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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP, guideline study available as unpublished report, no restrictions, fully adequate for assessment. NOTE data cannot be used for classification.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
other: Acute limit test
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): MRD-91-935
- Physical state: pale yellow liquid
- Analytical purity: assumed 100%
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
other: Crl:CDBr (Sprague Dawley)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Kingston Facility, Stone Ridge, New York, USA.
- Age at study initiation: Males approx 8 weeks , females approx 10 weeks
- Weight at study initiation: Males 196.14-210.00 g, females 202.82-213.89 g
- Housing: individually
- Diet: Purina Certified Rodent Chow ad libitum (except overnight prior to dosing).
- Water: Mains water ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature: 68-76°F
- Humidity: 40-70%
- Air changes (per hr): Not reported
- Photoperiod: 12hrs dark / 12hrs light

IN-LIFE DATES: From: 8 July 1991 To: 22 July 1991

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
DOSE VOLUME: 7.4305 mL/kg
Doses:
5000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Examined for viability twice daily weekdays and once per day at weekends. Bodyweights recorded prior to dosing, at time of dosing (day 0) and on days 7 and 14.
- Necropsy of survivors performed: yes
Statistics:
Means and SDs of bodyweights were calculated.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
< 5 000 mg/kg bw
Remarks on result:
other: 3/5 males and 4/5 females died following a limit dose of 5000 mg/kg.
Mortality:
Three males and three females found dead on day 0 and a further female found dead on day 2.
Clinical signs:
Majority of abnormal clinical signs were seen in first 6 hours after dosing and included hypoactivity, hypothermia, red anal discharge, wet/dry rales and various ocular and oral discharges. The two surviving males displayed no abnormalities from day 3 onwards. The surviving female had rales, decreased food consumption, small amount of stool and emaciation sporadically until termination.
Body weight:
Two surviving males increased in bodyweight but the surviving female lost weight over the study.
Gross pathology:
In decedents, abnormal contents, vascularisation and reddened mucosa of the stomach and small and large intestines, plus staining of the fur was present. No abnormalities were seen in the two surviving males. The following were seen in the surviving female: a hole in the diaphragm, emaciation, uterine distension and alopecia.

Applicant's summary and conclusion

Interpretation of results:
other: unable to classify, dose used higher than LD 50
Conclusions:
The acute oral LD50 to male and female was less than 5000 mg/kg bodyweight.
Executive summary:

The acute oral LD50 to male and female was less than 5000 mg/kg bodyweight.