Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
other information
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
Year:
1958
Report Date:
1958

Materials and methods

Principles of method if other than guideline:
Up to 5010 mg/kg of the substance in an aqueous solution of max 10%, has been administered intraperitoneal in mice.
GLP compliance:
no
Remarks:
pre-GLP
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals

Species:
mouse

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
water
Remarks:
distilled
Details on exposure:
1-10% aqueous solution.
Doses:
20, 79, 316, 1260 and 5010 mg/kg
No. of animals per sex per dose:
5010 mg/kg-10 animals, lower doses-2 animals
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: after 1 hour, 24 hours, 48 hours, 3 days and 7 days
- Necropsy of survivors performed: yes on 5 animals
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Results and discussion

Effect levels
Key result
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No mortality was observed.
Clinical signs:
Animals dosed up to 1260 mg/kg did not show any specific signs, animals dosed with 5010 mg/kg showed after 5 hours accelerated breathing, after 8 hours besides accelerated breathing also sticky skin. The next morning only the sticky skin remained.
Body weight:
regular
Gross pathology:
regular

Applicant's summary and conclusion

Conclusions:
LD50 > 51010 mg/kg