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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: Non-guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:
- Age at study initiation: 62-68 days (male); 81-87 days (female)
- Weight at study initiation: 251-317 g (male); 214-249 g (female)
- Fasting period before study: overnight
- Housing: Housed individually in wire bottom cages
- Diet (e.g. ad libitum): ad libitum except overnight prior to dosing
- Water (e.g. ad libitum): ad libitum except overnight prior to dosing
- Acclimation period: 16-22 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50-77
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):


IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
0, 5000 mg/kg
0, 1800, 2700, 4000, 6000 mg/kg
No. of animals per sex per dose:
5 male and 5 female
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 7 and 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology including: nasal passages, trachea, bronchi, heart, lungs, liver, kidneys, adrenal glnds, spleen, gonads, gastrointestinal tract, bladder, body fat and skin.

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
3 400 mg/kg bw
95% CL:
2.2 - 5 200
Sex:
female
Dose descriptor:
LD50
Effect level:
2 900 mg/kg bw
95% CL:
1 900 - 4 700
Mortality:
Male:
0 mg/kg: 0/5
5000 mg/kg: 4/5 rats died 1-3 days after exposure
0 mg/kg: 0/5
1800 mg/kg: 0/5
2700 mg/kg: 0/5
4000 mg/kg: 3/5 rats died 2-6 days after exposure
6000 mg/kg: 5/5 rats died 1-3 days after exposure
Clinical signs:
Clinical signs of toxicity included diarrhea, depression, reduced food consumption, weakness, salivation, blood in the urine and death.
Body weight:
Body weight decreased in 2700 mg/kg and above dose groups compared to control
Gross pathology:
No gross pathological changes observed attributed to the test material.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Remarks:
Migrated information
Conclusions:
The acute oral LD50 for male rats was 3400 mg/kg and 2900 mg/kg for female rats.
Executive summary:

ACUTE ORAL TOXICITY: SINGLE DOSES RANGING FROM 1.8 G/KG TO 6.0 G/KG OF THE UNDILUTED TEST MATERIAL WERE ADMINISTERED INTRAGASTRICALLY TO FIVE FASTED RATS OF EACH SEX. MORTALITY OCCURRED IN MALES DOSED WITH 4.0 G/KG AND GREATER AND IN FEMALES DOSED WITH 2.7 G/KG AND GREATER. SIGNS OF TOXICITY OBSERVED DURING THE STUDY WERE DIARRHEA, DEPRESSION, REDUCED FOOD CONSUMPTION, WEAKNESS, SALIVATION, BLOOD IN URINE, AND DEATH. THE BODY WEIGHTS OF THE TREATED MALES AT THE 2.7 G/KG DOSE LEVEL WERE SIGNIFICANTLY LESS THAN CONTROLS AT SEVEN DAYS. AT AUTOPSY, NO GROSS PATHOLOGICAL CHANGES WERE OBSERVED THAT COULD BE ATTRIBUTED TO THE TEST MATERIAL. THE LD50 (95% CONFIDENCE LIMITS) FOR MALE RATS WAS 3.4 (2.2-5.2) G/KG AND 2.9(1.9-4.7) G/KG FOR FEMALES.