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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:

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:

1980

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

Test material information

Constituent 1

Details on test material:

- Physical state: Pale amber colored liquid
- Storage condition of test material: Room temperature in the dark

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 levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Effect levels 2

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.