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Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information
In vitro bacterial mutation studies are negative for the registation substance and for read-across substances (structural analogues). Studies on mammalian cells are negative for a read-across substances (structural analogue) and for a source substance / constituent) with regard to in vitro testing for gene mutation and clastogenicity. For the source substance / constituent, also genetic toxicity in vivo is negative. General evaluation All experimental studies reported are GLP compliant guideline studies, the key studies have a Klimisch score 1 while the Klimisch scores of the supporting studies were changed from 1 to 2 to reflect the fact that they were conducted on read-across substances. The literature data reported in two cases for a source substance / constituent have a Klimisch score 2 and represent an acceptable, well-documented publication describing experimental results meeting basic scientific principles. Overall, Sucroglyceride C12 -18, C18unsatd. is considered to be not mutagenic and to have no genotoxic potential.
Link to relevant study records
Reference
Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Version / remarks:
1983
Deviations:
no
Principles of method if other than guideline:
Performed as described by Maron DM and Ames BN (Revised methods for the Salmonella mutagenicity test. Mutation Res. 113. 173-215, 1983).
The study was performed equivalent to the OECD guideline 471 of 1983. Therefore, the additional strain S. typhimurium TA 102 or E. coli WP2 was not tested as required by the current guideline.
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay
Target gene:
his
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
other: rfa, uvrB-
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Test concentrations with justification for top dose:
Dose finding preliminary toxicity test:
9.8, 19.5, 39.1, 78.1, 156.3, 312.5, 625.0, 1250, 2500, 5000 µg/plate

Main test
6.4, 32, 160, 800, 4000 µg per plate
Vehicle / solvent:
Methanol/H2O = 1 : 2
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
sodium azide
N-ethyl-N-nitro-N-nitrosoguanidine
other: 9-Aminoacridinehydrochloride monohydrate; 4-nitro-1,2-phenylene diamine
Remarks:
without S9 mix
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene
Remarks:
with S9 mix
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 48 h

SELECTION AGENT (mutation assays): histidine deficient medium

NUMBER OF REPLICATIONS: 4

DETERMINATION OF CYTOTOXICITY
- Method: background growth / number of revertants
Evaluation criteria:
A reproducible and dose related increase of mutant counts for at least one strain is considered to be positive. For TA 100, TA 98 and TA 1535 a twofold increase of revertants compared to the negative controls should be reached, whereas for TA 1537 a threefold increase should be reached. Otherwise the results are estimated as being negative.

The following criteria were used for the acceptance of an assay:
- The negative controls have to be within the expected range as defined by literature data (Maron and Ames 1983).
- The positive controls have to show sufficient effects as defined by the laboratories' experience.
- The titer determination must yield a sufficient bacterial density in the suspension.
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
Vehicle controls validity:
valid
Positive controls validity:
valid
Additional information on results:
RANGE-FINDING/SCREENING STUDIES:
A bacteriotoxic effect was observed in doses ranging from 312.5 µg to 5000 µg per plate. Therefore the following doses were chosen for the main test: 6.4, 32, 160, 800 and 4000 µg/plate. The test substance was diluted in Methanol/H2O 1 : 2.

The evaluation of the individual dose groups with respect to the parameters relevant for assessment (dose effect and doubling), showed no biologically relevant variations from the respective negative controls for all strains.

In the positive controls, the mutant counts increased to more than twice the amount compared to the negative controls. This showed that the system is highly sensitive.
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.
Conclusions:
Interpretation of results (migrated information):
negative

Based on the results of this study it is concluded that test substance is not mutagenic in the Salmonella typhimurium reverse mutation assay (test strains: TA 98, TA 100, TA 1535, TA 1537).
Executive summary:

In a reverse gene mutation assay in bacteria equivalent to OECD Guideline 471 (Bacterial Reverse Mutation), strains TA 1535, TA 1537, TA 98, T 100 of S. typhimurium were exposed to Sucroglyceride C12-18, C18unsatd. in Methanol/H2O = 1 : 2, at concentrations of: 6.4, 32, 160, 800, 4000 µg per plate in the presence and absence of mammalian metabolic activation.

Sucroglyceride C12-18, C18unsatd. was tested up to cytotoxic concentrations. No evidence of a mutagenic activity of the test substance was found. Neither a dose related doubling nor a biologically relevant increase in the mutant count with and without S9 mix in comparison with the negative control (solvent) was observed. The positive controls induced the appropriate responses in the corresponding strains.

 

Based on the results of this study it is concluded that Sucroglyceride C12-18, C18unsatd. is not mutagenic in the Salmonella typhimurium reverse mutation assay.

 

This study is classified as acceptable. It satisfies the requirement for Test Guideline OECD 471 (1983) for in vitro mutagenicity (bacterial reverse gene mutation) data.

The negative result from the first test was confirmed by a second independent experiment. The results of the positive control substances confirm the specifity of the tester strains as well as the full activity of the metabolizing system.

The adopted OECD TG 471 (1997) requires at least 5 test strains and the use of E. coli WP2 strains or Salmonella typhimurium TA 102 to detect certain oxidizing mutagens, cross-linking agents and hydrazines. However, Sucroglyceride C12-18, C18unsatd.

is not a highly reactive agent and is therefore not expected to be a cross-linking agent, has no oxidizing properties and is no hydrazine. Thus, a GLP test according to former versions of the Test Guideline without E. coli WP2 strains or Salmonella typhimurium TA 102 is considered as sufficient to evaluate the mutagenic activity of Sucroglyceride C12-18, C18unsatd. in this bacterial test system.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

In vitro – Ames Test

 

Key study on the registration substance Sucroglyceride C12-18, C18unsatd. (Evonik, 1990)

The purpose of the study was to investigate the potential of the test substance Sucroglyceride C12-18, C18unsatd. to induce mutations using the bacterial reverse mutation assay.

The study was conducted in accordance with the OECD guideline 471 (Bacterial reverse mutation test) in the version dated 1983. The assay was performed in two independent experiments. Both took place as a plate incorporation test, using the S. typhimurium strains TA 1535, TA 1537, TA 98, TA 100. All experiments were in the absence and in the presence of mammalian metabolic activation by a rat liver post mitochondrial fraction (S9). The number of replications was 4.

The current version of the OECD guideline 471 (adopted in 1997) requires at least 5 test strains and the use of E. coli WP2 strains or S. typhimurium TA 102 to detect certain oxidizing mutagens, cross-linking agents and hydrazines. However, the test substance Sucroglyceride C12-18, C18unsatd. is not a highly reactive agent and is therefore not expected to be a cross-linking agent, has no oxidizing properties and is no hydrazine. Thus, a GLP test according to former versions of the method without E. coli WP2 strains or S. typhimurium TA 102 is considered sufficient to evaluate the mutagenic activity of Sucroglyceride C12-18, C18unsatd. in this bacterial test system.

 

The four tester strains of S. typhimurium were exposed to Sucroglyceride C12-18, C18unsatd. in Methanol/H2O = 1 : 2. Five concentrations were tested: 6.4-32-160-800-4000 μg per plate in the presence and absence of metabolic activation.

Sucroglyceride C12-18, C18unsatd. was tested up to cytotoxic concentrations. No evidence of a mutagenic activity of the test substance was found. Neither a dose related doubling nor a biologically relevant increase in the mutant count with and without S9 mix in comparison with the negative control (solvent) was observed. The positive controls induced the appropriate responses in the corresponding strains.

The negative result from the first test was confirmed by a second independent experiment. The results of the positive control substances confirm the specificity of the tester strains as well as the full activity of the metabolising system.

Based on the results of this study it is concluded that Sucroglyceride C12-18, C18unsatd. is not mutagenic in the Salmonella typhimurium reverse mutation assay.

 

Supporting study on the read-across substance Sucroglyceride C12 (Evonik, 1990)

The purpose of the study was to investigate the potential of the read-across substance Sucroglyceride C12, a structural analogue of the registration substance, to induce mutations using the bacterial reverse mutation assay.

The study design was identical to the key study reported above.

The four tester strains of S. typhimurium were exposed to Sucroglyceride C12 in Methanol/H2O = 1 : 2. 0.1 mL each of five concentrations were tested: 1.6-8-40-200-1000 μg per plate in the presence and absence of metabolic activation.

Sucroglyceride C12 was tested up to cytotoxic concentrations. No evidence of a mutagenic activity of the test substance was found. Neither a dose related doubling nor a biologically relevant increase in the mutant count with and without S9 mix in comparison with the negative control (solvent) was observed. The positive controls induced the appropriate responses in the corresponding strains.

The negative result from the first test was confirmed by a second independent experiment. The results of the positive control substances confirm the specificity of the tester strains as well as the full activity of the metabolizing system.

Based on the results of this study it is concluded that Sucroglyceride C12 is not mutagenic in the Salmonella typhimurium reverse mutation assay.

 

Supporting study on the read-across substance Stearic acid, esters with methyl α-D-glucoside (Evonik, 1990)

The purpose of the study was to investigate the potential of the read-across substance Stearic acid, esters with methyl α-D-glucoside, a structural analogue of the registration substance, to induce mutations using the bacterial reverse mutation assay. The test substance is solid. Purity is 100%.

The study design was identical to the key study reported above.

The four tester strains of S. typhimurium were exposed to Stearic acid, esters with methyl α-D-glucoside in DMSO. 0.1 mL each of five concentrations were tested: 8-40-200-1000-5000 μg per plate in the presence and absence of metabolic activation. The maximum concentration in the main experiments was set at 5000 μg per plate since in the preliminary screening no certain cytotoxicity was observed up to this concentration.

 

Stearic acid, esters with methyl α-D-glucoside did not induce a significant dose-related increase in the number of revertant colonies in all four tested strains, both in the absence and presence of mammalian metabolic activation. These results were confirmed in an independently repeated experiment. No cytotoxic effects of the test substance were observed. Precipitation was observed at concentrations of 5000 µg/plate.

The positive controls induced the appropriate responses in the corresponding strains and metabolic activation was confirmed. 

There was no evidence of induced mutant colonies over background.Based on these results it is concluded that Stearic acid, esters with methyl α-D-glucoside is not mutagenic in the Salmonella typhimurium reverse mutation assay.

Supporting study on the read-across substance Isostearic acid, esters with methyl α-D-glucoside (Evonik, 2008)

The purpose of the study was to investigate the potential of the read-across substance Isostearic acid, esters with methyl α-D-glucoside, a structural analogue of the registration substance, to induce mutations using the bacterial reverse mutation assay. The test substance is a yellow paste. Purity is 100%.

The study was conducted in accordance with the OECD guideline 471 (Bacterial reverse mutation test) in the current version dated 1997.

Strains of S. typhimurium (TA 1535, TA 1537, TA 98 and TA 100) and of E. coli (WP2 uvr A) were exposed to Isostearic acid, esters with methyl α-D-glucoside, in DMSO at concentrations of 33, 100, 333, 1000 and 3330 µg/plate in the presence and absence of mammalian metabolic activation (plate incorporation method). Isostearic acid, esters with methyl α-D-glucoside did not induce a significant dose-related increase in the number of revertant colonies in each of the five tester strains, both in the absence and presence of mammalian metabolic activation. These results were confirmed in an independently repeated experiment. No cytotoxic effects of the test substance were observed. Precipitation was observed at concentrations of 1000 and 3330 µg/plate. The positive controls induced the appropriate responses in the corresponding strains and metabolic activation was confirmed.

There was no evidence of induced mutant colonies over background. Based on these results it is concluded that Isostearic acid, esters with methyl α-D-glucoside is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.

 

 

In vitro – Clastogenicity

 

Supporting study on the read-across substance Isostearic acid, esters with methyl α-D-glucoside (Evonik, 2008)

The purpose of the study was to investigate the potential of the read-across substance Isostearic acid, esters with methyl α-D-glucoside, a structural analogue of the registration substance, to induce chromosome aberrations with mammalian cells in vitro. The test substance is a yellow paste. Purity is 100%.

The study was conducted in accordance with the OECD guideline 473 (In VitroMammalian Chromosome Aberration Test).

In a mammalian cell cytogenetics assay, peripheral human lymphocyte cultures were exposed to Isostearic acid, esters with methyl α-D-glucoside in DMSO at concentrations of 0, 33, 100, 333 µg/mL culture medium (3 h exposure time , 24 h fixation time with and without metabolic activation in the first cytogenetic assay. In the second cytotgenetic assay concentrations of 0, 100, 300, 400, 500, 600, 700, 800 µg/mL (24 h and 48 h exposure time and fixation time) without S9-mix and 0, 33, 100, 300 µg/mL (3 h exposure time, 48 h fixation time) with S9-mix were tested, respectively.

Isostearic acid, esters with methyl α-D-glucoside was tested up to cytotoxic and precipitating concentration. In the first cytogenetic assay, the test substance was tested up to 333 µg/mL for a 3 h exposure time with a 24 h fixation time in the absence and presence of 1.8% (v/v) S9-fraction. Isostearic acid, esters with methyl α-D-glucoside precipitated in the culture medium at this dose level. In the second cytogenetic assay, Isostearic acid, esters with methyl α-D-glucoside was tested up to 800 µg/mL for a 24 h and 48 h continuous exposure time with a 24 h and 48 h fixation time in the absence of S9-mix. Appropriate toxicity was reached at 600 µg/mL. In the presence of S9-mix Isostearic acid, esters with methyl α-D-glucoside was tested up to 300 µg/mL for a 3 h exposure time with a 48 h fixation time. The test substance precipitated in the culture medium at this dose level.

Isostearic acid, esters with methyl α-D-glucoside did not induce a statistically significant or biologically relevant increase in the number of cells with chromosome aberrations in the absence and presence of S9-mix, in either of the two independently repeated experiments.

No biologically relevant effects of Isostearic acid, esters with methyl α-D-glucoside on the number of polyploid cells and cells with endo-reduplicated chromosomes were observed both in the absence and presence of S9-mix. Therefore it can be concluded that the test substance does not disturb mitotic processes and cell cycle progression and does not induce numerical chromosome aberrations under the experimental conditions described.

Positive controls induced the appropriate response. There was no evidence of chromosome aberration induced over background. The number of cells with chromosome aberrations found in the solvent control cultures was within the laboratory historical control data range.

It is concluded that this test is valid and that Isostearic acid, esters with methyl α-D-glucoside is not clastogenic in human Iymphocytes.

 

Supporting study on the source substance and constituent Mono-Di-Glycerides (Hayes, 1994)

Relevant literature describes the potential of source substances and constituents belonging to the group of Mono-Di Glycerides to induce chromosome aberrations with mammalian cells in vitro.

Results were obtained with substances belonging to the SALATRIM family of triacylglycerols. They differ from other fats in the ratio of short-chain fatty acids (SCFA) to long-chain fatty acids (LCFA) and in that stearic acid is the major LCFA.

SALATRIM 23CA Lot A014, a typical SALATRIM fat, was tested in in vitro mammalian cell genotoxicity assays including the chromosomal aberration. Corn oil also was tested as a reference fat. Both the SALATRIM fat and corn oil were negative in the chromosome aberration assay.

The percent cells with abnormal chromosomes was analyzed statistically and did not differ from the solvent control with either fat tested. The doses used in the presence of metabolic activation were identical to those used in the absence of metabolic activation. The positive controls (methylmethanesulfonate (-S9) and cyclophosphamide (+S9) produced the expected response. There was no change in the mitotic index with either fat compared to the solvent control. Neither fat produced increases in the percent cells with abnormal chromosomes or in any of the other criteria for chromosomal damage.

Therefore, both SALATRIM 23CA lot A014 and corn oil were neither clastogenic nor cytotoxic in the chromosomal aberration assay in the presence or absence of metabolic activation.

 

In vitro – Gene Mutation

 

Supporting study on the read-across substance Isostearic acid, esters with methyl α-D-glucoside (Evonik, 2009)

The purpose of the study was to investigate the potential of the read-across substance Isostearic acid, esters with methyl α-D-glucoside, a structural analogue of the registration substance, to induce gene mutations with mammalian cells in vitro. The test substance is a yellow paste. Purity is 100%.

The study was conducted in accordance with the OECD guideline 476 (In Vitro Mammalian Cell Gene Mutation Test).

 

In a mammalian cell gene mutation assay, mouse lymphoma L5178Y cells cultured in vitro were exposed to Isostearic acid, esters with methyl α-D-glucoside in DMSO. The test was performed in two independent experiments in the absence and presence of S9-mix.

Experiment 1: 0 , 1, 3, 10, 33, 100, 150, 180, 200, 220, 240, 280, 300 µg/mL in absence of mammalian metabolic activation and 0, 1, 3, 10, 33, 100, 200, 250, 300, 350, 400, 425, 500 µg/mL with 8% metabolic activation.

Experiment 2: 0, 10, 25, 33, 50, 100, 115, 150, 175, 180, 200, 210, 220, 240, 260 µg/mL without metabolic activation and 0 , 1, 3, 10, 33, 100, 200, 250, 300, 350, 375 µg/mL with 12% metabolic activation.

Isostearic acid, esters with methyl α-D-glucoside was tested beyond the limit of the solubility to obtain adequate mutagenicity data.

In the first segment of experiment 2, Isostearic acid, esters with methyl α-D-glucoside was tested up to concentrations of 240 µg/mL in the absence of S9-mix and up to concentrations of 350 µg/mL in presence of 8% S9-mix with an incubation time of 3 hours. Isostearic acid, esters with methyl α-D-glucoside was tested up to cytotoxic levels of 12 and 14% in the absence and presence of S9-mix, respectively.

In the second segment of experiment 2, Isostearic acid, esters with methyl α-D-glucoside was tested up to concentrations of 210 µg/mL in the absence of S9-mix and up to concentrations of 375 µg/mL in the presence of 12% S9-mix. The incubation times were 24 hours and 3 hours for incubations in the absence and presence of S9-mix, respectively. Isostearic acid, esters with methyl α-D-glucoside was tested up to cytotoxic levels of 19 and 4% in the absence and presence of S9-mix, respectively.

In the absence of S9-mix, the test substance did not induce a significant increase in the mutation frequency in the first experiment. This result was confirmed in an independent repeat experiment with modifications in the duration of treatment time.

In the presence of S9-mix, the test substance did not induce a significant increase in the mutation frequency in the first experiment. This result was confirmed in an independent repeat experiment with modifications in the concentration of the S9-mix for metabolic activation.

The positive controls did induce the appropriate response. The spontaneous mutation frequencies in the solvent-treated control cultures were between the minimum and maximum value of the historical control data range.

Isostearic acid, esters with methyl α-D-glucoside is not mutagenic in the mouse lymphoma L5178Y test system under the experimental conditions described.

 

Supporting study on the source substance and constituent Mono-Di-Glycerides (Hayes, 1994)

Relevant literature describes the potential of source substances and constituents belonging to the group of Mono-Di Glycerides to induce gene mutations with mammalian cells in vitro.

Results were obtained with substances belonging to the SALATRIM family of triacylglycerols. They differ from other fats in the ratio of short-chain fatty acids (SCFA) to long-chain fatty acids (LCFA) and in that stearic acid is the major LCFA.

SALATRIM 23CA Lot A014, a typical SALATRIM fat, was tested in in vitro mammalian cell genotoxicity assays including the HPRT mammalian cell mutagenesis assay. Corn oil also was tested as a reference fat. Both the SALATRIM fat and corn oil were negative in the HPRT assay.

Positive controls gave the expected results, validating the assay.

Corn oil did not alter either the relative cloning efficiency or the mutation frequency of the cells.

SALATRIM 23CA lot A014 presented no evidence of mutagenic potential under the conditions of the assay.

Therefore, both SALATRIM 23CA lot A014 and corn oil did not induce gene mutations in the HPRT assay in the presence or absence of metabolic activation.

 

In vivo – Chromosome Aberrations

 

Supporting study on the source substance and constituent Mono-Di-Glycerides (Hayes, 1994)

Relevant literature describes the potential of source substances and constituents belonging to the group of Mono-Di Glycerides to induce chromosome aberrations with mammalian cells in vivo.

Results were obtained with substances belonging to the SALATRIM family of triacylglycerols. They differ from other fats in the ratio of short-chain fatty acids (SCFA) to long-chain fatty acids (LCFA) and in that stearic acid is the major LCFA.

SALATRIM 23CA Lot A014, a typical SALATRIM fat, was tested in mammalian cells in vivo in a rat bone marrow micronucleus assay. Corn oil also was tested as a reference fat.

Rats received these SALATRIM fats or corn oil at 10% (w/w) in the diet for 13 weeks. The in-life and bone marrow smear preparation portions of the study were part of a 13-week subchronic toxicity study conducted at Hazleton Wisconsin, Inc., Madison, WI, and the micronucleus assay portion of the study was conducted at Hazleton Washington, Vienna, VA. Detailed information on the experimental design and methods for the subchronic study can be found in the paper for the subchronic toxicology portion of that study (Hayes et al., 1994).

Both the SALATRIM fat and corn oil were negative in the in vivo micronucleus assay. The data confirm that SALATRIM fats lack genotoxic potential.

 

General evaluation of genetic toxicity

Sucroglyceride C12-18, C18unsatd. is negative in an in vitro bacterial reverse mutation assay. Further to the registration substance Sucroglyceride C12-18, C18unsatd. itself, also the three read-across substances, Sucroglyceride C12, Stearic acid, esters with methyl α-D-glucoside and Isostearic acid, esters with methyl α-D-glucoside are negative in the Ames Test. This comparable profile in the bacterial test is taken as experimental evidence in support of the read-across approach applied to other test systems for genetic toxicity.

 

The read-across substance Isostearic acid, esters with methyl α-D-glucoside, comparable to the registration substance Sucroglyceride C12-18, C18unsatd. with regard to the Ames Test, has been examined for its potential clastogenicity and results negative in a chromosome aberration assay in peripheral human lymphocytes.  

Also results reported for Mono-Di-Glycerides, source substances and constituents of the registration substance Sucroglyceride C12-18, C18unsatd., show the absence of a mutagenic potential in tests for chromosome aberrations in vitro.

 

The same read-across substance, Isostearic acid, esters with methyl α-D-glucoside, has also been examined for its potential to cause gene mutations and results negative in a gene mutation assay in mouse lymphoma L5178Y cells.  

Results from gene mutation studies reported for Mono-Di-Glycerides, source substances and constituents of the registration substance Sucroglyceride C12-18, C18unsatd., show the absence of a mutagenic potential in the HPRT mammalian cell mutagenesis assay.

 

Finally, the same Mono-Di-Glycerides, source substances and constituents of the registration substance Sucroglyceride C12-18, C18unsatd., were shown not to be mutagenic, i.e. not to induce chromosome aberrations, in an in vivo rat bone marrow micronucleus test.

 

Based on the experimental evidence provided for Sucroglyceride C12-18, C18unsatd. itself and extrapolating the read-across results for genetic toxicity to the registration substance, Sucroglyceride C12-18, C18unsatd. is considered not to be a mutagen. The substance does not need to be classified for genetic toxicity according to CLP, EU GHS (Regulation (EC) No 1272/2008) and according to DSD (Directive 67/548/EEC) and labelling is not required.


Justification for selection of genetic toxicity endpoint
Only one in vitro study is available on the registration substance.

Justification for classification or non-classification

Sucroglyceride C12-18, C18unsatd. is not mutagenic in the Salmonella typhimurium reverse mutation assay. A read-across substance and source substances / constituents are negative for clastogenicity in in vitro chromosome aberration tests and for gene mutation the mammalian cell gene mutation assay using mouse lymphoma L5178Y cells or in the HPRT test, respectively. In an in vivo micronucleus test, source substances / constituents proved not to be mutagens.

In conclusion, the full set of genotoxicity tests required by the REACH regulation is negative. According to CLP, EU GHS (Regulation (EC) No 1272/2008) and according to DSD (Directive 67/548/EEC), no classification for mutagenic toxicity is necessary for Sucroglyceride C12-18, C18unsatd. and no labelling is required.