Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: other route
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1988
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Review data only.

Data source

Reference
Reference Type:
review article or handbook
Title:
VCVN1* "Vrednie chemichescie veshestva. Neorganicheskie soedinenia elementov I-IV groopp" (Hazardous substances. Inorganic substances containing I-IV group elements)
Author:
Filov V.A.
Year:
1988
Bibliographic source:
Chimia, 1988, page 351

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Public available literature. No guideline indicated. For details on method see materials and methods section.
GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no details given

Test animals

Species:
monkey
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
not indicated.

Administration / exposure

Route of administration:
subcutaneous
Vehicle:
not specified
Details on exposure:
not indicated.
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
60 days
Frequency of treatment:
not indicated.
Doses / concentrations
Remarks:
Doses / Concentrations:
not indicated.
No. of animals per sex per dose:
not indicated.
Control animals:
not specified
Details on study design:
not indicated.

Examinations

Observations and examinations performed and frequency:
not indicated.
Sacrifice and pathology:
not indicated.
Other examinations:
not indicated.
Statistics:
not indicated.

Results and discussion

Results of examinations

Clinical signs:
not specified
Mortality:
not specified
Body weight and weight changes:
not specified
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
effects observed, treatment-related
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
not specified
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified
Details on results:
Spinal Cord - meningeal changes

Effect levels

Key result
Dose descriptor:
other: TDLo - Lowest published toxic dose
Effect level:
1 500 other: mg/kg/60 days
Based on:
test mat.
Sex:
not specified
Basis for effect level:
other: Spinal Cord - meningeal changes equivalent to 25 mg/kg bw/day

Applicant's summary and conclusion

Conclusions:
The TDLo (lowest published toxic dose) = 1500 mg/kg/ 60 days equivalent to 25 mg/kg bw/day (intermittent).
Executive summary:

In a subacute toxicity study sodium cyanate was administered to monkeys subcutaneous for 60 days.

Effects: Spinal Cord - meningeal changes

The TDLo (lowest published toxic dose) = 1500 mg/kg/ 60 days equivalent to 25 mg/kg bw/day (intermittent).

This subacute study in the rat is acceptable, as supporting study.