D-pentose and D-glucose, oligomeric, C12 and C14 alkyl glycosides

Genetic toxicity: in vitro

Administrative data

Endpoint:

genetic toxicity in vitro

Remarks:

Type of genotoxicity: gene mutation

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Category is coherent for more than 10 endpoints. Non mutagenic category approach is based on clearly negative Ames test for APP-6505 and APP-6669.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Materials and methods

Principles of method if other than guideline:

Guidance on information requirements and chemical safety assessment - Chapter R.6: QSARs and grouping of chemicals - ECHA, May 2008.

GLP compliance:

no

Remarks:

Not relevant for category approach.

Type of assay:

other: Category approach based on OECD-471 studies.

Test material

Test material information

Constituent 1

Reference substance name:

D-xylofuranose oligomeric dodecyl glycosides (degree of polymerisation = 1)

Molecular formula:

C15H30O5

IUPAC Name:

D-xylofuranose oligomeric dodecyl glycosides (degree of polymerisation = 1)

Constituent 2

Reference substance name:

D-xylofuranose oligomeric dodecyl glycosides, degree of polymerisation 2

Molecular formula:

C20H38O9

IUPAC Name:

D-xylofuranose oligomeric dodecyl glycosides, degree of polymerisation 2

Constituent 3

Reference substance name:

D-xylofuranose oligomeric tetradecyl glycosides (degree of polymerisation = 1)

Molecular formula:

C17H34O5

IUPAC Name:

D-xylofuranose oligomeric tetradecyl glycosides (degree of polymerisation = 1)

Constituent 4

Reference substance name:

D-xylofuranose oligomeric tetradecyl glycosides, degree of polymerisation 2

Molecular formula:

C20H38O9

IUPAC Name:

D-xylofuranose oligomeric tetradecyl glycosides, degree of polymerisation 2

Constituent 5

Reference substance name:

D-glucopyranose oligomeric dodecyl glycosides, degree of polymerisation 1

Molecular formula:

C15H30O5

IUPAC Name:

D-glucopyranose oligomeric dodecyl glycosides, degree of polymerisation 1

Constituent 6

Reference substance name:

D-glucopyranose oligomeric dodecyl glycosides, degree of polymerisation 2

Molecular formula:

C20H39O9

IUPAC Name:

D-glucopyranose oligomeric dodecyl glycosides, degree of polymerisation 2

Constituent 7

Reference substance name:

D-glucopyranose oligomeric tetradecyl glycosides, degree of polymerisation 1

Molecular formula:

C15H30O5

IUPAC Name:

D-glucopyranose oligomeric tetradecyl glycosides, degree of polymerisation 1

Constituent 8

Reference substance name:

D-glucopyranose oligomeric tetradecyl glycosides, degree of polymerisation 2

Molecular formula:

C20H38O9

IUPAC Name:

D-glucopyranose oligomeric tetradecyl glycosides, degree of polymerisation 2

Constituent 9

Reference substance name:

Glucose

EC Number:

200-075-1

EC Name:

Glucose

Cas Number:

50-99-7

Molecular formula:

C6H12O6

IUPAC Name:

D-glucose

Constituent 10

Reference substance name:

Xylose

EC Number:

200-400-7

EC Name:

Xylose

Cas Number:

58-86-6

Molecular formula:

C5H10O5

IUPAC Name:

Oxane-2,3,4,5-tetrol (D)

Constituent 11

Reference substance name:

Tetradecanol

EC Number:

204-000-3

EC Name:

Tetradecanol

Cas Number:

112-72-1

Molecular formula:

C14H30O

IUPAC Name:

Tetradecan-1-ol

Constituent 12

Reference substance name:

Dodecan-1-ol

EC Number:

203-982-0

EC Name:

Dodecan-1-ol

Cas Number:

112-53-8

Molecular formula:

C12H26O

IUPAC Name:

Dodecan-1-ol

Results and discussion

Test results

Test results 1

Key result

Species / strain:

S. typhimurium TA 97

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 3

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 4

Key result

Species / strain:

S. typhimurium TA 102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 5

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 6

Key result

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: on APP-C5 until 5000µg/plate

Any other information on results incl. tables

The category approach is notably based on absence of genome mutation in OECD-471 (reliability 1, GLP) tests. The APP category is clearly not mutagenic in bacterial reverse mutation assays.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

Based on clearly negative bacterial reverse mutation assay (OECD-471) on 2 substances of the category, it can be concluded that all substances of this APP category are not mutagenic under the conditions of a bacterial reverse mutation assay. Please see APP category report for detailed discussion.