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Administrative data

Description of key information

Oral (acute oral toxicity study), mouse: LD50: 30.3 g/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:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP study with acceptable restrictions (only 2 animals per dose group, limited documentation and no information on purity)
Reference:
Composition 1
Qualifier:
no guideline followed
Principles of method if other than guideline:
Two male mice per dose were treated with 14.7, 21.5, 31.6 and 46.4 mL/kg bw test substance.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Test material information:
Composition 1
Species:
mouse
Strain:
NMRI
Sex:
male
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 46.4 mL/kg bw

Doses:
14.7, 21.5, 31.6 and 46.4 mL/kg bw (equivalent to 14.1, 20.6, 30.3 and 44.5 g/kg bw based on a relative density value of 0.96)
No. of animals per sex per dose:
2
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs
Statistics:
LD50 was determined graphically.
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
31.6 mL/kg bw
Based on:
test mat.
Remarks on result:
other: equivalent to 30.3 g/kg bw based on a relative density of 0.96
Mortality:
No mortality occurred at a dose level of 14.7 and 21.5 mL/kg bw. One animal died at a dose of 31.6 mL/kg bw. Two animals died in the highest dose group (46.4 mL/kg bw).
Clinical signs:
The following clinical signs were seen: sedation, ataxia, dyspnea, mydriasis, tremor, tonic cramps, abdominal position. Death occurred within 24 hours after treatment.
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
In this acute oral toxicity study a LD50 value of 31.6 mL/kg bw (equivalent to 30.3 g/kg bw based on a relative density of 0.96) in male mice was found.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The available information comprises an adequate and reliable study (Klimisch score 2), and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.

Additional information

Justification for selection of acute toxicity – oral endpoint
There is only one study available.

Justification for classification or non-classification

The available data on acute oral toxicity do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.