Registration Dossier

Administrative data

Description of key information

NOAEL = 58 mg/kg bw

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Data is from ECHA QSAR Toolbox no information about the test type.
Qualifier:
no guideline followed
Principles of method if other than guideline:
no data given
GLP compliance:
not specified
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: feed
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
no data
Frequency of treatment:
no data
Remarks:
Doses / Concentrations:
0 ppm
Basis:
nominal in diet
Remarks:
Doses / Concentrations:
50 ppm
Basis:
nominal in diet
Remarks:
Doses / Concentrations:
200 ppm
Basis:
nominal in diet
Remarks:
Doses / Concentrations:
800 ppm
Basis:
nominal in diet
No. of animals per sex per dose:
no data
Control animals:
yes
Observations and examinations performed and frequency:
no data
Sacrifice and pathology:
no data
Other examinations:
no data
Statistics:
no data
Clinical signs:
not specified
Mortality:
not specified
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
LOEL lowest observed effect level: 10 mg/kg/day
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):
not specified
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
Dose descriptor:
NOEL
Effect level:
ca. 3 other: mg/kg/day
Based on:
test mat.
Sex:
not specified
Basis for effect level:
other: Effect: body weight changes
Critical effects observed:
not specified
Conclusions:
The NOEL is 3 mg/kg/day ( repeated dose toxicity rat)
Executive summary:

The NOEL is 3 mg/kg/day ( repeated dose toxicity rat)

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
58 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Quality of whole database:
reliable 2

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

NOAEL: 58 mg/kg bw


Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
read-accross with cycloate

Repeated dose toxicity: via oral route - systemic effects (target organ) digestive: liver

Justification for classification or non-classification