Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Limited documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1955
Report Date:
1955

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Company Guideline
Principles of method if other than guideline:
pre-guideline study. According to company guideline.
GLP compliance:
no
Remarks:
previous to GLP implementation

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Sex:
not specified

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
1 g/kg bw/day was administered to 5 rats 7 times within 9 days followed by a two day recovery period.
Doses / concentrations
Remarks:
Doses / Concentrations:
1 g/kg bw/day
Basis:
actual ingested
No. of animals per sex per dose:
5 animals

Examinations

Observations and examinations performed and frequency:
HAEMATOLOGY: Yes, at the beginning and the end of the study
URINALYSIS: Yes, at the beginning and the end of the study
Sacrifice and pathology:
GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes

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:
effects observed, treatment-related
Clinical biochemistry findings:
not specified
Urinalysis findings:
no effects observed
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:
HAEMATOLOGY: 37 % decrease of erythrocytes and 26 % decrease of hemoglobin, formation of methemoglobin
No macroscopic and microscopic findings at necropsy.

Effect levels

Dose descriptor:
NOAEL
Remarks:
(limit test, effects were observed at the single dose tested)
Effect level:
>= 1 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
not specified
Remarks on result:
not determinable
Remarks:
no NOAEL identified

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion