Oxidized Corn oil

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Remarks:

OCDE 471

Adequacy of study:

key study

Study period:

13th to 19th March 2012

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

as the tested product is not the registered substance.

Justification for type of information:

As an ingredient used in medical devices, tests and protocols established from the O.E.C.D. guideline and International standard NF EN ISO 10993-10 concerning biological evaluation of medical devices are already available.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

not specified

Remarks:

SD: standard deviation

GLP compliance:

no

Remarks:

in accordance with ISO/CEI 17025 standard (2005) and the COFRAC program no129.

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of palmitic acid and stearicacid and linoleic acid and oleic acid and docosanoic acid and linolenic acid and icosanoic acid

Molecular formula:

Not relevant for a UVCB substance

IUPAC Name:

Reaction mass of palmitic acid and stearicacid and linoleic acid and oleic acid and docosanoic acid and linolenic acid and icosanoic acid

Test material form:

semi-solid (amorphous): gel

Details on test material:

batch 801026

Specific details on test material used for the study:

Gel for genital Herpes, reference: CS21, batch : 801026

Method

Target gene:

TA98 : hisD3052, frameshift
TA100 : hisG46, missense
TA1535 : hisG46, missense
TA1537 : hisC3076, frameshist
WP2uvrA : trpE65, missence

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

mammalian metabolic activation

Test concentrations with justification for top dose:

0.1 ml per plate

Vehicle / solvent:

0.9 % sodium chloride solution (NaCl) and in Dimethyl Sulfoxide (DMSO)

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Positive controls:

yes

Positive control substance:

9-aminoacridine

2-nitrofluorene

sodium azide

benzo(a)pyrene

ethylmethanesulphonate

methylmethanesulfonate

other: 2-aminoanthracene

Details on test system and experimental conditions:

extracted at 37°C
tester strains were purchased from Trinova Biochem USA
TA98
TA100
TA1535
TA1537
WP2uvrA
see attached document on part 3 page 7

Results and discussion

Test results

Test results 1

Key result

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: 0.1 mL /plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

True negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Key result

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: 0.1 mL /plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

True negative controls validity:

valid

Positive controls validity:

valid

Test results 3

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: 0.1 mL per plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

True negative controls validity:

valid

Positive controls validity:

valid

Test results 4

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: 0.1 mL /plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

True negative controls validity:

valid

Positive controls validity:

valid

Test results 5

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: 0.1 mL /plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

True negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

The DMSO test article extract and NaCl test article extract were considered to be non-mutagenic to S. typhimurium tester strains TA98, TA 100, TA1535, and TA 1537 and to E.coli tester strain WP2vrA.