Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP-Guideline study. Tested with the source substance 2,3-dihydroxypropyl oleate. According to the ECHA guidance document 'Practical guide 6: How to report read-across and categories (ECHA, 2012)', the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
Qualifier:
according to guideline
Guideline:
JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
Deviations:
no
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
2,3-dihydroxypropyl oleate
EC Number:
203-827-7
EC Name:
2,3-dihydroxypropyl oleate
Cas Number:
111-03-5
IUPAC Name:
2,3-dihydroxypropyl octadec-9-enoate
Details on test material:
- Name of test material (as cited in study report): glycerol monooleate
- Physical state: light yellow pellets with characteristic odour
- Analytical purity: 99.93%
- Stability under test conditions: verified after test

Method

Target gene:
his operon (for S. typhimurium strains)
trp operon (for E. coli strain)
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with phenobarbital and 5,6-benzoflavone
Test concentrations with justification for top dose:
-S9 mix:
4.88, 9.77, 19.5, 39.1, 78.1, 156 μg/plate (TA100, TA98)
156, 313, 625, 1250, 2500, 5000 μg/plate (TA1535, WP2 uvrA)
0.153, 0.305, 0.610, 1.22, 2.44, 4.88, 9.77 μg/ plate (TA1537)

+S9 mix:
9.77, 19.5, 39.1, 78.1, 156, 313, 625 μg/plate (TA100)
156, 313, 625, 1250, 2500, 5000 μg/plate (TA1535, WP2 uvrA, TA98)
9.77, 19.5, 39.1, 78.1, 156, 313 μg/plate (TA1537)
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The test substance was not soluble in water.
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: -S9: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide (AF2; 0.01 or 0.1 µg/plate, TA100, TA98, E. coli); sodium azide (SA; 0.5 µg/plate, TA1535); 9-aminoacridine (9AA; 80 µg/plate, TA1537); +S9: 2-Aminoanthracene (2AA; 0.5-10 µg/plate, all strains)
Details on test system and experimental conditions:
METHOD OF APPLICATION: Pre-incubation method

DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h

NUMBER OF REPLICATIONS: 3 replications in one experiment

DETERMINATION OF CYTOTOXICITY
- Method: Inspection of the bacterial background lawn




Evaluation criteria:
Revertant colonies were counted for 3 plates per bacterial strain. The test result was considered positive, if the mean value out of 3 plates was at least twice as high as the negative vehicle control and a dose-dependency was found.
Statistics:
Mean values and standard deviation were calculated.

Results and discussion

Test resultsopen allclose all
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:
-S9: at 3.13 (TA1537), 78.1 (TA98) and 100 (TA100) µg/plate and above; +S9: at 128 (TA1537) and 156 (TA100) µg/plate and above
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Species / strain:
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 specified
Positive controls validity:
valid
Additional information on results:
TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: the test substance was not soluble in water.
- Precipitation: in the dose-finding studies and the main study, precipitation was observed at the end of the exposure period at ≥ 625 and ≥ 1250 µg/plate in the presence and absence of metabolic activation, respectively.

RANGE-FINDING/SCREENING STUDIES:
The highest concentrations analysed in the main study were selected based on the solubility and/or cytotoxicity of the test substance in the cell culture medium. Three dose-finding studies were performed:

[Dose-finding study]
-S9 mix: 8.19, 20.5, 51.2, 128, 320, 800, 2000, 5000 μg/plate (all strains)
+S9 mix: 8.19, 20.5, 51.2, 128, 320, 800, 2000, 5000 μg/plate (all strains)
[Dose-finding restudy]
-S9 mix: 8.19, 20.5, 51.2, 128, 320, 800, 2000, 5000 μg/plate (all strains)
+S9 mix: 8.19, 20.5, 51.2, 128, 320, 800, 2000, 5000 μg/plate (all strains)
[Dose-finding additional study]
-S9 mix
6.25, 12.5, 25.0, 50.0, 100, 200 μg/plate (TA100),
3.13, 6.25, 12.5, 25.0, 50.0, 100 μg/plate (TA98),
0.0977, 0.195, 0.391, 0.781, 1.56, 3.13, 6.25, 12.5 μg/plate (TA1537)
+S9 mix:
6.25, 12.5, 25.0, 50.0, 100, 200 μg/plate (TA1537)

ADDITIONAL INFORMATION ON CYTOTOXICITY:
The test substance was not cytotoxic to tester strains TA1535 and WP2uvrA at any concentration with and without metabolic activation.
In the dose-finding studies and in the main study, the minimum cytotoxic concentrations determined for the tester strains TA100, TA98 and TA1537 were as follows:

[Dose-finding study]
-S9 mix: 8.19 (TA1537) and 128 (TA100) μg/plate
+S9 mix: 128 (TA1537) and 320 (TA100) μg/plate
[Dose-finding restudy]
-S9 mix: 8.19 (TA1537), 51.2 (TA98) and 128 (TA100) μg/plate
+S9 mix: 128 (TA1537), 320 (TA100) μg/plate
[Dose-finding additional study]
-S9 mix: 3.13 (TA1537) and 100 (TA100, TA98) μg/plate
+S9 mix: 200 (TA1537) μg/plate
[Main study]
-S9 mix: 4.88 (TA1537), 78.1 (TA98) and 156 (TA100) µg/plate
+S9 mix: 156 (TA100) and 313 (TA1537) µg/plate
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Table 1. Results of the bacterial reverse mutation test

With or without S9-Mix

Test substance concentration

(μg/plate)

Mean number of revertant colonies per plate

(average of 3 plates ± standard deviation)

Base-pair substitution type

Frameshift type

TA 100

TA1535

WP2urvA

TA98

TA1537

0

129 ± 7

13 ± 2

25 ± 5

21 ± 2

9 ± 1

0.153

 

 

 

 

9 ± 2

0.305

 

 

 

 

7 ± 1

0.610

 

 

 

 

9 ± 1

1.22

 

 

 

 

12 ± 1

2.44

 

 

 

 

7 ± 2

4.88

129 ± 5

 

 

21 ± 1

10 ± 2*

9.77

139 ± 4

 

 

18 ± 3

10 ± 3*

19.5

125 ± 5

 

 

20 ± 4

 

39.1

134 ± 3

 

 

17 ± 2

 

78.1

142 ± 6

 

 

18 ± 3*

 

156

131 ± 6 *

12 ± 2

16 ± 3

24 ± 6*

 

313

10 ± 3

22 ± 3

 

 

625

12 ± 2

21 ± 4

 

 

1250 (+)

10 ± 2

16 ± 2

 

 

2500 (+)

10 ± 2

16 ± 2

 

 

5000 (+)

 

9 ± 1

13 ± 3

 

 

Positive controls,

–S9

Name

AF2

SA

AF2

AF2

9AA

Concentrations

(μg/plate)

0.01

0.5

0.01

0.1

80

Mean No. of colonies/plate

(average of 3 plates ± SD)

886 ± 5

549 ± 8

148 ± 19

689 ± 53

200 ±7

+

0

121 ± 4

13 ± 1

26 ± 5

29 ± 1

25 ± 3

+

9.77

132 ± 7

 

 

 

20 ± 2

+

19.5

130 ± 6

 

 

 

20 ± 2

+

39.1

125 ± 8

 

 

 

21 ± 2

+

78.1

121 ± 4

 

 

 

13 ± 4

+

156

123 ± 4*

14 ± 0

25 ± 4

24 ± 3

12 ± 2

+

313

118 ± 5*

12 ± 2

19 ± 5

25 ± 3

10 ± 2*

+

625 (+)

106 ± 8*

13 ± 2

23 ± 4

26 ± 6

 

+

1250 (+)

 

8 ± 2

16 ± 2

19 ± 3

 

+

2500 (+)

 

9 ± 1

16 ± 2

19 ± 1

 

+

5000 (+)

 

11 ± 1

16 ± 2

12 ± 2

 

Positive controls, +S9

Name

2AA

2AA

2AA

2AA

2AA

Concentrations

(μg/plate)

1

2

10

0.5

2

Mean No. of colonies/plate

(average of 3 plates ± SD)

1018 ± 35

336 ± 19

732 ± 65

370 ± 10

142 ± 5

(+): Visible precipitation was observed at the end of exposure period.

*: Growth inhibition was observed

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative