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Description of key information

Based on the study results, the oral LD50 for the test substance in mice was determined to be 22880 mg a.i./kg bw.

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:
key study
Study period:
1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
according to guideline
Guideline:
other: generally accepted scientific principles and well documented study details, acceptable for assessment
Deviations:
not specified
GLP compliance:
no
Limit test:
no
Species:
mouse
Strain:
other: Royalhart
Sex:
female
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
The 75% concentration of the test substance in water was administered orally to female mice. Ten animals per group received doses/20 g mouse of 0.5, 0.6, 0.7 and 1.0 cc and a mortality curve was further calculated based on a 14-day observation period.
Doses:
doses/20 g mouse of 0.5, 0.6, 0.7 and 1.0 cc
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
The LD-50 was evaluated using the Miller-Tainter method.
Preliminary study:
-
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
ca. 22 880 mg/kg bw
Based on:
act. ingr.
Mortality:
Mortality was observed from the dose of 0.6 cc and above.
Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, the LD50 for the test substance in mice was determined to be 0.61 mL. Based on a bodyweight of 20 g and a purity of 75%, this corresponds to 22880 mg a.i./kg bw.
Executive summary:

A study was conducted to determine the acute oral toxicity of the test substance (purity: 75%) according to the Miller-Tainter method. A 75% concentration of the test substance in water was administered orally to female mice. Ten animals (20 g bodyweight) per group received doses of 0.5, 0.6, 0.7 and 1.0 mL and a mortality curve was calculated based on a 14 d observation period. The LD50 was evaluated using the Miller-Tainter method. Mortality was observed from the dose of 0.6 mL and higher. Under the study conditions, the LD50 for the test substance in mice was determined to be 0.61 mL. Based on a bodyweight of 20 g and a purity of 75%, this corresponds to 22880 mg a.i./kg bw (South Mountain Laboratories, 1972).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
22 880 mg/kg bw
Quality of whole database:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

A study was conducted to determine the acute oral toxicity of the test substance (purity: 75%) according to the Miller-Tainter method. A 75% concentration of the test substance in water was administered orally to female mice. Ten animals (20 g bodyweight) per group received doses of 0.5, 0.6, 0.7 and 1.0 mL and a mortality curve was calculated based on a 14 d observation period. The LD50 was evaluated using the Miller-Tainter method. Mortality was observed from the dose of 0.6 mL and higher. Under the study conditions, the LD50 for the test substance in mice was determined to be 0.61 mL. Based on a bodyweight of 20 g and a purity of 75%, this corresponds to 22880 mg a.i./kg bw (South Mountain Laboratories, 1972).

Justification for classification or non-classification

Based on available study results, the test substance does not warrant classification for acute oral toxicity according to EU CLP criteria (Regulation 1272/2008/EC).

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