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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
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
no S. typhimurium TA102 or E. coli strain was included
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Fatty acids, C16-18, esters with ethylene glycol
EC Number:
292-932-1
EC Name:
Fatty acids, C16-18, esters with ethylene glycol
Cas Number:
91031-31-1
Molecular formula:
C18H36O3, C20H40O3, C34H66O2, C36H70O4, C38H74O2

Method

Target gene:
his operon
Species / strain
Species / strain / cell type:
S. typhimurium, other: TA98, TA100, TA1535, TA1537 and TA1538
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 and 5000 µg/plate with and without metabolic activation
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: Tween 80; 1:1 (w/w); dilution to desired test concentrations with water
Controlsopen allclose all
Untreated negative controls:
yes
Remarks:
untreated suspension
Negative solvent / vehicle controls:
yes
Remarks:
Tween 80/bidist. water
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
Untreated negative controls:
yes
Remarks:
untreatred suspension
Negative solvent / vehicle controls:
yes
Remarks:
Tween 80/bidist. water
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: with S9: 2-aminoanthracene (2.5 µg/plate) for TA1535 and TA1537; (5 µg/plate) for TA98, TA100 and TA1538
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 48 h

NUMBER OF REPLICATIONS: 3 replications each in 2 independent experiments

DETERMINATION OF CYTOTOXICITY
- Method: relative total growth

Evaluation criteria:
A combination of the following criteria was considered as a positive result: the plate background of non-reverted bacteria did not show any growth reduction versus the respective negative controls; the spontaneous mutation rates of each tester strain per plate were within the characteristic spontaneous mutation range; as a rule, the positive controls showed mutation rates exceeding the control values of TA 100 at least by the factor 2.0 and those of the other tester strains at least by the factor 3.03; at more than one dose tested, the test substance caused at least a 2.0-fold increase in comparison with the negative controls in the tester strain TA 100. For the other tester strains, an increase in the mutation rate of more than 3.0 above the corresponding negative controls was considered positive.

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535
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
True negative controls validity:
not examined
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1537
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
True negative controls validity:
not examined
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 98
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
True negative controls validity:
not examined
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 100
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
True negative controls validity:
not examined
Positive controls validity:
valid
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:
not examined
True negative controls validity:
not examined
Positive controls validity:
valid
Additional information on results:
TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: noted at concentrations of 5000 µg/plate

Any other information on results incl. tables

Table 1: Maximum revertants of both experimental series

 

Maximum number of revertants (dose level in µg/mL)

solvent control

positive control

test substance

Strain

With S9

Without S9

With S9

Without S9

With S9

Without S9

TA 98

45.0

25

1218

643

46.7 (1000)

24.3 (1000)

TA 100

132.7

111

936.7

318.0

122.3 (1000)

115.0 (1000)

TA 1535

19.0

12.3

274.0

384.0

15.0 (1000)

13.0

(200)

TA 1537

11.3

9.3

124.7

955.3

13.3

(200)

11.3 (1000)

TA 1538

18.7

9.0

1499.7

1678.0

24.3

(200)

10.7

(40)

Applicant's summary and conclusion

Conclusions:
Interpretation of results: negative