Octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline with acceptable restrictions (neither TA102 or WP2uvrA strains were used to detect cross-linking mutagens, positive control with S9-mix tested only with TA100, no result of positive control was reported)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

neither TA102 or WP2uvrA strains were used to detect cross-linking mutagens, positive control with S9-mix tested only with TA100, no result of positive control was reported

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate

EC Number:

218-216-0

EC Name:

Octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate

Cas Number:

2082-79-3

Molecular formula:

C35H62O3

IUPAC Name:

octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate

Method

Target gene:

Salmonella typhimurium: histidine operon

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Metabolic activation system:

with S9 mix (S9 fraction of liver from rats induced with Aroclor 1254 plus co-factors)

Test concentrations with justification for top dose:

without S9 mix: 10, 25, 50, 100 and 250 µg/0.1 ml;
with S9 mix: 5, 10, 25, 50 and 100 µg/0.1 ml.

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

cyclophosphamide

Remarks:

with S9 mix

Migrated to IUCLID6: 100 and 250 µg/0.1 ml physiological saline for TA100

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

NUMBER OF REPLICATIONS: 3

OTHER: Positive control experiments in the form of Spot Tests were carried out simultaneously with the following substances: N-methyl-N'-nitro- N-nitrosoguanidine (2µg/0.1 ml for TA1535), 9-aminoacridine (100 µg/0.1 ml for TA1537), daunoblastin (50 µl/0.1 ml for TA98), 4-nitroquinoline-n-oxide (10 µl/0.1 ml for TA100).

Evaluation criteria:

When the colonies had been counted, the arithmetic mean was calculated. The test substance was considered to be non-mutagenic if the colony count in relation to the negative control was not doubled at any concentration.

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity, but tested up to precipitating concentrations

Vehicle controls validity:

valid

Positive controls validity:

not specified

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Mean number of colonies of histidine-prototrophic back-mutants (without S9 mix)

Dose group	TA98	TA100	TA1535	TA1537
Control	21	116	13	5
10 µg/0.1 ml	27	96	18	5
25 µg/0.1 ml	25	103	20	7
50 µg/0.1 ml	28	95	14	6
100 µg/0.1 ml*	22	107	15	3
250 µg/0.1 ml*	24	94	16	7

 

Mean number of colonies of histidine-prototrophic back-mutants (with S9 mix)

Dose group	TA98	TA100	TA1535	TA1537
Control	34/29	208/190	22/19	10/9
5 µg/0.1 ml	30/36	187/169	19/19	6/7
10 µg/0.1 ml	26/30	194/172	16/22	8/7
25 µg/0.1 ml	35/30	197/196	20/22	8/10
50 µg/0.1 ml*	39/31	193/197	17/16	8/10
100 µg/0.1 ml*	32/36	162/188	16/20	8/9

n/n: first figures are values without, second figures values with pre-incubation.

* Precipitation

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

No evidence of the induction of point mutations by the test compound or by the metabolites of the substance formed as a result of microsomal activation was detectable in the strains of S. typhimurium used in these experiments.