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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:
10th October 1996 to 13th December 1996
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:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test material: Millad®3988
Lot No.: 5001
Description: White powder

The Sponsor assumes responsibility for purity and stability determination.

Test animals

Species:
rat
Strain:
other: Crl:CD(SD)BR
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Inc., Kingston, New York
- Age at study initiation: Young adult (exact age not specified)
- Weight at study initiation: 216 to 246 g
- Fasting period before study: Approximately 21 to 22 hours before test material administration, food, but not water, was withheld.
- Housing: The animals were separated by sex and group housed in screen-bottom stainless steel cages.
- Diet (e.g. ad libitum): Laboratory Rodent Diet #5001, PMI Feeds, Inc; available ad libitum during the study and acclimation period.
- Water (e.g. ad libitum): Available ad libitum during the study and acclimation period.
- Acclimation period: The animals were acclimated for a period of at least 7 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 °C
- Humidity (%): 50% ± 20%
- Air changes (per hr): Not specified
- Photoperiod: 12 hours light/ 12 hours dark lighting cycle

IN-LIFE DATES: From: 14th October 1996 To: 28th October 1996

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5% w/v Methylcellulose and 1.0% w/v Tween 80
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.25 g test material/mL vehicle
- Amount of vehicle (if gavage): Not specified
- Justification for choice of vehicle: Not specified
- Lot/batch no. (if required): Not specified
- Purity: 0.5% w/v Methylcellulose and 1.0% w/v Tween 80 in distilled water

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw

DOSAGE PREPARATION (if unusual): Not applicable
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 male and 5 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were conducted at approximately 1, 2.5, and 4 hours after test material administration and daily thereafter for 14 days. Mortality checks were conducted twice a day (morning and afternoon) for 13 days after the test material administration and again on the morning of Day 14. Body weights were determined before test material administration (Day 0), at Day 7, and at termination of the experimental phase (Day 14).
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs and body weights were recorded as specified above.
Statistics:
No statistical analyses were required by the protocol.

Results and discussion

Preliminary study:
Not performed
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No mortality was observed during the study. The estimated oral LD50 values for male and female rats were determined to be greater than 5000 mg/kg bw.
Clinical signs:
All animals appeared normal throughout the study.
Body weight:
All animals exhibited body weght gain throughout the study.
Gross pathology:
There were no lesions observed at necropsy.
Other findings:
None reported

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
All animals appeared normal and gained weight during the study. There were no gross lesions observed at the necropsy examinations conducted at termination. The estimated oral LD50 values for male and female rats were determined to be greater than 5000 mg/kg bw.
Executive summary:

The test material, Millad®3988, was evaluated for its acute oral toxicity potential in male and female rats when administered as a single gavage dose at a level of 5000 mg/kg bw. The estimated oral LD50 values for male and female rats were determined to be greater than 5000 mg/kg bw. All animals appeared normal and exhibited body weight gain throughout the study. The gross necropsy examinations at termination revealed no test material related lesions.