1,2,3-Propanetriol, homopolymer, docosanoate

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:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Polyglycerintribehenat

IUPAC Name:

Polyglycerintribehenat

Details on test material:

- Name of test substance: Polyglycerintribehenat
- Batch No.: Partie 29
- Date of manufacturing: February 2, 1996
- Degree of purity/Composition: 85.8% behenic acid bound as behenic ester, 13.0% polyglycerin
- Appearance, consistency: Beige, solidified melt
- Storage: Room temperature

Method

Species / strain

Species / strain 1

Species / strain / cell type:

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

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A

Metabolic activation:

with and without

Metabolic activation system:

Aroclor-induced rat liver S-9 mix

Test concentrations with justification for top dose:

0; 20; 100; 500; 2500 and 5000 µg/plate

Vehicle / solvent:

- Vehicle/solvent used: tetrahydrofurane (THF)

Controls

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Remarks:

W/ S-9 mix: 2.5 µg/plate (Salmonella strains) or 60 µg/plate (E. coli strain) 2-AA; w/o S-9 mix: 5 µg/plate MNNG (TA 100, TA 1535), 10 µg/plate NOPD (TA 98), 100 µg/plate AAC (TA 1537), 10 µg/plate ENNG (E.coli WP2 uvrA)

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation).

NUMBER OF REPLICATIONS: 2 independent experiments with 3 test plates per dose or per control.

DETERMINATION OF CYTOTOXICITY: decrease in the number of revertants.

Evaluation criteria:

In general, a substance to be characterized as positive in the bacterial tests has to fulfill the following requirements:
- doubling of the spontaneous mutation rate (control)
- dose-response relationship
- reproducibility of the results.

Results and discussion

Test results

Test results 1

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:

cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: A test substance precipitation was found from about 100 µg/plate onward.

ADDITIONAL INFORMATION ON CYTOTOXICITY: Aslight decrease in the number of revertants was occasionally observed depending on the strain and test conditions from about 500 µg - 2500 µg/plate onward.

Any other information on results incl. tables

Results of Standard plate test (SPT) – Experiment 1/2:

Dose/plate (µg)	Without S-9 mix		With S-9 mix
	Mean	SD	Mean	SD
Salmonella typhimurium TA 1535
0 (THF)	19/22	2/3	21/20	5/1
20	17/20	1/2	23/17	4/1
100	17P/18P	4/0	19P/19P	3/1
500	14P/19P	2/2	15P/15P	3/1
2500	5P/17P	1/4	13P/14P	2/2
5000	6P/12P	1/2	12P/12P	3/2
MNNG 5.0 µg	1361/866	73/110
2-AA 2.5 µg			145/133	27/26
Salmonella typhimurium TA 100
0 (THF)	118/121	9/2	111/142	8/1
20	120/120	7/11	113/130	6/12
100	118P/112P	7/18	98P/134P	8/9
500	91P/87P	8/7	64P/130P	7/6
2500	77P/67P	10/6	55P/132P	6/9
5000	69P/50P	16/2	43P/117P	8/6
MNNG 5.0 µg	1246/896	184/70
2-AA 2.5 µg			772/1128	29/43
Salmonella typhimurium TA 1537
0 (THF)	10/10	1/2	11/11	2/1
20	11/10	4/3	10/9	3/2
100	6P/8P	2/1	9P/9P	3/2
500	8P/7P	3/1	16P/5P	4/1
2500	9P/6P	2/1	11P/4P	1/1
5000	8P/2P	1/1	9P/3P	3/2
AAC 100.0 µg	102/670	23/46
2-AA 2.5 µg			483/118	29/7
Salmonella typhimurium TA 98
0 (THF)	34/23	9/4	28/36	6/4
20	32/21	4/2	28/31	2/2
100	34P/17P	2/4	27P/25P	5/3
500	23P/15P	5/2	23P/15P	2/3
2500	15P/9P	4/2	24P/17P	5/4
5000	11P/8P	4/2	25P/14P	9/2
NOPD 10.0 µg	855/1304	67/95
2-AA 2.5 µg			1121/567	37/42
Escherichia coli WP2 uvrA
0 (THF)	33/30	5/1	40/35	2/2
20	38/29	2/3	44/34	3/1
100	38P/30P	6/4	40P/25P	3/3
500	39P/26P	3/3	36P/31P	8/5
2500	28P/23P	1/1	37P/30P	6/4
5000	30P/23P	3/2	35P/28P	3/2
ENNG 10.0 µg	532/525	36/28
2-AA 60 µg			244/201	26/9

P: Precipitation

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

According to the results of this study, the test substance is not mutagenic in the Ames test and in the Escherichia coli-reverse mutation assay without or with metabolic activation.

Executive summary:

The test substance was tested for its mutagenic potential based on the ability to induce back mutations in selected loci of several bacterial strains in the Ames test and in the Escherichia coli-reverse mutation assay according to OECD guidelines 471 and 472 in compliance with GLP.

- Strains: TA 1535, TA 100, TA 1537, TA 98 and E. coli WP2 uvrA

- Dose range: 20 µg - 5000 µg/plate

- Test conditions: Standard plate test both with and without metabolic activation (Aroclor-induced rat liver S-9 mix)

- Solubility: A precipitation of the test substance was found from about 100 µg/plate onward.

- Toxicity: A slight decrease in the number of revertants was occasionally observed depending on the strain and test condition from about 500 µg - 2500 µg/plate onward.

- Mutagenicity: An increase in the number of his+ or trp+ revertants was not observed in the standard plate test either without S-9 mix or after the addition of a metabolizing system.

Conclusions: According to the results of this study, the test substance is not mutagenic in the Ames test and in the Escherichia coli-reverse mutation assay without or with metabolic activation.