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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Link to relevant study records

Referenceopen allclose all

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not determined
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not determined
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not determined
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Conclusions:
Experimental data on in vitro mutagenicity on bacteria are available to 7 representatives of the category of Guerbet alcohols. Due to the similar structure with no additional functional groups these data can be cross-read to the whole category of Guerbet alcohols.
Endpoint:
in vitro cytogenicity / chromosome aberration study in mammalian cells
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reason / purpose for cross-reference:
read-across source
Key result
Species / strain:
lymphocytes: human
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Conclusions:
The test substance 2-hexyldecan-1-ol has shown no evidence of causing an increase in the frequency of structural chromosome aberrations in this in vitro cytogenetic test system, under the experimental conditions described.
Due to the similar structure with no additional functional groups these data can be cross-read to the whole category of Guerbet alcohols.
Executive summary:

The test substance 2 -hexyldecan-1 -ol has shown no evidence of causing an increase in the frequency of structural chromosome aberrations in an in vitro cytogenetic test system, under the experimental conditions described.

Due to the similar structure with no additional functional groups these data can be cross-read to the whole category of Guerbet alcohols.

Endpoint:
in vitro gene mutation study in mammalian cells
Remarks:
Type of genotoxicity: gene mutation
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reason / purpose for cross-reference:
read-across source
Key result
Species / strain:
Chinese hamster Ovary (CHO)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Conclusions:
The test substance 2-hexyldecan-1-ol did not demonstrate mutagenic potential in this in vitro HPRT cell mutation assay, under the experimental conditions described.
Due to the similar structure with no additional functional groups these data can be cross-read to the whole category of Guerbet alcohols.
Executive summary:

The test substance 2-hexyldecan-1-ol did not demonstrate mutagenic potential in this in vitro HPRT cell mutation assay, under the experimental conditions described.

Due to the similar structure with no additional functional groups these data can be cross-read to the whole category of Guerbet alcohols.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Experimental data on in vitro mutagenicity on bacteria are available to 7 representatives of the category of Guerbet alcohols. All tests are negative. Studies on mammalian cells are only available for the C16 Guerbet alcohol 2 -Hexyldecan-1-ol (CAS-No. 2425-77-6). Both a cytogenetic assay (chromosome aberration test) as well as a gene mutation study (HPRT test) are negative. Due to the similar structure with no additional functional groups these data can be cross-read to the whole category of Guerbet alcohols.


Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Avalaible data are conclusive but not sufficient for classification of 2 -dodecylhexadecan-1-ol with regard to mutagenicity / genotoxicity.