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Toxicological information

Acute Toxicity: oral

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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

Constituent 1
Chemical structure
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 levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
5 790 mg/kg bw
95% CL:
4 826 - 6 946
Sex:
female
Dose descriptor:
LD50
Effect level:
6 937 mg/kg bw
95% CL:
5 906 - 8 148
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:
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 at 2 to 5 hrs), slight lethargy and ataxia (1F at 5 hrs)
7500 mg/kg bw: slight to moderate ataxia, lethargy and inactivity (all animals at 2 to 5 hrs), urine stains (1M at 3 to 4 hrs), dilated pupils, prostration (1F at 5 hrs), slight lacrimation (1F at 4 to 5 hrs).
Following days
5000 mg/kg bw: slight inactivity, lethargy and ataxia (all animals, days 1 to 3), no faeces (all animals day 1). 1M dead on day 2.
6250 mg/kg bw: anorexia (all animals, day 1), adipsia (2M and 2F, day1); severe lethargy, ataxia, inactivity, prostrate, slowed and laboured respiration, pale extremities and finally death on day 2 (2M and 1 F); urine stains, decreased defecation and lacrimation were also noted in some of these animals. One F showing the above signs recovered to appear normal by day 4. Several animals appeared slightly less affected with signs of mild to slight inactivity or lethargy, lacrimation, decreased faeces or red material around the mouth. 1M and 1F were found dead on day 2 and 2M and 2F appeared normal by day 4. 1F appeared normal on days 4 to 9, showed moderate salivation (day 10 only) and red material around the nose on days 10 and 11, and was normal by day 12.
7500 mg/kg bw: 4M dead on day 1; severe inactivity,prostration, lacrimation, decreased defecation and finally death (1M and 3F day 2). Severe lethargy and ataxia and body cold to touch was present in some of these animals. 2F recovered and appeared normal by day 5.
Body weight:
Individual and mean body weights increased at each interval after dosing, except for one female treated at 6250 mg/kg bw on day 13.
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.