Glycerides, C14-18 and C16-18-unsatd. mono-, di- and tri-

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

weight of evidence

Study period:

20 Jun - 29 Jun 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP-Guideline study with acceptable restrictions. No TA102 or E. coli strain included.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

no TA102 or E. coli strain included

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Glycerides, C14-18 and C16-22-unsatd. mono- and di-

EC Number:

294-574-1

EC Name:

Glycerides, C14-18 and C16-22-unsatd. mono- and di-

Cas Number:

91744-13-7

IUPAC Name:

91744-13-7

Details on test material:

- Name of test material (as cited in study report): only trade name given
- Chemical denomination: Glyceride, C14-18 and C16-22 unsaturated, mono- and di-
- Batch number: 0189-0-040
- Physical state: clear, yellow-brown liquid
- Analytical purity: approx. 100%
- Receipt of test substance: 1990-03-20

Method

Target gene:

his operon

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:

S. typhimurium TA 1538

Metabolic activation:

with and without

Metabolic activation system:

cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Aroclor 1254.

Test concentrations with justification for top dose:

First and second experiment: 8, 40, 200, 1000, 5000 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: Tween 80/bidist. water
- Justification for choice of solvent/vehicle: The suspension medium was chosen according to the solubility properties tested preliminary before start of the study.

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: without S9: sodium azide (2 µg/plate) for TA100 and TA1535, 9-aminoacridine (80 µg/plate) for TA1537, 4-nitro-o-phenylendiamine (40 µg/plate) for TA98 and TA1538; with S9: 2-aminoanthracene (2.5 or 5 µg/plate) for all strains

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 48 h

NUMBER OF REPLICATIONS: triplicates each in 2 independent experiments

DETERMINATION OF CYTOTOXICITY
- Method: background lawn and/or reduced number of revertants versus negative control

Evaluation criteria:

The results were considered positive if the following criteria were met:
- the plate background of not-reverted bacteria did not show any no growth reduction in comparison to the respective negative controls,
- the spontaneous mutation rates of each tester strain per plate were within the characteristic spontaneous mutation range,
- the positive controls showed mutation rates exceeding the control values of TA100 at least by the factor 2 and those of the other tester strains at least by the factor 3,
-at more than one dose tested, the test substance caused at least a 2-fold increase in comparison with the negative controls in the tester strain TA100. For the other tester strains, an increase in the mutation rate of more than 3 above the corresponding negative controls was considered positive.

Statistics:

Mean values and standard deviation were calculated.

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

Remarks:

5000 µg/plate: TA 1535

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

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:

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

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Table 1: Ames Test Results - experiment 1

With or without S9-Mix	Test substance concentration (μg/plate)	Mean number of revertant colonies per plate (average of 3 plates)
		Base-pair substitution type			Frameshift type
		TA 1535	TA 1538	TA 100	TA 98	TA 1537
-	Negative control (water)	8.3	11.0	72.7	28.0	7.7
-	0 (Solvent control)	8.0	11.0	80.3	27.7	6.3
-	8	11.3	11.7	69.7	31.3	8.7
-	40	9.0	11.0	71.7	28.0	6.7
-	200	11.3	8.3	60.0	34.0	5.0
-	1000	8.3	6.7	55.0	24.0	4.7
-	5000	3.7*	6.3	56.7	25.0	4.7
Positive controls - S9	Name	SA	4NP	SA	4NP	9AA
	Concentrations (μg/plate)	2	40	2	40	80
	Number of colonies/plate	251.0	1262.7	207.0	762.3	581.7
+	Negative control (water)	9.7	14.7	69.3	26.7	6.7
+	0 (Solvent control)	9.0	14.7	79.7	29.0	9.0
+	8	9.7	18.7	75.0	32.3	9.0
+	40	9.7	11.7	79.0	30.7	8.0
+	200	11.7	13.7	68.0	30.0	11.0
+	1000	10.3	16.0	73.3	28.3	7.7
+	5000	3.7*	12.7	53.7	24.3	6.3
Positive controls + S9	Name	2AA	2AA	2AA	2AA	2AA
	Concentrations (μg/plate)	2.5	5	5	5	2.5
	Number of colonies/plate	135.7	1403.3	1509.0	1799.7	1654.3

* Partial inhibition of bacterial background lawn

SA = Sodium azide

4NP = 4-Nitro-o-phenylendiamine

9AA = 9-Aminoacridine

2AA = 2-Aminoanthracene

 

Table 2: Ames Test Results - experiment 2

With or without S9-Mix	Test substance concentration (μg/plate)	Mean number of revertant colonies per plate (average of 3 plates)
		Base-pair substitution type			Frameshift type
		TA 1535	TA 1538	TA 100	TA98	TA1537
-	Negative control (water)	10.7	12.3	67.7	28.7	6.3
-	0 (Solvent control)	11.7	13.0	72.3	29.3	6.3
-	8	10.3	14.0	68.7	28.0	5.7
-	40	13.7	8.3	75.7	26.0	7.0
-	200	7.3	8.0	54.7	24.7	4.3
-	1000	7.3	8.0	53.7	26.3	4.0
-	5000	2.7*	8.3	46.3	28.7	1.7
Positive controls - S9	Name	SA	4NP	SA	4NP	9AA
	Concentrations (μg/plate)	2	40	2	40	80
	Number of colonies/plate	274.0	1410.0	192.0	738.0	646.7
+	Negative control (water)	13.0	19.7	78.7	37.7	10.3
+	0 (Solvent control)	14.3	20.7	82.7	40.0	9.0
+	8	13.7	20.7	76.0	32.7	9.7
+	40	14.7	16.3	85.0	35.7	10.0
+	200	11.7	16.0	75.3	38.7	7.7
+	1000	13.7	18.7	72.0	36.3	6.7
+	5000	7.7*	14.3	61.3	34.7	3.3
Positive controls + S9	Name	2AA	2AA	2AA	2AA	2AA
	Concentrations (μg/plate)	2.5	5	5	5	2.5
	Number of colonies/plate	218.3	1413.3	1280.3	1637.0	1993.3

* Partial inhibition of bacterial background lawn

SA = Sodium azide

4NP = 4-Nitro-o-phenylendiamine

9AA = 9-Aminoacridine

2AA = 2-Aminoanthracene

 

 

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative