(2-hydroxyethyl)ammonium nitrate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro cytogenicity / chromosome aberration study in mammalian cells

Remarks:

Type of genotoxicity: chromosome aberration

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The reliability and summary were made based on the HPV program adopted during OECD SIAM 25 (October 2007). Only limited information is available on methods and results; the article is a review article of more than 200 investigated substances.

Data source

Reference

Reference Type:

publication

Title:

Primary mutagenicity screening of food additives currently used in Japan

Author:

Ishidate Jr M, Sofuni T, Yoshikawa K, Hasashi M, Nohmi T, Sawada M and Matsuoka A

Year:

1984

Bibliographic source:

Fd Chem Toxic 22: 623-636

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

no metabolic activation used, cytotoxicity not measured, exposure durations of 24 and 48 hours, 100 metaphases investigated

GLP compliance:

no

Type of assay:

in vitro mammalian chromosome aberration test

Test material

Test material information

Constituent 1

Reference substance name:

Sodium nitrate

EC Number:

231-554-3

EC Name:

Sodium nitrate

Cas Number:

7631-99-4

IUPAC Name:

sodium nitrate

Details on test material:

- Name of test material: Sodium nitrate
- Analytical purity: 99.3 %

Method

Species / strain

Species / strain / cell type:

other: Chinese hamster fibroblast cell line, CHL

Details on mammalian cell type (if applicable):

- Type and identity of media: minimum essential medium (MEM), supplemented by 10 % calf serum
- Other: The cell line was originally established from the lung of a newborn female at the Cancer Research Institute, Tokyo (Koyama, Utakoji and Ono, 1970). The modal chromosome number was 25 and the doubling time was approximately 15 hours.

Reference
- Koyama H, Utakoji T and Ono T (1970). A new cell line derived from newborn Chinese hamster lung tissue. Gann 61: 161-167.

Metabolic activation:

without

Test concentrations with justification for top dose:

5 mg/mL (highest dose tested), maximum dose selected in a preliminary test (not reported), 3 different concentrations (not given)

Vehicle / solvent:

- Vehicle/solvent used: physiological saline

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

not specified

Positive control substance:

not specified

Details on test system and experimental conditions:

DURATION
- Exposure duration: 24 and 48 hours

SPINDLE INHIBITOR
- Colcemid (added 2 hours prior to cell harvesting)

FIXATION
- Cells were fixed with acetic acid-methanol (1:3 v/v)

STAIN
- Giemsa

NUMBER OF CELLS EVALUATED
- 100 well-spread metaphases were observed

Evaluation criteria:

The result was considered to be negative if the incidence of aberrations was less than 4.9 %, equivocal if it was between 5.0 and 9.9 % and positive if it was more than 10 %.

Statistics:

For a quantitative evaluation of the clastogenic potential, the D20 was calculated, which is the dose (mg/mL) at which structural aberrations (including gaps) were detected in 20 % of the metaphases observed.
In addition, the TR value was calculated, which indicates the frequency of cells with exchange-type aberrations per unit dose (mg/mL).

Results and discussion

Test results

Species / strain:

other: Chinese hamster fibroblast cell line, CHL

Metabolic activation:

without

Genotoxicity:

positive

Remarks:

24 % structural aberration at 48 hours

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

other: incidence of aberrations usually less than 3.0 %

Untreated negative controls validity:

other: incidence of aberrations usually less than 3.0 %

Positive controls validity:

not specified

Additional information on results:

D20: 5.73 mg/mL
TR: 0.8
Also positive at 4 mg/mL at both 24 hours (10.0 %) and 48 hours (10.0 %).

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.