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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:
1978
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Protocol that complies with scientifically accepted methods, and is sufficiently detailed.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Section 1500.3 – Federal Hazardous Substance and Article, Administration and Enforcement Regulation, Federal Register, Vol. 38, No. 187, p. 27014, 27 September 1973, Section (c) (2) (i).
Deviations:
no
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Sherman-Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
Source: No data available.
Age at study initiation: No data available.
Weight at study initiation: average weight between 200~300 g.
Fasting period before study: Feed was withheld overnight prior to dosing.
Housing: No data available.
Diet: ad libitum
Water: ad libitum
Acclimation period: No data available.

ENVIRONMENTAL CONDITIONS
Temperature (°C): No data available.
Humidity (%):No data available.
Air changes: No data available.
Photoperiod: No data available.

IN-LIFE DATES: From 06/06/1978 To 6/20/1978.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
1,000, 2,000, 4,000, 8,000, and 16,000 mg/kg bw
No. of animals per sex per dose:
5/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data available.
- Necropsy of survivors performed: gross necropsies were performed.

Results and discussion

Preliminary study:
not applicable
Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 3 200 mg/kg bw
Based on:
test mat.
95% CL:
>= 2 000 - <= 5 300
Mortality:
1000 mg/kg/bw:
Number of animals= 5; number of deaths: 0

2000 mg/kg/bw:
Number of animals= 5; number of deaths 2

4000 mg/kg/bw:
Number of animals = 5; number of deaths 2

8,000 mg/kg/bw:
Number of animals = 5; number of deaths 5

16,000 mg/kg/bw:
Number of animals = 5; number of deaths 5

Clinical signs:
All animals died in the high dose group.
In the low dose group, all animals appeared ruffled up to 24 h after treatment, but appeared normal thereafter.
In the low dose group, 1/5 female died on day 6; 2/5 females exhibited diarrhea, and 1/5 exhibited diarrhea and a hunched back.
Body weight:
All animals showed bodyweight gain.
Gross pathology:
No gross abnormalities were noted in all animals (either found dead during the study or in the animals necropsied at the conclusion of the study).

Any other information on results incl. tables

Table 1. Results

Dose

(mg/kg)

Body weight

Mortality

(dead/total No.)

Observation

Initial

Final

1,000

260

290

0/5

2 h: lethargic and depressed

24 h: normal

2,000

250

270

2/5

 

30’: depressed

1 h: quite lethargic

3~4 h: semi-comatose

12~18 h: death occurred.

7 d: normal.

4,000

250

275

2/5

8,000

260

-

5/5

3 h: comatose

< 12 h: death occurred.

16, 000

250

-

5/5

Gross pathologic examination revealed nothing remarkable.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The test article, when administered as received to male Sherman-Wistar rats, had an acute oral LD50 of 3,200 mg/kg bodyweight with 95% confidence limit of from 2,000 to 5,300 mg/kg bodyweight.
Executive summary:

A single dose of the undiluted test material was administered intragastrically to 5 groups of fasted male albino rats (Sherman-Wistar strain) at each treatment level (1,000, 2,000, 4,000, 8,000, and 16,000 mg/kg bw). The animals were observed for signs of toxicity or behavioral changes during the 14 day observation period. Individual weights were recorded on the day of dosing and at termination. All animals died in the 8,000 mg/kg (~ 48 h after treatment) and 16,000 mg/kg (~ 24 h after treatment) dose groups. No mortality in the remaining groups.Gross autopsies were performed and nothing remarkable was revealed.

The oral LD50 value of test material in rats has been determined to be 3,200 mg/kg bodyweight with 95% confidence limit of from 2,000 to 5,300 mg/kg bodyweight.