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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:
1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
yes
Remarks:
Research & Consulting Company AG
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: solid
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH 4414 Fuellinsdorf/Switzerland
- Age at study initiation: 9 to 11 weeks
- Weight at study initiation: Males 192 to 210 g, Females 173 to 181 g
- Fasting period before study: 12 to 18 hours
- Housing: Housed in groups of 5 in Makrolon type-3 cages
- Diet (e.g. ad libitum): Pelleted standard Kliba 343
- Water (e.g. ad libitum): Community tap mater
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 40 to 70
- Air changes (per hr): 10 to 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: Jun 5, 1986 To: Jun 26, 1986

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
4% solution in distilled water
Details on oral exposure:
VEHICLE
- Amount of vehicle (if gavage): 20 mL/kg body weight
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Each animal was examined for changes in appearance, behavior four times during test Day 1, and daily during Days 2 to 15, body weight on Days 1, 8, and 15, and mortality/viability 4 times during test Day 1, and daily during Days 2 to 15.
- Necropsy of survivors performed: Yes. Necropsies were performed for all animals.
Statistics:
The toxicity was estimated without use of a statistical model.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Remarks on result:
other: 20% of animals died.
Mortality:
One male and one female rat died on Day 3 of the test period.
Clinical signs:
The symptoms observed were sedation, dyspnea, ataxia (males), curved body position, and ruffled fur, which disappeared within 7 days.
Body weight:
There was increase in the body weight during the observation period. The mean body weight in males was 201, 208 and 246 g at day 1, 8 and 15 of the study, respectively. The mean body weight in females was 179, 188 and 200 g at day 1, 8 and 15 of the study, respectively.
Gross pathology:
In the 2 animals that died on Day 3, the following macroscopic organ changes were observed:
lung: dark-red mottled, not collapsed
intestines/stomach: meteorism severe, yellowish contents
In the animals that were terminated at the end of the test period, the following macroscopic organ changes were observed:
lung: dark-red mottled

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of this study, the oral LD50 in rats is greater than 5000 mg/kg.
Executive summary:

In a GLP compliant OECD guideline study, 5 male and 5 female Wistar rats were treated with the test substance by oral gavage administration. The test item was diluted in 4% carboxymethyl cellulose and applied at a dose level of 5000 mg/kg body weight. All animals were observed for toxicity and mortality four times during test day 1 and once daily thereafter during the post-dose observation period of 14 days. Body weights were recorded on days 1, 8 and 15. All animals were necropsied and examined macroscopically. One male and one female animal died on test day 3. The surviving animals showed symptoms of sedation, dyspnea, ataxia (males), curved body position, and ruffled fur, which disappeared within 7 days. All surviving animals gained weight normally. In the 2 animals that died, the following macroscopic organ changes were observed: dark-red mottled lungs, not collapsed, severe meteorism in intestines/stomach with yellowish content. In the animals that were terminated at the end of the test period, the following macroscopic organ changes were observed: dark red mottled lung. Based on the result of this study, the LD50 was determined to exceed 5000 mg/kg body weight.