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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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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:
09 Apr - 24 Apr 2010
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study with acceptable restrictions. Due to growth inhibition in Salmonella, but not in E.coli strains, only low test concentrations used.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
low test substance concentrations in Salmonella strains used, cytotoxic effects (growth inhibition) not further specified
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
Glycerides, C8-18 and C18-unsatd. mono- and di-, acetates
EC Number:
293-170-2
EC Name:
Glycerides, C8-18 and C18-unsatd. mono- and di-, acetates
Cas Number:
91052-13-0
IUPAC Name:
91052-13-0
Details on test material:
- Name of test material (as cited in study report): Acetic and fatty acid esters of glycerol
- CAS No. of test material (as cited in study report): 91052-13-0
- Molecular weight: 358.47
- Substance type: light yellow, clear liquid
- Physical state: liquid
- Analytical purity: 100%
- Lot/batch No.: K010722
- Stability under test conditions: stable
- Storage condition of test material: room temperature
- Other information (as cited in study report): melting Point: -7.2°C, solubility- Water: insoluble, DMSO: insoluble, Acetone: 100 mg/ mL and more

Method

Target gene:
his operon
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 (PB) and 5,6-benzoflavone (BF)
Test concentrations with justification for top dose:
0.61, 1.2, 2.4, 4.9, 10, 20, 39, and 78 µg/plate without metablic activation: TA 100, TA1535, TA98 and TA1537
10, 20, 39, 78, 156, and 313 µg/plate with metabolic activation: TA 100, TA1535, TA98 and TA1537
313, 625, 1250, 2500, and 5000 µg/plate with and without metabolic activation: E. coli WP2 uvr A
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: acetone
- Justification for choice of solvent/vehicle: Based on the information from the sponsor that the test substance was insoluble in water, a solubility test was performed with DMSO and acetone. The test substance was insoluble at 50 mg/mL in DMSO, and was dissolved at 100 mg/mL in acetone, and neither exothermic reaction nor generation of gas was observed. Therefore acetone was used as solvent for preparation.
Controlsopen allclose all
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: +S9: Benzo(a)pyrene (5.0 µg/plate for TA100, TA98 and TA1537); 2-Aminoanthracene (2.0 and 10.0 µg/plate for TA1535 and WP2 uvrA)
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: -S9: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide (0.01 and 0.1 µg/plate for TA100, WP2 uvrA and TA98, respectively); 2-Methoxy-6-chloro-9-(3-(2-chloroethyl)aminopropylamino)acridine.2HCl (1.0 µg/plate for TA1537); sodium azide (0.5 µg/plate for TA1535)
Details on test system and experimental conditions:
METHOD OF APPLICATION: in medium; in agar (plate incorporation);

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

NUMBER OF REPLICATIONS: Two replications each in 3 independent experiments.

DETERMINATION OF CYTOTOXICITY
- Method: growth inhibition




Evaluation criteria:
If the number of revertant colonies on the test plates increased significantly in comparison with that on the control plates ( based on twice as many as that of the negative control), and dose-response and reproducibility were also observed, the test substance was to be judged postive.
Statistics:
The results at each concentration were demonstrated with the mean and the standard deviation.

Results and discussion

Test resultsopen allclose all
Species / strain:
E. coli WP2 uvr A
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:
not examined
Positive controls validity:
valid
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:
Growth inhibition of the tested bacterium by the test substance was observed at concentrations of 10 µg/plate and above in the absence of metabolic activation as well as at concentrations of 156 µg/plate and above in the presence of metabolic activation.
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Additional information on results:
TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: insoluble
- Precipitation:Yes, at 1250 µg/plate without metabolic activation and at 5000 µg/plate with metabolic activation.

RANGE-FINDING/SCREENING STUDIES:
In the preliminary test, the growth inhibition by the test substance was observed at 20 µg/plate and in S. typhimurim TA98, TA1537 without metabolic activation, and at 78 µg/plate and in S. typhimurim TA100, TA1535 without metabolic activation, and at 313 µg/plate and in S. typhimurim TA strains with metabolic activation. Therefore, as the highest dose level of the test substance in the main tests, the 20 µg/plate dose was selected for S. typhimurim TA98, TA1537 without metabolic activation, and the 78 µg/ plate was selected for S. typhimurim TA100, TA1535 without metabolic activation, and the 313 µg/plate dose was selected for S. typhimurim TA strains with metabolic activation, and these highest dose was diluted 5 times (using a ratio of 2) to provide a total of 6 dose levels. And the 5000 µg/plate dose was selected for E.coli WP2uvrA both with and without metabolic activation, and this highest dose was diluted 4 times (using a common ratio of 2) to provide a total of 5 dose levels.

Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

1st experiment

number of revertants: mean value of negative control

number of revertants: mean value of positive control

max. number of revertants: mean value of test material [µg/plate]

                without S9-mix

 

 

 

TA 1535

14 ±2

399 ±25

 12±2.5 [39]

TA 100

103±5.0

825 ± 34.6

113 ± 9.7 [4.9]

TA 1537

11±1.5

 1989± 52.0

 13±0.6 [10]

TA 98

19 ±1.7

561 ± 19

18 ±4.4 [1.2]

WP2uvrA

25 ±4.0

243 ±24.7

30 ±2.6 [5000]

with S9-mix

 

 

 

TA 1535

 11± 0.6

399 ±25

12 ±2.5 [20]

TA 100

111 ± 6.1

825 ± 34.6

126 ±7.5 [39]

TA 1537

17 ±4.7

 1989± 52.0

 20±3.8 [20]

TA 98

29±1.5

561 ± 19

28 ±5.0 [39]

WP2uvrA

28 ±0.6

243 ±24.7

 33±7.0 [5000]

2nd experiment

number of revertants: mean value of negative control

number of revertants: mean value of positive control

max. number of revertants: mean value of test material [µg/plate]

          without S9-mix

 

 

 

TA 1535

 10±2.3

 388± 16.4

8 ±0.6 [10]

TA 100

121 ± 6.0

780 ±7.1

114 ±7.8 [20]

TA 1537

11 ±1.0

 2057±200.9

15 ±0 [4.9]

TA 98

17 ±1.2

577 ±32.8

20±1.5  [1.2]

WP2uvrA

20 ±2.0

219 ±28:1

27 ±4.6 [1250]

with S9-mix

 

 

 

TA 1535

9 ±2.1

388 ±16.4

11 ±3.2 [78]

TA 100

114 ±12.7

780 ±7.1

 117±9.3 [10]

TA 1537

23 ±4.7

2057 ±200:9

 21±2.3 [10]

TA 98

25±3.8

577 ±32.8

29 ±2.6 [39]

WP2uvrA

 25± 3.2

219 ±28:1

35 ±2.1 [1250]

 

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative