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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Short post-observation period (7 days), but meets generally accepted scientific standards; sufficiently documented and acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The undiluted compound was fed by stomach tube to male and female Sprague-Dawley rats in increasing doses at increments of fractional (various) log intervals. Observations were made for toxic signs during a 7-day period after dosing and the viscera of the test animals were examined macroscopically.
GLP compliance:
no
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Name of test material (as cited in study report): Mondur PF; no further data given

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 210-330 (males); 225-300 (females)
- Fasting period before study: no data
- Housing: individual
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2000, 3160, 5010, 7940, 12600, 15800 mg/kg bw
No. of animals per sex per dose:
2000 mg/kg: 1 female
3160 mg/kg: 1 male
5010 mg/kg: 1 female
7940 mg/kg: 1 male
12600 mg/kg: 1 female
15800 mg/kg: 2 males, 3 females
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs
Statistics:
no data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 15 800 mg/kg bw
Mortality:
All animals survived the treatment with doses up to and including 15800 mg/kg bw.
Clinical signs:
Toxic signs included reduced appetite and activity for one day.
Body weight:
no data
Gross pathology:
Surviving animals were sacrificed 7 days after dosing. The viscera appeared normal by macroscopic examination.
Other findings:
no data

Applicant's summary and conclusion

Executive summary:

The acute oral toxicity of Mondur PF was low with an LD50 value >15800 mg/kg bw for male and female rats. Single administration of 15800 mg/kg bw was tolerated without mortality, but transient signs of reduced activity were observed.