Registration Dossier

Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well-documented study, but test substance not clearly identified and background exposure through diet not stated.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Renal damage associated with silicon compounds in dogs.
Author:
Newberne, P. M. and Wilson, R. B.
Year:
1970
Bibliographic source:
Proc. Nat. Aca. Sc. 65(4), 872-875.
Reference Type:
review article or handbook
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
SOURCE: Not reported
PURITY: Not reported
IMPURITY/ADDITIVE/ETC.: Not reported
ANY OTHER INFORMATION: Molar ratio not reported

Test animals

Species:
rat
Strain:
other: Charles River Cesarean-Derived (CD)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ORGANISMS
- Weight at study initiation:  80-100 g

Administration / exposure

Route of administration:
oral: feed
Vehicle:
other: feed
Duration of treatment / exposure:
4 weeks
Frequency of treatment:
daily
Doses / concentrations
Remarks:
Doses / Concentrations:
2400 mg/kg bw/d
Basis:
other: nominal conc.
No. of animals per sex per dose:
15
Control animals:
yes

Examinations

Observations and examinations performed and frequency:
CLINICAL OBSERVATIONS AND FREQUENCY: 
- Clinical signs: registered daily
- Mortality: registered daily
- Body weight: registered weekly
- Food consumption: registered with unknown frequency
- Haematology: Total WBC count, differential WBC count, packed cell volume, prothrombine time and serum hemoglobin was registered weekly. 
- Urinalysis: Urinary specific gravity protein concentration, glucose concentration and urea nitrogen was registered weekly.
Sacrifice and pathology:
ORGANS EXAMINED AT NECROPSY (MACROSCOPIC AND MICROSCOPIC): 
- Macroscopic: the weight of not specified organs was registered.
- Microscopic: A set of tissues was preserved in formalin for histopathological examination. There are no further details.

Results and discussion

Effect levels

Dose descriptor:
NOAEL
Effect level:
2 400 mg/kg bw/day (nominal)
Sex:
male/female
Basis for effect level:
other: polydipsia, polyuria and soft stools

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

TOXIC RESPONSE/EFFECTS BY DOSE LEVEL: 
- Mortality and time to death: None
- Clinical signs: Polydipsia, polyuria and soft stools was observed in a few animals (not quantified)
- Body weight gain: No effects
- Food/water consumption: No effects
- Clinical chemistry: No effects
- Haematology: No effects
- Urinalysis: No effects
- Organ weights: No effects
- Gross pathology: No effects
- Histopathology: No effects

Applicant's summary and conclusion