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EC number: - | CAS number: -
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Acute Toxicity: oral
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29 April 1980 - 13 May 1980
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Protocol complies with scientifically accepted methods, and is sufficiently detailed.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: CFR, 40, 772. 112-21 (Proposed 7/26/1979).
- Deviations:
- yes
- Remarks:
- Observations were not condiucted at 12 hour intervals, but were conducted twice daily (morning and afternoon) for mortality and once daily for pharmacotoci signs. Body weights were taken at 7 and 14 days instead of the proposed 3~4 day intervals.
- Principles of method if other than guideline:
- Not applicable.
- GLP compliance:
- no
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Details on test material:
- - Physical state: Pale amber colored liquid
- Storage condition of test material: Room temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
-Source: Harlan Sprague-Dawley, Madison, Wisconsin, USA.
-Age at study initiation: approx. 7 weeks of age
-Weight at study initiation: average weight for male was 230 g; average weight for female was 210 g. rates, weight range for male and female was between 205~246 g.
-Fasting period before study: Feed was withheld overnight prior to dosing.
-Housing: housed in groups of 5 by sex.
-Diet: No data.
-Water: available ad libitum.
-Acclimation period: at least 7 days under laboratory conditions.
ENVIRONMENTAL CONDITIONS
-Temperature (°C): controlled environment, but no temperature provided.
-Humidity (%):controlled environment, but no humidity information provided.
-Air changes: controlled environment, but no air change information provided.
-Photoperiod: controlled environment, but no photoperiod information provided.
IN-LIFE DATES: From: 04/22/1980 To: 05/13/1980.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: Not applicable.
- Amount of vehicle (if gavage): Not applicable.
- Justification for choice of vehicle: Not applicable.
- Lot/batch no. (if required): Not applicable.
- Purity: Not applicable.
MAXIMUM DOSE VOLUME APPLIED: 4.35 ml/Kg.
DOSAGE PREPARATION (if unusual): Not applicable.
CLASS METHOD (if applicable): Not applicable.
- Rationale for the selection of the starting dose: No data. - Doses:
- 500 mg/kg bw
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: each animals was observed for pharmacotoxic signs and mortality at 1, 2.5, and 4 hours after compound administration. Fro 14 days thereafter the animals were observed daily for pharmacotoxic signs and twice daily for mortality. All animals were weighed just before compound administration. Body weight of all surviving animals was taken again at 7 and 14 days after administration of the test material.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- no data
Results and discussion
- Preliminary study:
- Not available.
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- Male: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- other: No deaths occurred and no clinical signs of toxicity or behavioral changes were reported.
- Gross pathology:
- Not visible lesions observed, except one female rat showed mild hydrometra in uterus.
- Other findings:
- - Organ weights: No data available.
- Histopathology: No data available.
- Potential target organs: No data available.
- Other observations: No data available.
Any other information on results incl. tables
Table 1. Results
|
Male |
Female |
|
Dose Level (mg/kg) |
5000 |
5000 |
|
Average Body Weight (g) |
Initial |
230 |
210 |
7 days |
291 |
233 |
|
14 days |
323 |
232 |
|
Mortality (No. death/No. dosed) |
0/5 |
0/5 |
|
Visible lesions |
0/5 |
1/5 showed mild hydrometra in uterus. |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: other: GHS
- Conclusions:
- The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley strain Albino rats was found to be greater than 5000 mg/kg bodyweight. The test substance was classified as non-toxic.
- Executive summary:
In an acute oral toxicity study, 2 groups fasted 7 week old Sprague-Dawley strain Albino rats (five male and five female) were given a single oral dose of undiluted test material at a dose level of 5000 mg/kg bw and observed for14 days. No mortality occurred. No signs of systemic toxicity, or behavioral changes were reported during the study, and no abnormalities were noted at necropsy, except one female rat showed mild hydrometra in uterus. All animals showed expected bodyweight gain during the study except female group during day 7 to day 14 period. The oral LD50 value of test material in rats of both sexes was stimulated to exceed 5000 mg/kg bw.
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