Distilled acetalization product between glucose and C12-18(even numbered)alcohol

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Three different in vitro tests (OECD 471 473 476) were performed and were negatives for the whole category. Some of them are available on different members of the category. The conclusion on gene mutation is therefore “Not classified - based on specific, valid data on the category”. Based on the negatives clastogenicity assays, the conclusion on clastogenicity is “Not classified - based on specific, valid data on the category”. Considering REACH Annex IX 8.4 criteria, an in vivo genotoxicity study does not need to be proposed as there were no positive results in vitro.

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:

from 2010-05-17 to 2010-06-02

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD guideline, GLP compliance

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

2010-07-19

Type of assay:

bacterial reverse mutation assay

Target gene:

S. typhimurium: histidine
E. coli: tryptophane

Species / strain / cell type:

E. coli WP2

Additional strain / cell type characteristics:

other: uvrA-; pKM101

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Metabolic activation system:

Sp-mix

Test concentrations with justification for top dose:

bacteriostatic assay: maximum 5000ug/Plate tested.
other assay: maximum 1500 mg/plate. (12 / 45 / 150 / 450 / 1500 ug/plate)

Vehicle / solvent:

Ethanol

Positive controls:

yes

Positive control substance:

other: dimethylbenzanthracene

Positive controls:

yes

Positive control substance:

other: cis-Platinum

Positive controls:

yes

Positive control substance:

2-nitrofluorene

Positive controls:

yes

Positive control substance:

9-aminoacridine

Positive controls:

yes

Positive control substance:

other: 2-anthramine

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

Ethanol

Positive controls:

yes

Positive control substance:

sodium azide

Details on test system and experimental conditions:

Assay mithout metabolic activation
Salmonella typhimurium strains: for every strain, 0.1mL of the bacterial suspension containing 1-5 *10^9 bacteria/mL and 0.1 mL of every yest substance concentration are successively added to two mL of overlay agar maintained surfusion in 45°C containing 10%(v/v) of aL-Histidin-D-Biotin solution (0.5 mM).
Escherichia coli strain: in a test tube 0.1 mL of the bacterial suspension containing 1-5*10^9 and 0.1 mLof every test substance concentration are successively added to 2 mL of overlay agar maintained surfusion in 45°C containing 5% (v/v) of nutrient broth n°2 to which are added 5 uL of a L-Tryptophan solution at 2 mg/mL.
Plates are incubated at 37°C over 48-72 hour period. The number of revertant colonies per plate is counted.

Assay with metabolic activation
Two test can be performed using
- either a standard plate incorporation method where the protocol is similar to that described above, except that just before pouring the mixture onto the plates, 500uL of S9-mix fraction is quickly mixed,
- or the pre-incubation assay where the test substance is preincubated with test strain, and 500uL of S9-mix fraction usually for 20 min, or more at 37°C prior to mixing with the averlay agar and pouring onto the surface of the animal agar plate. Tubezs should be aerated during pre-incubation by using a shaker. This method is known to increase the detection sensivity of a number of promutagens like alkaloïds, aliphatic N-nitroso compounds (OECD n°471)

Evaluation criteria:

R= number of revertant colonies in the presence of the substance/ number of revertant colonies in the absence of the test substance

Species / strain:

E. coli WP2

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

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

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'.

Conclusions:

Interpretation of results (migrated information):
negative

The test substance, LCE 10038 lot n°T93611 (LEMI code: DTT 120510), provided by SEPPIC, does not induce any mutagenic change in Salmonella typhimurium TA 1535, 1537, TA 98, TA 100 and Escherichia coli WP2(uvrA) (pKM101), without or with metabolic activation according to the OECD guidelines n°471 and to the method B13/B14 of the directive 2000/32/EC

Executive summary:

The purpose of this procedure is to quantitatively assess the mutagenic effect of a test substance in four Salmonelle typhimurium strains (Ames and al) and one Escherichia coli WP2 (uvrA-) (pKM 101) strain (Matsuchima and al), in compiance with the OECD guidelines 471 for the testing of chemicals.

The assay is performed using five concentrations of the test substance, in both the presence and absence of an appropriate metabolic activation system (rat liver microsome fraction).

Concentrations tested: 12 / 45 / 150 / 450 / 1500 ug/plate

The test substance, LCE 10038 lot n°T93611 (LEMI code: DTT 120510), provided by SEPPIC, does not induce any mutagenic change in Salmonella typhimurium TA 1535, 1537, TA 98, TA 100 and Escherichia coli WP2(uvrA) (pKM101), without or with metabolic activation according to the OECD guidelines n°471 and to the method B13/B14 of the directive 2000/32/EC

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)