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Description of key information

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:
1999-11-02 to 1999-12-14
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD guideline and GLP conform well documented scientific study report.
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
other: Sesame oil
Doses:
single dose: 2000 mg/kg bw (as a 20 % solution in Sesame oil)
No. of animals per sex per dose:
5/sex/dose
Control animals:
no
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred during the whole study period.
Clinical signs:
The following clinical signs were observed after the administration of Hostacor 4323: hypoactivity, squatting posture and bristling coat. Additionally, diarrhea was observed. From day 4 on until the end of the study no findings were observed.
Body weight:
Development of body weight was not impaired
Gross pathology:
No macroscopically changes visible.
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results obtained in this study the median lethal dose value (LD50) of Hostacor 4323 for male and female rats is greater than 2000 mg/kg body weight.
Executive summary:

Acute oral toxicity testing of Hostacor 4323 in the rat yielded a median lethal dose (LD50) above 2000 mg/kg body weight in both male and female animals. After administration of a single dose of the test substance at 2000 mg/kg body weight in sesame oil as vehicle no mortality occurred. The animals showed hypoactivity, squatting posture and bristling coat. Additionally, diarrhea was observed. At day 4 of the study all clinical signs were reversible. Development of body weight was not impaired. All animals were killed at the end of the observation period. No macroscopically visible changes were observed.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
To assess the acute oral toxicity a valid GLP compliant study is available which was performed in accordance to OECD 401.

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

Based on the results obtained in this acute oral toxicity study the median lethal dose value (LD50) of Hostacor 4323 for male and female rats is greater than 2000 mg/kg body weight.

Justification for classification or non-classification

Based on the available data no classification is warranted according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).

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