Fatty acids tall-oil, reaction products with acrylic acid, potassium salt

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:

23 April 1991 to 28 May 1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Ames et al. (1975)

Deviations:

no

Principles of method if other than guideline:

not applicable

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Diacid 1550

IUPAC Name:

Diacid 1550

Details on test material:

- Name of test material (as cited in study report): Diacid 1550
- Physical state: Liquid
- Lot/batch No.: Confidential

Method

Target gene:

His-gene (HisG 46, HisC 3076, HisD 3052)

Species / strain

Species / strain 1

Species / strain / cell type:

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

Details on mammalian cell type (if applicable):

not applicable

Additional strain / cell type characteristics:

not specified

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 1538

Details on mammalian cell type (if applicable):

not applicable

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

mammalian liver S9

Test concentrations with justification for top dose:

2.5 and 8 µL of a 10 mg/L solution
2.5, 8, and 25 µL of a 100 mg/L

Vehicle / solvent:

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

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

2-nitrofluorene

other: 2-anthramine, N-methyl-N-nitro-N-nitrosoguanidine

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Preincubation period: not applicable
- Exposure duration: 48 ±4 hours

SELECTION AGENT (mutation assays): Agar containing Histidine

NUMBER OF REPLICATIONS: experiments performed in triplicate

NUMBER OF CELLS EVALUATED: no data available

DETERMINATION OF CYTOTOXICITY
- Method: relative total growth (number of revertant colonies per plate) in TA100

Evaluation criteria:

The average number of revertant colonies (± the standard deviation) per plate is tabulated. A positive reponse is indicated if a sample substance produces a consistent bacterial response which is two times that of the solvent or spontaneous reversions for TA 98 and TA 100. For the strains TA 15335, TA 1537 and TA 1538, a sample producing a consistent bacterial reponse three times that of the solvent or spontaneous control is indicated as positive.

Statistics:

No information available

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:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Remarks:

100 mg/mL induced cytotoxicity in TA 100

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: sample was not soluble above 100 mg/mL in dimethylsulfoxide

RANGE-FINDING/SCREENING STUDIES: Sample was diluted in dimethylsulfoxide and tested for cytoxicity in TA 100; 100 mg/mL induced cytotoxicity

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Average test results per strain ± standard deviation with activation:

Tester Strain	Solvent control	Positive control	10 mg/mL		100 mg/mL
			2.5 µL	8 µL	2.5 µL	8 µl	25 µl
TA 98	28±2	3842±935	28±5	23±6	28±6	30±8	28±6
TA 100	88±3	2894±176	82±12	75±15	56±9	61±16	53±13
TA 1535	13±1	589±200	14±2	8±3	8±2	11±6	11±3
TA 1537	15±2	135±32	14±4	19±0	31±5	14±6	2±1
TA 1538	28±3	461±254	24±3	16±5	24±3	20±5	41±25

 

Average test results per strain ± standard deviation without activation:

Tester Strain	Solvent control	Positive control	10 mg/mL		100 mg/mL
			2.5 µL	8 µL	2.5 µL	8 µl	25 µl
TA 98	14±5	1443±93	10±3	16±3	11±4	11±4	11±5
TA 100	43±2	2764±79	33±7	29±4	32±10	32±10	27±6
TA 1535	32±4	1386±33	26±6	20±3	4±3	5±2	8±5
TA 1537	38±16	1973±606	42±7	19±6	10±3	4±2	3±2
TA 1538	28±20	1024±213	6±1	4±2	4±2	2±2	2±1

 

Applicant's summary and conclusion

Conclusions:

In this Ames test, Diacid 1550 did not show any mutagenic activity in the Salmonella Typhimurium strains TA98, TA100, TA1535, TA1537 and TA1538 with and without activitation under the conditions of this test.

Executive summary:

In this study the ability of Diacid 1550 to induce mutations in the Salmonella Typhimurium strains TA98, TA100, TA1535, TA1537 and TA1538 was investigated. The study procedures used in this study were based on the Ames Test as described by Ames et al. (1975).

The samples were diluted in dimethylsulfoxide and were incubated on agar plates for 48 ±4 hours at 37 °C (plate incorporation assay). After incubation, the agar plates were examined for the average number of revertant colonies. Prior to the Ames test, a cytoxicity test was performed in TA100 restulting in a cytoxic dose of 100 mg/mL.

Diacid 1550 dit not show any mutagenic activity up to limit concentrations in the Salmonella Typhimurium strains TA98, TA100, TA1535, TA1537 and TA1538 with and without activitation under the conditions of this test.