasting period before dosing: 24 hours
- Housing: individually in wire-bottomed cages suspended above the cage board that was changed three times a week
- Diet: Purina Certified Rodent Chow 5002 ad libitum (with the exception of the fasting period; re-offered 1 hour after dosing)
- Water: ad libitum
- Acclimation period: 15 to 43 days

ENVIRONMENTAL CONDITIONS
- Controlled temperature and humidity room
- Photoperiod: 12 hours light a day

IN-LIFE DATES: 3 December 1982 to 13 January 1983

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Dosages were calculated on the basis of test substance specific weight of approx 1.83 g per mL.
Food was re-offered 1 hour after dosing

Doses:

5000, 6250 and 7500 mg/kg bw

No. of animals per sex per dose:

5 per sex per dose

Control animals:

no

Details on study design:

The dose level of 5000 mg/kg was used at first. Additional doses were added to allow LD50 calculation.

Statistics:

LD50 was calculated according to Litchfield and Wilcoxon (1949)

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

5 790 mg/kg bw

95% CL:

4 826 - 6 946

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

6 937 mg/kg bw

95% CL:

5 906 - 8 148

Effect levels 3

Sex:

male/female

Dose descriptor:

LD50

Effect level:

6 327 mg/kg bw

95% CL:

5 622 - 7 121

Mortality:

Deaths occurred on days 1 to 2.
5000 mg/kg bw: 1 male on day 2 (1/5 males; combined: 1/10)
6250 mg/kg bw: 1 male on day 1, 2 males on day 2 (3/5); 2 females on day 2 (2/5) (combined: 5/10)
7500 mg/kg bw: 4 males on day 1, 1 male on day 2 (5/5); 3 females on day 3 (3/5) (combined: 8/10)

Clinical signs:

other: On the day of dosing 5000 mg/kg bw: slight ataxia (all animals at 3 to 5 hours) 6250 mg/kg bw: slight salivation (2M at 2 to 4 hrs), slight to mild lethargy (5M at 4 to 5 hrs), moderate ataxia (5M at 5 hrs), slight to mild urine stains (1M at 5 hrs and 2F

Gross pathology:

Findings ranged from no significant findings (all animals at terminal sacrifice) to stomach distended with food, forestomach with shaggy white or chalky white material present, hindstomach reddened or pale with or without focal haemorrhage, intestines reddened in decent animals from all groups.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

The test substance is practically not toxic by the oral route of exposure, with a LD50 value of 6327 mg/kg bw for both sexes combined.

Executive summary:

In an acute oral toxicity study, groups of 5 male and 5 female Sprague-Dawley rats received single oral doses of the undiluted test substance at 5000, 6250 or 7500 mg/kg bw after a fasting period of 24 hours. Food was re-offered 1 hour after dosing. Deaths occurred on days 1 and 2. A single male rat died in the group treated at 5000 mg/kg bw. A total of 5 animals (3 males and 2 females) died in the group treated at 6250 mg/kg bw. A total of 8 animals (5 males and 3 females) died in the group treated at 7500 mg/kg bw. Signs of toxicity were noted in all treated animals; survivors appeared normal by day 4 (5000 and 6250 mg/kg bw) or day 5 (7500 mg/kg bw). Individual and mean body weights increased at each interval afetr dosing, with the exception of a single female treated at 6250 mg/kg bw on day 13. No significant macroscopic findings were noted at termination for surviving animals, while stomach distended with food, forestomach with shaggy white or chalky white material present, hindstomach reddened or pale with or without focal haemorrhage, intestines reddened were observed in decent animals from all groups.

The LD50 was calculated to be 6327 mg/kg bw for both sexes combined.