Jojoboa Oil

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro cytogenicity / micronucleus study

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)

GLP compliance:

yes (incl. QA statement)

Type of assay:

other: in vitro mammalian chromosome aberration test (migrated information)

Test material

Test material information

Constituent 1

Reference substance name:

no defined IUPAC name

EC Number:

612-381-6

Cas Number:

61789-91-1

Molecular formula:

no molecular structure defined

IUPAC Name:

no defined IUPAC name

Test material form:

semi-solid (amorphous): gel

Details on test material:

Components Floraesters 30
Wax Ester ---
36:2 <2
38:0 <1
38:1 2 - 4
38:2 2 - 4
40:0 2 - 4
40:1 14 - 18
40:2 17 - 21
42:0 2 - 4
42:1 14 - 18
42:2 17 - 21
44:0 <2
44:1 4 - 7
44:2 4 - 7
46:2 <3
Iodine Value** 57 - 61
Mono-ester content*** 40 - 47

Method

Species / strain

Species / strain / cell type:

Chinese hamster Ovary (CHO)

Results and discussion

Test results

Key result

Species / strain:

Chinese hamster Ovary (CHO)

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

slight increase in reactivity

Applicant's summary and conclusion

Conclusions:

The test article extracts showed no significant increase of aberrations when compared to the negative
controls. The test article is not considered to be genotoxic when exposed to CHO cells.

Executive summary:

The test was performed to screen the manufacturer's devices and materials to determine if they cause structural chromosome aberrations in industry standard Chinese Hamster Ovary (CHO) cells.

The test was performed in the presence and absence of S9 metabolic activation. The devices were extracted at 50 ± 2°C for 72 ± 2 hours in a polar and alternate solvent. The polar solvent used was

Physiological Saline (Saline). The alternate solvent used was Dimethyl sulfoxide (DMSO). The extracts were placed on cells with and without metabolic activation. Positive and negative controls were run

concurrently with devices. After the expression period, the cells were arrested in metaphase with colcemid. The cells were then harvested and dropped onto microscope slides. The chromosomes were

stained with Giemsa stain and the chromosomes were examined for presence of aberrations. The positive control and the test articles were compared to the negative controls.

The results were evaluated with the chi-square calculation using a validated spreadsheet. The positive control and test article results were compared to the negative control using the chi-square test. The

critical value for the chi-square test is 3.841 at a confidence level of 95%. Any result higher than this value was considered statistically significant. At this point, the biological relevance data was examined to

assess the potential genotoxicity of the test article or positive control.

The non-activated DMSO cytotoxicity data showed a slight increase in reactivity to the test article solutions when placed on CHO cells in comparison to the non-activated DMSO negative control. The

saline and activated DMSO cytotoxicity data showed no increase in reactivity to the test article solutions in comparison to the relative negative controls. The polyploid, endoreduplication rate, and the mitotic

index of the test article solutions showed no significant difference from the controls.

The test article extracts showed no significant increase of aberrations when compared to the negative controls. The test article is not considered to be genotoxic when exposed to CHO cells.

All test method acceptance criteria were met.