α-tocopheryl hydrogen succinate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

α-tocopheryl hydrogen succinate

EC Number:

224-403-8

EC Name:

α-tocopheryl hydrogen succinate

Cas Number:

4345-03-3

Molecular formula:

C33H54O5

IUPAC Name:

4-oxo-4-{[2,5,7,8-tetramethyl-2-(4,8,12-trimethyltridecyl)-3,4-dihydro-2H-chromen-6-yl]oxy}butanoic acid

Test material form:

not specified

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 1537

Species / strain 3

Species / strain / cell type:

S. typhimurium TA 97

Species / strain 4

Species / strain / cell type:

S. typhimurium TA 98

Metabolic activation system:

S9

Test concentrations with justification for top dose:

concentrations for all test strains: 100, 333, 1000, 3333, 10000 μg/plate

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Positive controls:

yes

Positive control substance:

9-aminoacridine

sodium azide

other: 2-Aminoantracene, 4-nitro-o-phenyl- enediamine

Details on test system and experimental conditions:

S9 in the S9 mixture (metabolic activation enzymes and cofactors from Aroclor 1254-induced male Sprague-Dawley rat or Syrian hamster liver).

Results and discussion

Test results

Test results 1

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

Test results 2

Key result

Species / strain:

S. typhimurium TA 1537

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

Test results 3

Key result

Species / strain:

S. typhimurium TA 97

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

Test results 4

Key result

Species / strain:

S. typhimurium TA 98

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

Any other information on results incl. tables

Concentration denotes the the percentage of S9 in the S9 mixture (metabolic activation enzymes and cofactors from Aroclor 1254-induced male Sprague-Dawley rat or Syrian hamster liver) that was added to cultures.

Strain: TA100
S9 Activation	S9 Species	Concentration
No Activation	N/A	N/A
30% RLI	Rat	30%
30% HLI	Hamster	30%
10% RLI	Rat	10%
10% HLI	Hamster	10%
Strain: TA1535
S9 Activation	S9 Species	Concentration
No Activation	N/A	N/A
30% RLI	Rat	30%
30% HLI	Hamster	30%
10% RLI	Rat	10%
10% HLI	Hamster	10%
Strain: TA97
S9 Activation	S9 Species	Concentration
No Activation	N/A	N/A
30% RLI	Rat	30%
30% HLI	Hamster	30%
10% RLI	Rat	10%
10% HLI	Hamster	10%
Strain: TA98
S9 Activation	S9 Species	Concentration
No Activation	N/A	N/A
30% RLI	Rat	30%
30% HLI	Hamster	30%
10% RLI	Rat	10%
10% HLI	Hamster	10%

Applicant's summary and conclusion

Conclusions:

Under the study conditions, the test substance is not mutagenic in the Salmonella typhimurium strains TA 97a, TA 98, TA 100 and TA 1535 in absence and presence of metabolic activation.

Executive summary:

A study was conducted to determine the mutagenic potential of the test substance according to Bacterial Reverse Mutation Test. The test substance was examined using four strains of Salmonella typhimurium (TA 97a, TA 98, TA 100 and TA 1535). The test was performed in the presence and absence of S9-mix (Sprague-Dawley rat or Syrian hamster liver S9-mix induced by Aroclor 1254). 5 concentrations were used for all test strains: 100, 333, 1000, 3333 and 10000 μg/plate. Positive and negative controls were included in the study. No significant increase of the number of revertant colonies could be observed at any of the treatment concentrations. Under the study conditions, the test substance was not mutagenic in the Salmonella typhimurium strains TA 97a, TA 98, TA1 00 and TA 1535 in absence and presence of metabolic activation (NTP, 1985).