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Toxicological information

Genetic toxicity: in vitro

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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

Constituent 1
Reference substance name:
Reaction mass of docosanoic acid and icosanoic acid and linoleic acid and linolenic acid and oleic acid and palmitic acid and stearic acid
EC Number:
946-247-6
Molecular formula:
Not relevant for a UVCB substance
IUPAC Name:
Reaction mass of docosanoic acid and icosanoic acid and linoleic acid and linolenic acid and oleic acid and palmitic acid and stearic 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
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated 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.