Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Remarks:
Intraperitoneal administration
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not specified
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
significant methodological deficiencies

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
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:
intraperitoneal
Vehicle:
not specified
Details on exposure:
Not specified
Doses:
1000 mg/kg dose. Death started to occur after 1100 mg/kg and from that point on, the dose was increased by 100 mg increment. 15 doses up to 2000 mg/kg were observed.
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

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 1 400 mg/kg bw
Based on:
test mat.
95% CL:
>= 1 280 - <= 1 540
Mortality:
Not death observed until 1000 mg/kg dose. Death started to occur after 1100 mg/kg and from that point on, the dose was increased by 100 mg increment. 15 doses up to 2000 mg/kg were observed. Those that died were found dead within 24h All those that survived were found to have survived during the 168 hours period.
Clinical signs:
With the dose at which death was observed, the material caused animals ti graduallly increase their writhing and clonic spasm after several minutes of resting after administration. They develop hyperpnea and started belly-crawling. They became dyspnea and ataxia, and then apnea to die within half an hour. The heart movement did not ceased yet at the moment of death.
Body weight:
Not specified
Gross pathology:
Not specified
Other findings:
Not specified

Applicant's summary and conclusion

Executive summary:

The acute intraperitoneal LD50 of the substance is 1400 mg/kg bw in mice. The test item exhibit low toxicity.