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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
chronic toxicity: oral
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Documentation insufficient for assessment (analytical purity of test substance not specified).

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1971

Materials and methods

Principles of method if other than guideline:
Chronic feeding study in rats.
GLP compliance:
no
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): trade name given
- Analytical purity: no data

Test animals

Species:
rat
Strain:
not specified
Sex:
male

Administration / exposure

Route of administration:
oral: feed
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
no data
Duration of treatment / exposure:
2 years
Frequency of treatment:
no data
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
5%
Basis:
nominal in diet
Remarks:
Doses / Concentrations:
5000 mg/kg bw/d
Basis:
other: based on the assumption of an average food uptake of 20 g/animal and an average body weight of 200 g
No. of animals per sex per dose:
no data
Control animals:
not specified
Positive control:
no data

Examinations

Observations and examinations performed and frequency:
DETAILED CLINICAL OBSERVATIONS: Yes

BODY WEIGHT: Yes

HAEMATOLOGY: Yes
Sacrifice and pathology:
GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
Other examinations:
no data
Statistics:
no data

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
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:
no effects observed
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:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Histopathological findings: neoplastic:
not specified
Details on results:
The test material produced no significant effects on growth pattern, survival, blood count, gross pathology, or histological findings in the liver, kidneys, urine, bladder, prostate gland, pituitary gland, salivary gland, adrenal gland, heart, lungs, testicle, muscle and bone marrow.

Effect levels

Dose descriptor:
NOAEL
Effect level:
>= 5 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male
Basis for effect level:
other: based on the assumption of an average food uptake of 20 g/animal and an average body weight of 200 g

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion