12-hydroxyoctadecanoic acid, reaction products with 1,3-benzenedimethanamine and hexamethylenediamine

Genetic toxicity: in vitro

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Administrative data

Endpoint:

in vitro gene mutation study in mammalian cells

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)

Deviations:

no

Principles of method if other than guideline:

Not applicable

Test material

Test material information

Constituent 1

Method

Target gene:

The thymidine kinase (tk) gene.

Species / strain

Species / strain / cell type:

mouse lymphoma L5178Y cells

Details on mammalian cell type (if applicable):

- Type and identity of media: RPMI A, 10 and 20
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: no data
- Periodically "cleansed" against high spontaneous background: no data

Additional strain / cell type characteristics:

not specified

Test concentrations with justification for top dose:

In the cytotoxicity Range-Finder Experiment, six concentrations were tested, in the absence and presence of S 9, ranging from 12.5 to 400 µg/mL (limited by solubility in culture medium).
In Experiment 1, eleven concentrations, ranging from 10.0 to 500 µg/mL in the absence and presence of S 9.
In Experiment 2, ten concentrations were tested, ranging from 20 to 250 µg/mL in the absence of S-9 and from 20 to 300 µg/mL in presence of S 9.
(see table 7.6.1/1)

Results and discussion

Test results

Species / strain:

mouse lymphoma L5178Y cells

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity, but tested up to precipitating concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: other: TK locus

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Table 7.6.1/4: RTG Values - 3 hour Range-Finder Experiment

Treatment (µg/mL)	-S-9 % RTG	+S-9 % RTG
0	100	100
12.5	113	42
25.0	60	66
50.0	68	47
100	82 P	62 P
200	70 P	54 P
400	61 P, PP	47 P, PP

 

% RTG                    Percentage Relative Total Growth

P                          Precipitation observed at time of treatment

PP                        Precipitation observed following 3 -hour treatment incubation period

Table 7.6.1/5: Summary of mutation data

Experiment 1 (3 hour treatment in the absence and presence of S-9)

Treatment (µg/mL)		-S-9				Treatment (µg/mL)		+S-9
		% RTG		MF§				% RTG		MF§
0		100		93.92		0		100		90.67
20.0		82		72.75		40		89		87.02
40.0		93		84.15		60		90		74.80
60.0		83		90.44		80	P	102		73.37
80.0	P	95		94.77		120	P	84		89.88
120	P	84		84.67		160	P	84		78.18
160	P, PP	88		90.88		200	P, PP	96		71.57
Linear trend				NS		Linear trend				NS
MMS						B[a]P
15		39		1011.08		2		64		765.35
20		27		1654.27		3		33		1276.74

 

Experiment 2 (3 hour treatment in the absence and presence of S-9)

Treatment (µg/mL)		-S-9				Treatment (µg/mL)		+S-9
		% RTG		MF§				% RTG		MF§
0		100		73.09		0		100		73.78
20.0		120		46.91		20		99		58.47
40.0		110		73.88		40		99		65.79
60.0	P	116		63.55		80	P	90		62.05
80.0	P	104		75.45		120	P	91		79.37
100	P	99		75.99		140	P	107		70.09
120	P	99		54.48		160	P	112		69.45
140	P, PP	126		50.26		180 $$	P, PP	93		67.54
Linear trend				NS		Linear trend				NS
MMS						B[a]P
15		65		772.15		2		62		532.53
20		35		1301.88		3		37		1026.62

MF         Mutant frequency

§             5‑TFT resistant mutants/10⁶viable cells 2 days after treatment

% RTG  Percentage Relative Total Growth

NS         Not significant

P            Precipitation observed at time of treatment

PP          Precipitation observed following 3 -hour treatment incubation period

$$           Heterogeneity observed. Concentration retained for comparative purposes