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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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:
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

Constituent 1
Reference substance name:
D-pentose, oligomeric, C10 and C12 alkyl glycosides
EC Number:
940-644-8
IUPAC Name:
D-pentose, oligomeric, C10 and C12 alkyl glycosides

Results and discussion

Test resultsopen allclose all
Key result
Species / strain:
S. typhimurium TA 97
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Untreated negative controls validity:
not valid
Positive controls validity:
not valid
Key result
Species / strain:
S. typhimurium TA 102
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Untreated negative controls validity:
not valid
Positive controls validity:
not valid
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Untreated negative controls validity:
not valid
Positive controls validity:
not valid

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.