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Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

D-Glucopyranose, oligomeric, C10-16-alkyl glycosides, 2-hydroxy-3-sulfopropyl ethers, sodium salts did not induce chromosome aberration in Chinese hamster lung fibroblast (CHL) cell with or without S9 metabolic activation.

Bacterial mutagencicity also returned a negative result for this substance.

Supporting data for C10 - 16 alkyl polyglucoside, which is considered to be a suitable read-across material, also found negative results. The genotoxic potential of CIO-16 alkyl polyglucoside (APG) was evaluated in an assay for chromosomal aberrations using Chinese hamster V 79 lung fibroblasts, with and without metabolic activation. C10-16 APG was not clastogenic in this assay.

Link to relevant study records

Referenceopen allclose all

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test based in official method OCDE 471 , and performed under GLP
Justification for type of information:
SugaNate 160NC has been used in this end point as a read-across substance for SugaNate 100NC. A comparison of the two substances and a read-across justification can be found in section 13 of this dataset.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
Principles of method if other than guideline:
The purpose of this study was to evaluate if the test material would induce a mutagenic response in four different strains of Salmonella (TA98,TA100, TA1335 and TA 1537 ) and E-coli WP2.
The test involves the analysis of the number of revertant colonies that are obtained with each strain in the presence or absence of the test material. Since mutagenic response could vary with the concentration , test material is dosed over an appropriate concentration range (5). Complete set of possitive and negative controls have been included with each assay.
Testing was done with solvent control
All dose levesls of the test material , solvent control and positive controls were plated in triplicate. (Refer to Protocol M09-0093 included in this dossier for the detailed test procedure)
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay
Target gene:
(Refer to Protocol M09-0093 included in this dossier for the detailed test procedure)
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
E. coli WP2 uvr A
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
S-9 activation
Test concentrations with justification for top dose:
5.0,1.0,0.5,0.1 and 0.05 micrograme /plate
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
Positive controls:
yes
Positive control substance:
other: 2-aminoantraceno (all strains +s9)
Remarks:
See información about material and methods
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:
no 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
Endpoint:
in vitro cytogenicity / chromosome aberration study in mammalian cells
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
SugaNate 160NC has been used in this end point as a read-across substance for SugaNate 100NC. A comparison of the two substances and a read-across justification can be found in section 13 of this dataset.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
GLP compliance:
not specified
Remarks:
Review article did not specify these details
Type of assay:
in vitro mammalian chromosome aberration test
Species / strain / cell type:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
with and without
Metabolic activation system:
at concentrations of <160 microg/mL with and <16 microg/mL without metabolic activation.'
Species / strain:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
not applicable
Untreated negative controls validity:
valid
Positive controls validity:
valid
Conclusions:
The genotoxic potential of CIO-16 alkyl polyglucoside (APG) was evaluated in an assay for chromosomal aberrations using Chinese hamster V 79 lung fibroblasts, with and without metabolic activation. C10-16 APG was not clastogenic in this assay. Positive and negative controls gave expected results.
Endpoint:
in vitro cytogenicity / chromosome aberration study in mammalian cells
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
SugaNate 160NC has been used in this end point as a read-across substance for SugaNate 100NC. A comparison of the two substances and a read-across justification can be found in section 13 of this dataset.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
Version / remarks:
The Guidelines for the Testing of Chemicals: Health Effects Part [M], Second Edition, China Environmental Press, 2013.
OECD Guideline For The Testing Of Chemicals. TG 473 In Vitro Mammalian Chromosome Aberration Test. OECD, 2014
Deviations:
no
GLP compliance:
yes
Type of assay:
in vitro mammalian chromosome aberration test
Specific details on test material used for the study:
Name: D-Glucopyranose, oligomeric, C10-16-alkyl glycosides, 2-hydroxy-3-sulfopropyl ethers, sodium salts
Short name: Sodium Laurylglucosides Hydroxypropylsulfonate
Lot No. : KDM-1021-174
Physical properties: Amber semisolid
Purity: 88.1 %
Valid until: 20 January, 2018
Storage: Room temperature
Manufacturer: Colonial Chemical, Inc.
Species / strain / cell type:
Chinese hamster lung fibroblasts (V79)
Remarks:
Chinese hamster lung fibroblast (CHL) cell.
Details on mammalian cell type (if applicable):
Cells were cultured in 96-well plates in a concentration of 8000 cells/well
Metabolic activation:
with and without
Metabolic activation system:
Cells were exposed to the test substance with S9 metabolic activation for 3 hours, or exposed to the test substance without metabolic activation for 3 h and 24 h.
Test concentrations with justification for top dose:
The solubility of D-Glucopyranose, oligomeric, C10-16-alkyl glycosides, 2-hydroxy-3-sulfopropyl ethers, sodium salts in DMSO was 50 mg/mL. In solubility test, each concentration of the test substance was completely dissolved with 0.5 mg/mL as the highest concentration. So, in our cytotoxicity test, 0.5 mg/mL was used as the highest concentration.
D-Glucopyranose, oligomeric, C10-16-alkyl glycosides, 2-hydroxy-3-sulfopropyl ethers, sodium salts 0.5 mg/mL was used as the highest concentration and other 8 lower concentrations were 0.25 mg/mL, 0.125 mg/mL, 0.0625 mg/mL, 0.03125 mg/mL, 0.01563 mg/mL, 0.00781 mg/mL, 0.00391 mg/mL, 0.00195 mg/mL.
Untreated negative controls:
yes
Remarks:
Name: Dimethyl sulfoxide, Short name: DMSO, Lot No.: SHBG6226V Manufacturer: Sigma-Aldrich
Positive controls:
yes
Positive control substance:
methylmethanesulfonate
Key result
Species / strain:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
Cytotoxicity test showed that IC50 values of test substance were between 0.01563 mg/mL and 0.03125 mg/mL in +S9/3h systems, while it was between 0.007813 mg/mL and 0.01563 mg/mL in -S9/3h systems and -S9/24h systems.
With S9 metabolic activation system, the percentage of aberrant cells in groups treated with D-Glucopyranose, oligomeric, C10-16-alkyl glycosides, 2-hydroxy-3-sulfopropyl ethers, sodium salts were 2.00 %, 2.49 % and 1.49 %, respectively, and the corresponding concentrations were 0.03125 mg/mL, 0.01563 mg/mL and 0.007813 mg/mL. There was no statistical significance compared to vehicle control group (1.50 %).
Without S9 metabolic activation, the percentage of aberrant cells in D-Glucopyranose oligomeric, C10-16-alkyl glycosides, 2-hydroxy-3-sulfopropyl ethers, sodium salts treatment groups for 3h with three concentrations of 0.01563 mg/mL, 0.007813 mg/mL and 0.003906 mg/mL were 1.90 %, 2.44 % and 1.99 %, respectively. There was no statistical significance compared to vehicle control group (1.87 %). Without S9 metabolic activation, the percentage of aberrant cells in D-Glucopyranose, oligomeric, C10-16-alkyl glycosides, 2-hydroxy-3-sulfopropyl ethers, sodium salts treatment groups for 24h with three concentrations of 0.01563 mg/mL, 0.007813 mg/mL and 0.003906 mg/mL were 2.91 %, 1.94 % and 1.50 % respectively. There were no statistical significance compared to vehicle control group (1.99%).
Compared to the vehicle control group, the percentage of aberrant cells in groups treated with positive control Cyclophosphamide (25 μg/mL) in +S9/3h systems was 12.50 % (P<0.001), Methyl Methanesulfonate (0.25 μg/mL) in -S9/3h and -S9/24h were 11.44 % (P<0.001) and 11.50 % (P<0.001).
Conclusions:
D-Glucopyranose, oligomeric, C10-16-alkyl glycosides, 2-hydroxy-3-sulfopropyl ethers, sodium salts (Lot No.: KDM-1021-174) did not induce chromosome aberration in Chinese hamster lung fibroblast (CHL) cell with or without S9 metabolic activation.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Justification for classification or non-classification