Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
January 1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
solid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Test substance
- Age at study initiation: no data
- Weight at study initiation: m: 125 - 135g; f: 110 - 125g
- Fasting period before study: over night
- Housing: single caging, cage type: Macrolon type IlI./max. 5
- Diet: ad libitum; rat diet (R 4 Alleindiät für Ratten), Ssniff Spezialdiäten GmbH, 4770 Soest/Westfalen
- Water: ad libitum
- Acclimation period: 11 d

Environment conditions
- Temperature (°C): 20 - 23
- Humidity (%): 40 - 70
- Air changes (per hr): 10 per h
- Photoperiod (h dark / h light): 12 h daily

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Vehicle
- Concentration in vehicle: 500 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
The test substance was weighed out in a glass, then was filled with Aqua destillata up to the desired volume, was shaken well and afterwards labeled. The formulated test substance was a clear solution.
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
The group of 5 female and 5 male rats were were given a single oral dose 5000 mg/kg of the test substance by gavage.

- Duration of observation period following administration: 14 d
- Body weights were recorded before treatment (Day 1), at the treatment day (Day 0), and on Days 7 and 14 after treatment
- Clinical observation: Animals were observed 1/4 h, 1/2 h, 1 h, 2 h, 4 h after dosing and thereafter once daily up to day 14.
- Necropsy of the survivors performed: yes
Statistics:
As none of the test animals died a calculation of the LD50 was not possible.

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: mortality 0/10
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 350 mg/kg bw
Based on:
act. ingr.
Remarks on result:
other: mortality 0/10
Mortality:
There were no mortalities.
Clinical signs:
Except of ruffled fur on the day of treatment, the animals were free of clinical-/toxicological symptoms during the entire observation period of 14 d.
Body weight:
Body weight changes during the observation period showed a normal weight gain.
Gross pathology:
Necropsies were performed on all animals at the end of the 14 d observation period. In one animal a slight thickening of the stomach mucosa could be observed. Necropsies of all other animals showed no test compound related macroscopic findings in the cranial, thoracic and abdominal cavity.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified based on EU CLP criteria
Conclusions:
Under the study conditions, the oral LD50 value of the test substance was determined to be >5000 mg/kg bw (i.e., equivalent to > 2350 mg a.i./kg bw).

Executive summary:

A study was conducted to determine the acute oral toxicity of the test substance, 'C11-unsatd. AAP TMA-MS (active: 47%)' according to a method similar to OECD Guideline 401. In the study, 5 male and 5 female Sprague-Dawley rats were given a single dose of the test substance at a dose of 5000 mg/kg bw (limit test). The test substance was formulated in water and applied in a volume of 10 mL/kg bw. Animals were subsequently observed for 14 consecutive days. There were no deaths following a single oral dose of the test substance. Except of ruffled fur on the day of treatment, the animals were free of clinical/ toxicological signs during the entire observation period of 14 d. Necropsies were performed on all animals at the end of the 14 d observation period. In one animal a slight thickening of the stomach mucosa could be observed. Necropsies of all other animals showed no test compound related macroscopic findings in the cranial, thoracic and abdominal cavity. Under the study conditions, the oral LD50 value of the test substance was determined to be >5000 mg/kg bw (i.e., equivalent to > 2350 mg a.i./kg bw) (Meisel, 1983).