2,2-bis(hydroxymethyl)-1,3-propanediyl dioleate

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:

key study

Study period:

16 July - 27 July 1991

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study with acceptable restrictions (Strain S. typhimurium TA102 or E.coli WP2 were not tested).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

Strain S. typhimurium TA102 or E.coli WP2 not tested.

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C16-18, esters with pentaerythritol

EC Number:

285-547-5

EC Name:

Fatty acids, C16-18, esters with pentaerythritol

Cas Number:

85116-93-4

IUPAC Name:

85116-93-4

Details on test material:

- Name of test material (as cited in study report): fatty acid C16-18, ester with pentaerythriol
- Physical state: white, solid, powder
- Analytical purity: 99%
- Lot/batch No.: 51531022
- Stability under test conditions: 18 months
- Storage condition of test material: room temperature

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

Additional strain / cell type characteristics:

other: rfa-, uvR-, Strains 98 and 100 also R+

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 1538

Additional strain / cell type characteristics:

other: rfa-, uvR-

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:

8, 40, 200, 1000 and 5000 µg/plate

Controls

Controls 1

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

2 µg/plate; TA100 and TA1535 (-S9)

Controls 2

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

80 µg/plate; TA1537 (-S9)

Controls 3

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 4-nitro-o-phenylendiamine

Remarks:

40 µg/plate; TA98 and TA1538 (- S9)

Controls 4

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-Aminoanthracene

Remarks:

all strains with metabolic activation; 2.5 µg/plate: TA1535, TA1537; 5 µg/plate: TA100, TA1538, TA98

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, but tested up to precipitating concentrations

Remarks:

Precipitate was seen at concentrations of 1000 µg/plate and higher

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:

no cytotoxicity, but tested up to precipitating concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

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: Mutagenicity of the test item on bacteria - experiment I

 

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 100	TA1535	TA1538	TA98	TA1537
-	Buffer	116	9	10	22	7
	Vehicle	112	11	12	34	10
-	8	114	10	7	29	10
-	40	111	10	8	34	7
-	200	114	8	9	29	8
-	1000	120	12	7	25	6
-	5000	132	6	9	29	6
Positive controls - S9	Name	SA	SA	4NP	4NP	9AA
	Concentrations (μg/plate)	2.0	2.0	40	40	80
	Number of colonies/plate	818	621	1792	1571	1025
+	Buffer	116	11	15	38	6
+	Vehicle	103	12	15	35	10
+	8	115	12	16	34	8
+	40	120	9	11	39	8
+	200	113	12	13	38	10
+	1000	126	11	14	39	7
+	5000	130	13	12	3934	7
Positive controls + S9	Name	2AA	2AA	2AA	2AA	2AA
	Concentrations (μg/plate)	5.0	2.5	5.0	5.0	2.5
	Number of colonies/plate	1594	210	1769	1572	66

 

4NP= 4-nitro-o-phenylendiamine

SA = sodium azide

9AA = 9 -aminoacridine

2AA = 2 -aminoanthracene

 

 

 

Table 2: Mutagenicity of the test item on bacteria - experiment II

 

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 100	TA1535	TA1538	TA98	TA1537
-	Buffer	122	11	13	34	6
	Vehicle	127	13	9	39	13
-	8	116	12	11	30	10
-	40	110	14	12	31	8
-	200	121	13	14	39	5
-	1000	111	17	18	29	7
-	5000	122	16	13	32	10
Positive controls - S9	Name	SA	SA	4NP	4NP	9AA
	Concentrations (μg/plate)	2.0	2.0	40	40	80
	Number of colonies/plate	1018	824	1929	1643	1017
+	Buffer	127	15	19	40	9
+	Vehicle	116	21	20	43	10
+	8	128	11	19	46	10
+	40	126	17	19	49	6
+	200	115	13	19	45	9
+	1000	121	19	16	49	10
+	5000	127	21	14	40	7
Positive controls + S9	Name	2AA	2AA	2AA	2AA	2AA
	Concentrations (μg/plate)	5.0	2.5	5.0	5.0	2.5
	Number of colonies/plate	1535	327	1384	1515	64

 

4NP= 4-nitro-o-phenylendiamine

SA = sodium azide

9AA = 9 -aminoacridine

2AA = 2 -aminoanthracene

 

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative