Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not specified
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
1960

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Not specified
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Specific details on test material used for the study:
Products of Maruzen Pharmaceuticals Company limited

Test animals

Species:
mouse
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
Weight : between 13 and 17 g

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
With the use of stomach canula, the 10% solution was administered orally.
Doses:
4000, 4500, 5000, 5500, 6000, 6500, 7000 mg/kg dose
No. of animals per sex per dose:
6 healthy mice was used for each materials
Control animals:
not specified
Details on study design:
The animals were kept 7 days after administration of the treatment and observed after 168hours for the mortality.
Statistics:
LD50 and confidence limit at 95% were calculated by Lictchfield-Wilcoxon method.

Results and discussion

Preliminary study:
Not specified
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 8 100 mg/kg bw
Based on:
test mat.
95% CL:
>= 7 700 - <= 8 500
Mortality:
For each group given 5000 mg/kg and 6500 mg/kg doses, only onse mouse of eac group died but the rest survived. At above 7000 mg/kg dose animal started dying.
Clinical signs:
Not specified
Body weight:
Not specified
Gross pathology:
Not specified
Other findings:
Not specified

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

The acute oral LD50 of the substance is 8100 mg/kg bw in mice. The test item exhibit extremely low toxicity.