Bis(2,2,6,6-tetramethyl-4-piperidyl) sebacate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From Jul. 16, 1980 to Sep. 8, 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

No independent repeat test conducted.

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of Bis(1,2,2,6,6-pentamethyl-4-piperidyl) sebacate and Methyl 1,2,2,6,6-pentamethyl-4-piperidyl sebacate

EC Number:

915-687-0

Molecular formula:

unspecified

IUPAC Name:

Reaction mass of Bis(1,2,2,6,6-pentamethyl-4-piperidyl) sebacate and Methyl 1,2,2,6,6-pentamethyl-4-piperidyl sebacate

Method

Target gene:

Histidine (his- to his+) and tryptophan (tryp- to tryp+) genes in Salmonella typhimurium and Escherichia coli respectively.

Species / strain

Species / strain / cell type:

other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98, TA 100 and E. coli WP2 uvr A

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254-induced rat liver S9

Test concentrations with justification for top dose:

Toxicity test (performed on strain TA 100): 0.0001, 0.001, 0.01, 0.1, 1, 10, 50, 100, 500, 1000, and 2000 µg/0.1 mL.
Experiment (performed on all strains): 5, 10, 50, 100, 500, 1000, and 5000 µg/0.1 mL.

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: None provided.
Method for suspension of refractory substances: Ultrasonication

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: See Table 1

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 48 - 55 hours at 37 degrees C.

NUMBER OF REPLICATIONS: 3 Petri dishes/strain/group.

DETERMINATION OF CYTOTOXICITY
- Method: relative total growth

Evaluation criteria:

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

Statistics:

When the colonies had been counted, the arithmetic mean was calculated. Statistical analysis was not performed.

Results and discussion

Test results

Species / strain:

other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98, TA 100 and E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: At the concentrations of 500, 1,000, and 5,000 µg/0.1mL, the substance precipitated in soft agar.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

DETAILS ON EXPERIMENTAL RESULTS:

In the experiments performed without and with microsomal activation, comparison of the number of back-mutant colonies in the controls and the cultures treated with the various concentrations of the test article revealed no marked deviations.

	TA 98		TA 100		TA 1535		TA 1537		TA 1538		WP2uvrA
Dose (µg/0.1 ml)	-S9	+S9	-S9	+S9	-S9	+S9	-S9	+S9	-S9	+S9	-S9	+S9
solvent control	27	53	166	106	12	7	4	10	9	31	24	25
5	14	39	155	109	8	10	6	12	9	30	23	21
10	18	59	154	99	10	8	4	12	11	31	22	12
50	16	50	157	102	11	10	5	13	13	30	21	21
100	21	42	146	93	11	11	5	5	9	37	23	19
500	19	50	137	90	8	12	3	12	5	38	17	17
1000	15	55	171	101	10	9	2	13	10	27	16	17
5000	15	65	142	94	5	10	0	7	5	28	17	11
positive controls:
solvent control	17	45	180	146	11	12	11	17	9	32	19	15
concentration A	385	1163	712	1131	>1500	530	136	73	~1100	374	318	617
concentration B	533	1261	1187	1932	>2000		1000	52	>1500	280	430	764

For details on positive controls see table 1 above.

Applicant's summary and conclusion

Conclusions:

No evidence for a mutagenic effect was obtained in Salmonella strains TA 98, TA 100, TA 1535, TA 1537 and TA 1538 and E.coli strain WP2 uvr A treated with up to 5000 µg/plate in experiments with and without microsomal activa¬tion.