Calcium (S)-2-hydroxypropionate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

publication

Title:

Primary Mutagenicity Screening of Food Additives Currently Used in Japan

Author:

Ishidate M.et al.

Year:

1984

Bibliographic source:

Food Chem. Toxicol. Vol. 22 (8), 623-636

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Calcium chloride

EC Number:

233-140-8

EC Name:

Calcium chloride

Cas Number:

10043-52-4

Molecular formula:

CaCl2

IUPAC Name:

calcium dichloride

Specific details on test material used for the study:

- Name of the test material used in the study: Calcium chloride
- Source: Supplied from the Japan Food Additives Association, Tokyo at the request of the Ministry of Health and Welfare of Japan
- Purity: 74.5%

Method

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA92, TA1535, TA100, TA1537, TA94, TA98

Metabolic activation:

with and without

Metabolic activation system:

- type: rat liver homogenate S9
- method of preparation of S9 mix: the liver microsome fraction S9 was prepared from the liver of Fischer rats pretreated 5 days before with polychlorinated biphenyls.

Test concentrations with justification for top dose:

5.0 mg/plate (highest non cytotoxic dose used in the experiment), in total six concentrations

Vehicle / solvent:

Vehicle(s)/solvent(s) used: phoshate buffer

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

no

True negative controls:

no

Positive controls:

no

Positive control substance:

not specified

Details on test system and experimental conditions:

NUMBER OF REPLICATIONS:
- Number of cultures per concentration (single, duplicate, triplicate): duplicates

TREATMENT AND HARVEST SCHEDULE:
- Preincubation period, if applicable: 20 min at 37 °C before plating
- Exposure duration/duration of treatment: 48 hours

Evaluation criteria:

The result was considered positive if the number of colonies found was twice the number in the control.

Results and discussion

Test results

Key result

Species / strain:

S. typhimurium, other: TA 92, TA 1535, TA 100, TA 1537, TA 94, TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

not examined

Untreated negative controls validity:

valid

True negative controls validity:

not examined

Positive controls validity:

not examined

Applicant's summary and conclusion

Conclusions:

Under the experimental conditions reported, calcium chloride did not cause gene mutations. Therefore, the test item is considered to be non-mutagenic in the bacterial reverse gene mutation assay.

Executive summary:

In a reverse gene mutation assay in bacteria, strains TA92, TA1535, TA100, TA1537, TA94 and TA98 of S. typhimurium were exposed to 242 food additives including calcium chloride. S. typhimurium strains were exposed to calcium chloride at six concentrations (5 mg/plate maximum non-cytotoxic dose) in the presence and absence of mammalian metabolic activation. There was no evidence of induced mutant colonies with and without metabolic activation. Therefore, the test item is considered to be non-mutagenic in this bacterial reverse gene mutation assay.