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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
short-term repeated dose toxicity: other route
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

Reference
Reference Type:
other:
Title:
Nitrate WHO Food Additives Series
Author:
World Health Organization (WHO)
Year:
1996
Bibliographic source:
World Health Organization (WHO)

Materials and methods

Test guideline
Qualifier:
no guideline followed
GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium nitrate
EC Number:
231-554-3
EC Name:
Sodium nitrate
Cas Number:
7631-99-4
Molecular formula:
HNO3.Na
IUPAC Name:
sodium nitrate
Test material form:
solid: crystalline
Details on test material:
- Physical appearance: not indicated
- Purity: not indicated
- Batch No.: not indicated
- Supplier: not indicated

Test animals

Species:
mouse
Strain:
C57BL
Sex:
male

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
15 days
Frequency of treatment:
daily
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 50 and 100 mg/kg bw/day
No. of animals per sex per dose:
not indicated
Control animals:
yes

Results and discussion

Effect levels

Dose descriptor:
other: Cytogenetic and pathohistological changes of the spleen, liver and kidneys
Sex:
male
Remarks on result:
other:
Remarks:
Effect levels not determined

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

A moderate increase in the number of macrophages was observed in the spleen of treated animals. The kidneys showed alterations such as damaged small canals in the cortical part reflected by dystrophic cells, cytoplasm filled with small grains and missing or limited nuclei. In the liver, cell effects analogous to the ones in the kidneys were observed. These effects were reversible.

Applicant's summary and conclusion