Registration Dossier

Administrative data

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)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
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

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male

Administration / exposure

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.

Results and discussion

Effect levels
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.

Applicant's summary and conclusion

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.