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Description of key information

Acute Toxicity: Oral:

According to the study, the acute oral median lethal dasage (LD50) calculated by probit analysis, were:

Rats:

- male: 2600 mg/kg

- female: 2700 mg/kg

- combined sexes: 2650 mg/kg

Mice:

- male: 3000 mg/kg

- female: 2900 mg/kg

- combined sexes: 2950 mg/kg

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
2 September - 9 October 1985
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Reference:
Composition 0
Qualifier:
no guideline available
Principles of method if other than guideline:
Initial Screening was carried out in six groups, each of two males and two females rats and mice in order to find the general level of acute toxicity of the test material. After these preliminary observation, test material was administered by gavage of rats in single dose of 1680, 2100, 2630, 3260, 4110 mg per kg body weight and the stomach of mice in single dose of 1400, 1700, 2100, 2600, 3300, 4100, 5200 mg per kg body weight. For each dose five males and five females were used. After treatment, the rats and mice were odserved for signs of intoxication during the first 4 post-treatment hours and thereafter daily throughout a 14 day observation period. Individual body weights were determined on day 0, 7 and 14. At the end of the observation period the survivors were killed and ewamined grossly. The LD50 was calculated according to the method of Litchfield-Wilcoxon.
GLP compliance:
not specified
Test type:
fixed dose procedure
Limit test:
no
Test material information:
Composition 1
Species:
rat
Strain:
Wistar
Remarks:
and mice
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: rats: approximately 35 days old, mice: 49 days old
- Weight at study initiation: 120g to 140g for male rats, 110g to 130g for female rats. 12g to 31g for the mice
- Fasting period before study: on the day of dosing test material
- Housing: polycarbonate cages with stainless steel grid tops
- Diet: complete pelleted rodent diet was fed without restriction
- Water: tap water freely available
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25°C ± 2°C
- Humidity (%): 45 - 75 %
- Air changes: yes
- Photoperiod (hrs dark / hrs light): artificial light with a sequence of 12 hours light and 12 hours dark
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Single dose of the test material

Doses during the preliminary study:
Rats: 500, 1000, 2000, 4000 and 6000 mg/kg
Mice: 200, 500, 1000, 2000, 4000 and 8000 mg/kg
Doses:
Rats: 1680, 2100, 2630, 3260 and 4110 mg/kg bw
Mice: 1400, 1700, 2100, 2600, 3300, 4100 and 5200 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: first 4 post-treatment hours then daily throughout a 14 day observation period
- Necropsy of survivors performed: yes
Preliminary study:
Rats: mortalitily at dose levels of 4000 mg/kg and 6000 mg/kg observed
Mice: mortalitily at dose levels of 4000 mg/kg and 8000 mg/kg observed
Key result
Sex:
male
Dose descriptor:
LD50
Remarks:
Rats
Effect level:
2 600 mg/kg bw
Based on:
test mat.
Key result
Sex:
female
Dose descriptor:
LD50
Remarks:
Rats
Effect level:
2 700 mg/kg bw
Based on:
test mat.
Key result
Sex:
male/female
Dose descriptor:
LD50
Remarks:
Rats
Effect level:
2 650 mg/kg bw
Based on:
test mat.
Key result
Sex:
male
Dose descriptor:
LD50
Remarks:
Mice
Effect level:
3 000 mg/kg bw
Based on:
test mat.
Key result
Sex:
female
Dose descriptor:
LD50
Remarks:
Mice
Effect level:
2 900 mg/kg bw
Based on:
test mat.
Key result
Sex:
male/female
Dose descriptor:
LD50
Remarks:
Mice
Effect level:
2 950 mg/kg bw
Based on:
test mat.
Mortality:
Deaths occured between 6 hours and 2 days after treatment. Then the survivors recovered gradually and looked quite healthy again at the end of the observation period.
Body weight:
No decreasing body weight observed.
Gross pathology:
Macroscopic examination of the survivors at autopsy did not reveal any treatment-related gross alteration.
Other findings:
See attachment for results.
Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
Under the conditions of this study the acute oral median lethal dasage (LD50) calculated by probit analysis, were:
Rats:
- male: 2600 mg/kg
- female: 2700 mg/kg
- combined sexes: 2650 mg/kg
Mice:
- male: 3000 mg/kg
- female: 2900 mg/kg
- combined sexes: 2950 mg/kg
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 650 mg/kg bw

Additional information

Justification for classification or non-classification

According to the Annex I: 3.1.2.1, Table 3.1.1 of the CLP regulation, the test substance is not classified. According to the Chapter 3.1, Table 3.1.1 of the GHS classification, the test item is not classified.