Registration Dossier
Registration Dossier
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EC number: 211-119-4 | CAS number: 629-96-9
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Gene mutation (Bacterial reverse mutation assay / Ames test): the related substance docosan-1-ol was negative with and without activation in S. typhimurium strains TA 98, TA100, TA1535, TA1537 and TA 1538 (OECD TG 471) (Iglesias, 2002b).
Gene mutation (Bacterial reverse mutation assay / Ames test): the
related substance Fatty alcohol blend (containing 40.77% C8 and 55.3%
C10) was negative with and without activation in S. typhimurium strains
TA 98, TA100, TA1535, TA1537 and TA 1538 (similar to OECD TG 471)
(Inveresk, 1992).
Cytogenicity in mammalian cells: the related substance docosan-1-ol was
negative with and without activation in Chinese hamster ovary cells
(similar to OECD TG 473) (Iglesias, 2002b).
Mutagenicity in mammalian cells: the related substance docosan-1-ol was
negative with and without activation in Chinese hamster lung V79 cells
(similar to OECD TG 476) (Iglesias, 2002b).
Mutagenicity in mammalian cells: the related substance Fatty alcohol blend (containing 40.77% C8 and 55.3% C10): negative with and without activation in L5178Y mouse lymphoma cells (similar to OECD TG 476) (Inveresk, 1992).
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- no cross linking strain was used
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- (no TA102 or E. coli WP2 uvrA; 2-aminoanthracene only positive control with metabolic activation)
- Principles of method if other than guideline:
- Well-conducted study according to a protocol very similar to OECD guideline 471
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- histidine
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- liver microsomal fractions from male rats prepared by "established methods"
- Test concentrations with justification for top dose:
- 10, 100, 333, 667, and 1000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: solubility - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA100, TA1535 without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-O-phenylenediamine
- Remarks:
- TA98, TA1537, TA1538 without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: aminoanthracene
- Remarks:
- all strains with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: none
- Exposure duration: no data
NUMBER OF REPLICATES:
- two independent experiments, both with and without metabolic activation
- each concentration (including controls) tested in triplicate
DETERMINATION OF CYTOTOXICITY
- Method: no data - Evaluation criteria:
- To be considered positive in TA100, >=2x increase in revertants over spontaneous rate; in TA98, TA1535, TA1537 and TA1538, >=3x increase; alternatively a concentration-dependent increase irrespective of 2- or 3-fold increase
- Statistics:
- none
- Key result
- 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:
- other: not determined, but number of revertants reduced in TA 98 at 1000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: not determined, but number of revertants not reduced at 1000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no data
- Effects of osmolality: no data
- Evaporation from medium: no data
- Water solubility: insoluble
- Precipitation: no data
- Other confounding effects: no data
RANGE-FINDING/SCREENING STUDIES: yes, no data presented
COMPARISON WITH HISTORICAL CONTROL DATA: no
ADDITIONAL INFORMATION ON CYTOTOXICITY: none - Remarks on result:
- other: No mutagenic potential
- Conclusions:
- In a valid and reliable study, behenyl alcohol (C22) did not increase the reverse mutation rate in histidine dependent bacterial strains of Salmonella typhimurium in the presence or absence of metabolic activation at concentrations up to and including 1000 µg/plate. It is concluded that the test substance is negative for mutagenicity in bacteria under the conditions of the test.
- Executive summary:
In the bacterial mutagenicity study, S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 1538 bacteria were incubated with 10, 100, 333, 667, and 1000 µg/plate of test material, with and without metabolic activation. The test material did not increase the reverse mutation rate in histidine dependent bacterial strains of Salmonella typhimurium in the presence or absence of metabolic activation up to limit concentration. The study concludes that the test substance is negative for mutagenicity in bacteria under the conditions of the test. The study was conducted according to a test protocol that is comparable to the appropriate OECD test guideline, with the exception that no cross linking strain was used. Read across to the registered substance is considered scientifically justified.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- not stated
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- without detailed documentation
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- Principles of method if other than guideline:
- Well-conducted study according to protocol very similar to OECD guideline 473
- GLP compliance:
- not specified
- Type of assay:
- in vitro mammalian chromosome aberration test
- Target gene:
- not applicable
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: minimum essential medium
- Properly maintained: no data
- Periodically checked for Mycoplasma contamination: no data
- Periodically checked for karyotype stability: no data
- Periodically "cleansed" against high spontaneous background: no data - Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- liver microsomal fraction from male rats prepared according to Ames et al., 1977
- Test concentrations with justification for top dose:
- 0.6, 10.0 and 20.0 µg/ml
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: solubility - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- without metabolic activation
- Positive control substance:
- ethylmethanesulphonate
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- with metabolic activation
- Positive control substance:
- cyclophosphamide
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation period: not applicable
- Exposure duration: 4 hours
- Expression time (cells in growth medium): not applicable
- Selection time (if incubation with a selection agent): not applicable
- Fixation time (start of exposure up to fixation or harvest of cells): 7 and 24 (or 28) hours at 20 µg/ml, 18 hours at 0.6, 10 and 20 µg/ml
SPINDLE INHIBITOR (cytogenetic assays): Colcemid, 0.2 µg/ml
STAIN (for cytogenetic assays): Giemsa
NUMBER OF REPLICATIONS: 2 cultures per concentration
NUMBER OF CELLS EVALUATED: 100 per slide, 200 per concentration
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index
- Evaluation criteria:
- To be considered positive, either a statistically significant, concentration-related increase in the number of structural chromosome aberrations, or a statistically significant positive response at one of the concentrations
- Statistics:
- Chi-squared test performed for cells with aberration (excluding gaps)
- Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: presumably >20 µg/ml
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no data
- Effects of osmolality: no data
- Evaporation from medium: no data
- Water solubility: insoluble
- Precipitation: no data
- Other confounding effects: no data
RANGE-FINDING/SCREENING STUDIES: yes, but no data presented
COMPARISON WITH HISTORICAL CONTROL DATA: no data
ADDITIONAL INFORMATION ON CYTOTOXICITY: at 20 µg/ml, mitotic index not reduced, plating efficiency not reduced - Remarks on result:
- other: No mutagenic potential
- Conclusions:
- In a reliable study, according to a protocol that is similar to OECD 473, behenyl alcohol (C22) did not increase the incidence of chromosome aberrations in Chinese hamster V79 cells in the presence or absence of metabolising fraction at concentrations up to 20 µg/ml. There was no evidence of cytotoxicity at this dose level.
- Executive summary:
In an in vitro chromosome aberration study, Chinese hamster lung fibroblasts (V79) were incubated with 0.6, 10.0 and 20.0 µg/ml of test material dissolved in ethanol for 4 hours, with and without metabolic activation.
The test substance did not increase the incidence of chromosome aberrations in Chinese hamster V79 cells in the presence or absence of metabolic activation when tested up to limit concentration. There was no evidence of cytotoxicity at this dose level. The study was comparable to guideline without detailed documentation (publication). It is considered that read across to the registered substance is valid and scientifically justifiable.
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- Principles of method if other than guideline:
- Well-conducted study according to a protocol very similar to OECD guideline 476
- GLP compliance:
- not specified
- Type of assay:
- mammalian cell gene mutation assay
- Target gene:
- HGPRT
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: no data
- Properly maintained: no data
- Periodically checked for Mycoplasma contamination: no data
- Periodically checked for karyotype stability: no data
- Periodically "cleansed" against high spontaneous background: no data - Metabolic activation:
- with and without
- Metabolic activation system:
- no data, but for Ames test, liver microsomal fractions from male rats prepared by "established methods"
- Test concentrations with justification for top dose:
- 2.0, 7.5, 15.0, and 20.0 ug/ml
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol, final concentration in culture medium <=1% v/v
- Justification for choice of solvent/vehicle: solubility - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- without metabolic activation
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- 1.0 ug/ml
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- with metabolic activation
- Positive control substance:
- 7,12-dimethylbenzanthracene
- Remarks:
- 15.4 ug/ml
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation period: not applicable
- Exposure duration: 4 hours
- Expression time (cells in growth medium): no data
- Selection time (if incubation with a selection agent): no data
- Fixation time (start of exposure up to fixation or harvest of cells): no data
SELECTION AGENT (mutation assays): thioguanine
NUMBER OF REPLICATIONS:
- 2 independent experiments, both with and without metabolic activation
NUMBER OF CELLS EVALUATED: no data
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - Evaluation criteria:
- To be considered positive, statistically significant concentration-related increase in mutant frequency, or a reproducible and statistically significant positive response for at least one concentration
- Statistics:
- no data
- Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: presumably >20 µg/ml
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no data
- Effects of osmolality: no data
- Evaporation from medium: no data
- Water solubility: insoluble
- Precipitation: no data
- Other confounding effects: no data
RANGE-FINDING/SCREENING STUDIES: yes, but no data presented
COMPARISON WITH HISTORICAL CONTROL DATA: no data
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- With metabolic activation: mean relative cell survival over the test concentrations ranged from 89.1% (20 ug/ml) to 93.8% (15 ug/ml).
- Without metabolic activation: mean relative cell survival ranged from 96% (15 ug/ml) to 120.2 % (20 ug/ml). - Remarks on result:
- other: No mutagenic potential
- Conclusions:
- In a reliable study, behenyl alcohol (C22) did not increase the gene mutation rate in Chinese hamster V79 cells in the presence or absence of metabolic activation at concentrations up to 20 ug/ml. It is concluded that the test substance is negative for mutagenicity in mammalian cells under the conditions of this test.
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- The restrictions were that the range of strains does not comply with current guidelines. Read-across to the registered substance is considered scientifically justified
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- range of strains does not comply with current guidelines
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Histidine operon
- Species / strain / cell type:
- S. typhimurium, other: TA 98; TA 100;TA 1535; TA 1537; TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced rat liver S9
- Test concentrations with justification for top dose:
- Toxicity test: 33, 100, 333, 1000, 3333, 10000 µg/plate; Main experiment: 1.5, 5, 15, 50, 150, 500 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO was used in preliminary toxicity test, and high levels of toxicity demonstrated. At the concentrations used for the mutation assay, acetone was used as solvent as the levels of test substance could not be detected accurately in analysis when DMSO was the solvent.
- Justification for choice of solvent/vehicle: none given in report - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA 1535 and TA 100 without metabolic activation: 2-aminoanthracene
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA 1537 without metabolic activation
- Untreated negative controls:
- other:
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA 1538 and TA 98 without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- all strains with metabolic activation
- Details on test system and experimental conditions:
- ACTIVATION; Aroclor induced rat liver S9; NADP and glucose-6-phosphate as co-factors; 0.5 ml 10% S9 in 2.7 ml agar and test material and test strains.
METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: none
- Exposure duration: 2 days
- Expression time (cells in growth medium): 2 days
SELECTION AGENT (mutation assays): histidine-poor agar
NUMBER OF REPLICATIONS: triplicate plates, two independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: other: condition of bacterial lawn - Evaluation criteria:
- A positive response was recorded if there was a reproducible, dose dependent increase in the number of revertants to at least twice control values for TA 1535, TA 98, TA 1537 and TA 1538, and 1.5 times for strain TA 100.
- Statistics:
- Mean and standard deviation.
- Key result
- Species / strain:
- S. typhimurium, other: TA 98; TA 100;TA 1535; TA 1537; TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 500 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Conclusions:
- Fatty alcohol blend was tested in a bacterial reverse mutation assay according to a protocol that is similar to OECD 471 and under GLP in Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and TA 1538. No increase in the number of revertants per plate was observed with or without activation in either the initial assay or the independent repeat assay. Solvent and positive controls gave expected results. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.
- Executive summary:
Fatty alcohol blend was tested in a bacterial reverse mutation assay according to a protocol that is similar to OECD 471 and under GLP in Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and TA 1538. No increase in the number of revertants per plate was observed with or without activation in either the initial assay or the independent repeat assay. Solvent and positive controls gave expected results. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.
The in vitro and in vivo data available for members of the category and supporting substances indicate that the C6-24 alcohols are not genotoxic. In addition, the category of LCAAs under consideration does not contain any structural elements that are of concern for potential mutagenic activity.
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- GLP compliance:
- yes
- Type of assay:
- mammalian cell gene mutation assay
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced rat liver S9
- Test concentrations with justification for top dose:
- Toxicity assay: 0.4, 4.3, 43.2, 432, 4320 µg/ml; Mutagenicity assay: 9.4, 18.8, 37.5, 75, 150, 300 µg/ml
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO was used in toxicity assay, acetone in mutagenicity assay
- Justification for choice of solvent/vehicle: due to impurity peaks in the chromatograms, solvent was changed to acetone. - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 3-methylcholanthrene
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- ACTIVATION: 1.0 ml S9 mix containing 10% S9 and cofactors NADP and glucose-6-phosphate added to give final volume of 10 ml
METHOD OF APPLICATION: in medium
DURATION
- Preincubation period: none
- Exposure duration: 4 hours
- Expression time (cells in growth medium): 2 days
- Selection time (if incubation with a selection agent): 11-14 days
SELECTION AGENT (mutation assays): trifluorothymidine
NUMBER OF REPLICATIONS: duplicate cultures, independent repeat experiment
DETERMINATION OF CYTOTOXICITY
- Method: other: cloning efficiency - Evaluation criteria:
- A substance was considered positive if there was an increase of at least 1.7 fold in at least one of the highest doses was significant and associated with an increase in mutant numbers and/or an upward trend in the remaining doses, in two experiments under the same activation conditions.
- Statistics:
- Statistical evaluation was performed if marginal responses were recorded.
- Key result
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 43.2 µg/ml
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Conclusions:
- Fatty alcohol blend has been tested according to a protocol that is similar to OECD 476 and under GLP. No increase in the mutant frequency was observed with or without metabolic activation in either the initial or repeat experiment up to cytotoxic concentrations. Solvent and positive controls gave expected results. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.
- Executive summary:
Fatty alcohol blend has been tested according to a protocol that is similar to OECD 476 and under GLP. No increase in the mutant frequency was observed with or without metabolic activation in either the initial or repeat experiment up to cytotoxic concentrations. Solvent and positive controls gave expected results. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.
The in vitro and in vivo data available for members of the category and supporting substances indicate that the C6-24 alcohols are not genotoxic. In addition, the category of LCAAs under consideration does not contain any structural elements that are of concern for potential mutagenic activity.
Referenceopen allclose all
Table 1 Revertants per plate (mean of 3 plates)
Concentration µg/plate |
TA 98 |
TA100 |
TA1535 |
TA1537 |
TA1538 |
|||||
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
|
Negative control |
15.3 |
17.0 |
82.3 |
833.7 |
5.7 |
8.0 |
5.0 |
4.0 |
14.3 |
16.7 |
0* |
15.3 |
15.7 |
83.3 |
77.3 |
8.3 |
8.3 |
7.0 |
5.0 |
14.7 |
15.0 |
10.0 |
14.0 |
19.0 |
70.7 |
80.3 |
10.7 |
9.7 |
3.0 |
5.0 |
14.3 |
14.0 |
100.0 |
9.3 |
15.3 |
85.0 |
82.0 |
7.7 |
9.0 |
4.0 |
4.3 |
14.7 |
15.7 |
333.3 |
11.7 |
15.7 |
80.0 |
79.7 |
8.0 |
12.3 |
4.7 |
5.0 |
15.0 |
15.3 |
666.6 |
12.0 |
12.7 |
74.0 |
82.3 |
8.3 |
6.3 |
4.3 |
5.3 |
14.0 |
15.3 |
1000 |
6.7 |
8.0 |
76.0 |
86.3 |
4.7 |
3.3 |
3.7 |
5.0 |
13.7 |
14.7 |
Positive control |
1573 |
2337.7 |
1158 |
2414 |
601.7 |
345 |
109.7 |
85.3 |
1980 |
495.7 |
* Solvent control with
Table 1 Cytogenicity: 7 hour fixation. Aberrations in 200 cells
Activation |
Concentration µg/ml |
Percent aberrant cells |
||
incl gaps |
excl gaps |
exchanges |
||
Without |
0* |
4.0 |
1.5 |
0 |
20 |
2.5 |
0.5 |
0 |
|
With |
0* |
4.0 |
1.5 |
0 |
20 |
7.0 |
2.5 |
0 |
|
* Solvent control with ethanol
** Only 100 cells counted for positive controls
Table 2 Cytogenicity: 18 hour fixation. Aberrations in 200 cells
Activation |
Concentration µg/ml |
Percent aberrant cells |
||
incl gaps |
excl gaps |
exchanges |
||
Without |
Negative control |
5.5 |
1.5 |
0 |
0* |
4.0 |
1.5 |
0.5 |
|
0.6 |
4.5 |
2.0 |
0 |
|
10 |
4.0 |
1.0 |
0.5 |
|
20 |
3.0 |
0.5 |
0 |
|
Positive control** |
12.0 |
9.0 |
4.0 |
|
With |
Negative control |
2.5 |
1.5 |
0 |
0* |
2.5 |
1.5 |
0.5 |
|
0.6 |
5.5 |
3.0 |
0.5 |
|
10 |
4.0 |
2.5 |
0 |
|
20 |
4.0 |
2.5 |
0.5 |
|
Positive control** |
16.0 |
13.0 |
5.5 |
|
* Solvent control with ethanol
** Only 100 cells counted for positive controls
Table 3 Cytogenicity: 18 hour fixation. Aberrations in 200 cells
Activation |
Concentration µg/ml |
Percent aberrant cells |
||
incl gaps |
excl gaps |
exchanges |
||
Without |
0* |
6.0 |
2.5 |
0.5 |
20 |
3.5 |
2.0 |
0 |
|
With |
0* |
1.0 |
0.5 |
0 |
20 |
4.0 |
2.5 |
0.5 |
|
* Solvent control with ethanol
** Only 100 cells counted for positive controls
Table 1 Results of mutagenicity in V79 cells (mean of 2 cultures)
Concentration µg/ml |
Mean relative cell survival (%) |
Mean mutants per culture |
Mutant colonies per 10 E06 cells |
|||
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
|
Negative |
105.1 |
98.2 |
2.7 |
4.8 |
8.65 |
47.4 |
0* |
100 |
100 |
4.5 |
2.1 |
14.7 |
8.75 |
2 |
101.3 |
92.55 |
4.1 |
6.3 |
12.5 |
21.65 |
7.5 |
102.4 |
93.6 |
5.4 |
4.9 |
16.1 |
15.75 |
15 |
96.0 |
93.8 |
3.4 |
1.7 |
12.3 |
6.35 |
20 |
120.2 |
89.1 |
4.3 |
4.4 |
17.9 |
16.95 |
Positive control |
67.3 |
104.6 |
156.7 |
39.1 |
1143.7 |
163.4 |
Table 1 Experiment 1: Reversions per plate (mean of 3 plates)
Concentration µg/plate |
TA 1535 |
TA 1537 |
TA 1538 |
TA 98 |
TA 100 |
|||||
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
|
0* |
18 |
23 |
10 |
14 |
23 |
19 |
26 |
39 |
124 |
132 |
Positive control |
245 |
250 |
1334 |
150 |
286 |
569 |
186 |
522 |
747 |
598 |
1.5 |
18 |
15 |
14 |
16 |
18 |
14 |
24 |
31 |
121 |
145 |
5 |
17 |
17 |
18 |
17 |
19 |
21 |
32 |
35 |
147 |
136 |
15 |
15 |
21 |
16 |
14 |
18 |
20 |
25 |
36 |
130 |
115 |
50 |
14 |
15 |
8 |
16 |
18 |
13 |
22 |
33 |
121 |
110 |
150 |
14 |
19 |
8 |
16 |
13 |
20 |
23 |
27 |
119 |
118 |
500 |
10 |
13 |
2 |
6 |
3 |
7 |
7 |
20 |
58 |
89 |
* solvent control acetone
Table 2 Experiment 2: Reversions per plate (mean of 3 plates)
Concentration µg/plate |
TA 1535 |
TA 1537 |
TA 1538 |
TA 98 |
TA 100 |
|||||
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
|
0* |
14 |
16 |
11 |
11 |
20 |
26 |
30 |
31 |
129 |
123 |
Positive control |
262 |
178 |
1331 |
166 |
235 |
252 |
224 |
247 |
557 |
523 |
1.5 |
13 |
15 |
8 |
10 |
19 |
24 |
28 |
28 |
125 |
112 |
5 |
20 |
12 |
14 |
14 |
19 |
21 |
28 |
34 |
136 |
121 |
15 |
19 |
17 |
14 |
14 |
20 |
25 |
26 |
35 |
137 |
111 |
50 |
21 |
17 |
14 |
7 |
18 |
17 |
21 |
25 |
129 |
105 |
150 |
18 |
16 |
11 |
8 |
13 |
18 |
24 |
27 |
112 |
109 |
500 |
- |
12 |
- |
5 |
- |
6 |
- |
23 |
- |
59 |
* solvent control acetone
Table 1 Experiment 1 Mutant frequency (average of 3 plates per culture)
Concentration µg/ml |
Relative total growth % |
Mean mutant count (MC) |
Mutant fraction x 10¿¿ |
Increase over control |
||||
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
|
Solvent control |
81 |
92 |
19 |
24 |
27 |
36 |
-
|
- |
112 |
103 |
32 |
25 |
35 |
36 |
|||
102 |
101 |
25 |
31 |
30 |
35 |
|||
104 |
103 |
26 |
27 |
31 |
32 |
|||
Positive control |
75 |
34 |
182 |
151 |
264 |
299 |
8.6 |
7.6 |
63 |
38 |
150 |
135 |
268 |
235 |
|||
9.4 |
129 |
85 |
17 |
30 |
21 |
36 |
1.0 |
0.9 |
100 |
88 |
29 |
18 |
39 |
26 |
|||
18.8 |
111 |
92 |
27 |
21 |
31 |
25 |
1.2 |
0.7 |
109 |
71 |
39 |
19 |
44 |
24 |
|||
37.5 |
72 |
92 |
18 |
24 |
25 |
34 |
0.9 |
1.0 |
79 |
71 |
27 |
27 |
33 |
35 |
|||
75 |
- |
- |
NP |
NP |
- |
- |
- |
- |
- |
- |
NP |
NP |
- |
- |
|||
150 |
- |
- |
NP |
NP |
- |
- |
- |
- |
- |
- |
NP |
NP |
- |
- |
|||
300 |
- |
- |
NP |
NP |
- |
- |
- |
- |
- |
- |
NP |
NP |
- |
|
|||
NP = Not plated, too toxic for assessment
Table 2 Experiment 2 Mutant frequency (average of 3 plates per culture)
Concentration µg/ml |
Relative total growth % |
Mean mutant count (MC) |
Mutant fraction x 10¿¿ |
Increase over control |
||||
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
|
Solvent control |
94 |
99 |
25 |
35 |
28 |
43 |
- |
- |
113 |
110 |
30 |
41 |
26 |
43 |
|||
92 |
99 |
29 |
31 |
28 |
37 |
|||
- |
93 |
- |
30 |
- |
37 |
|||
Positive control |
84 |
20 |
152 |
107 |
182 |
315 |
7.5 |
7.7 |
83 |
21 |
172 |
122 |
221 |
298 |
|||
10 |
103 |
- |
31 |
NP |
33 |
- |
1.3 |
- |
98 |
- |
32 |
NP |
39 |
- |
|||
20 |
128 |
- |
30 |
NP |
29 |
- |
1.1 |
- |
86 |
- |
28 |
NP |
29 |
- |
|||
30 |
93 |
90 |
21 |
27 |
26 |
30 |
1.1 |
0.9 |
91 |
79 |
29 |
40 |
32 |
39 |
|||
40 |
57 |
90 |
34 |
38 |
48 |
42 |
1.3 |
0.9 |
84 |
94 |
20 |
29 |
22 |
33 |
|||
50 |
32 |
91 |
20 |
31 |
26 |
31 |
1.0 |
0.8 |
29 |
93 |
21 |
32 |
30 |
36 |
|||
60 |
- |
71 |
NP |
36 |
- |
36 |
- |
0.8 |
- |
56 |
NP |
24 |
- |
28 |
|||
70 |
- |
37 |
NP |
22 |
- |
25 |
- |
0.6 |
- |
23 |
NP |
25 |
- |
26 |
|||
80 |
- |
- |
NP |
NP |
- |
- |
- |
- |
- |
- |
NP |
NP |
- |
- |
|||
NP = Not plated: 3 highest dose levels, too toxic for assessment
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
Mouse micronucleus study: the related substance docosan-1-ol was negative in bone marrow (similar to OECD TG 474) (Iglesias, 2002b).
Micronucleus study in mice: the related substance Fatty alcohol blend (containing 40.77% C8 and 55.3% C10) was negative after oral administration (Inveresk, 1992).
Link to relevant study records
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- not stated
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Only 1000 erythrocytes were scored per animal, full experimental details were not reported, toxicity details were lacking. It was not compliant with GLP.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- yes
- Remarks:
- (only 1000 PCEs per animal scored for micronuclei)
- Principles of method if other than guideline:
- Well-conducted study according to protocol very similar to OECD guideline 474
- GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL Tierfarm Fullinsdorf, Switzerland
- Age at study initiation: >=10 weeks
- Weight at study initiation: no data
- Assigned to test groups randomly: no data
- Fasting period before study: 18 hours, but continued to receive water ad libitum
- Housing: Markrolon Type 1 cages with wire mesh tops and granulated soft wood bedding
- Diet (e.g. ad libitum): standard pellet diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): not regulated
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: no data - Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: polyethylene glycol
- Justification for choice of solvent/vehicle: no data
- Concentration of test material in vehicle: no data [calculated: 5, 15 and 50 mg/ml]
- Amount of vehicle (if gavage or dermal): 10 ml/kg bw
- Lot/batch no. (if required): no data
- Purity: no data - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: few details; test material suspended in vehicle
- Duration of treatment / exposure:
- single administration
- Frequency of treatment:
- single administration
- Post exposure period:
- none
- Dose / conc.:
- 50 mg/kg bw/day (nominal)
- Dose / conc.:
- 150 mg/kg bw/day (nominal)
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 6
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide
- Justification for choice of positive control(s): no data
- Route of administration: presumably oral gavage
- Doses / concentrations: 40 mg/kg bw - Tissues and cell types examined:
- bone marrow cells
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: based on previous study - 500 mg/kg bw estimated to be the "maximum attainable dose"
TREATMENT AND SAMPLING TIMES (in addition to information in specific fields): 24, 48 and 72 hours after dosing
DETAILS OF SLIDE PREPARATION: femurs removed, marrow flushed out with foetal calf serum, cell suspension centrifuged and supernatant discarded, small drop of cell pellet spread on slide, air dried, stained with May-Grunwald, mounted; 1 slide/sample
METHOD OF ANALYSIS: 1000 polychromatic erythrocytes (PCEs) scored for micronuclei; polychromatic:normochromatic (PCE:NCE) ratio scored
OTHER: only 5/sex per dose level evaluated - Evaluation criteria:
- To be considered positive, either a statistically significant dose-related increase in the number of micronucleated PCEs or a reproducible, statistically significant positive response for at least one dose level
- Statistics:
- Mann-Whitney test
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Remarks:
- presumably toxic at >500 mg/kg bw
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range: no data
- Solubility: no data
- Clinical signs of toxicity in test animals: no data
- Evidence of cytotoxicity in tissue analyzed: no data
- Rationale for exposure: no data
- Harvest times: no data
- High dose with and without activation: no data
- Other: presumably toxic above 500 mg/kg bw since this maximum dose was chosen for the main study on the basis of the results of the range-finding study
RESULTS OF DEFINITIVE STUDY
- Induction of micronuclei (for Micronucleus assay): 0.03-0.09% for vehicle controls, 0.04-0.10% for test material treated, 0.71% for positive control
- Ratio of PCE/NCE (for Micronucleus assay): 1.05-1.27 for vehicle controls, 0.98-1.55 for test material treated, 0.93 for positive control
- Appropriateness of dose levels and route: appropriate (top dose was apparently the maximum tolerated dose, oral route relevant to humans)
- Statistical evaluation: no statistically significant increases in the frequency of micronuclei in mice treated with the test material; statistical significance not presented for positive control - Conclusions:
- In a reliable study, behenyl alcohol (C22) did not increase the incidence of micronuclei in mouse bone marrow cells after a single oral gavage dose of up to 500 mg/kg bw.
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 November 1991 to 11 February 1332
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- yes
- Remarks:
- only 1000 PCE per animal were scored for micronuclei
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Limited, Manston Road, Kent
- Age at study initiation: 5-7 weeks
- Weight at study initiation: 27-30 g (males) 18-23 g (females)
- Assigned to test groups randomly: yes
- Fasting period before study: no information
- Housing: individually in polypropylene/stainless steel cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 10 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19
- Humidity (%): 38
- Air changes (per hr): no information
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: corn oil
- Justification for choice of solvent/vehicle: none given; standard vehicle
- Concentration of test material in vehicle: sufficient to give required dose in appropriate volume of vehicle
- Amount of vehicle (if gavage or dermal): 10 mg/ml/day - Duration of treatment / exposure:
- Animals were dosed on three consecutive days.
- Frequency of treatment:
- daily
- Post exposure period:
- 96 hours
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Dose / conc.:
- 2 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 5 (positive control, low and mid dose) or 10 (vehicle control, high dose)
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- - Positive control substance: cyclophosphamide
- Justification for choice of positive control(s): none given - standard positive control
- Route of administration: no information
- Doses / concentrations: 40 mg/ kg bw - Tissues and cell types examined:
- Bone marrow
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: no deaths occurred in preliminary toxicity assay
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): Animals dosed at 0, 24 and 48 hours; samples taken at 72 and 96 hours
DETAILS OF SLIDE PREPARATION: Air dried slides were fixed in methanol then stained with 1% May-Grunwald for 5 minutes then counterstained in 15% Giesma for 15 minutes
METHOD OF ANALYSIS: 1000 PCE scored for micronuclei; PCE/NCE ratio was determined for 300 cells, using x 1000 oil immersion objective - Evaluation criteria:
- An increase in micronucleus frequency of greater than 0.28%.
- Statistics:
- No statistical evaluation described.
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Conclusions:
- Fatty alcohol blend has been tested according to OECD 474 and under GLP. Male and female mice were dosed with 500, 1000 and 2000 mg/kg bw. No increase in the number of micronucleated PCE was observed (1000 PCE scored per animal). It is concluded that the test substance is negative for the induction of micronuclei under the conditions of the test. No toxicity to bone marrow or general toxicity was observed.
- Executive summary:
Fatty alcohol blend has been tested according to OECD 474 and under GLP. Male and female mice were dosed with 500, 1000 and 2000 mg/kg bw. No increase in the number of micronucleated PCE was observed (1000 PCE scored per animal). It is concluded that the test substance is negative for the induction of micronuclei under the conditions of the test. No toxicity to bone marrow or general toxicity was observed.
Referenceopen allclose all
Toxicity unclear, but possibly one male and one female mouse [per group?] died either spontaneously or due to gavage error.
Table 1 Results of micronucleus assay 24 hour sampling time
Treatment |
Suspending agent |
Low dose |
Mid dose |
High dose |
Concentration mg/kg bw |
0 |
40 |
50 |
150 |
Harvest time |
24 |
24 |
24 |
24 |
Micronucleated PCE (%) |
0.03 |
0.71 |
0.07 |
0.08 |
Ratio PCE/NCE |
1.27 |
0.93 |
0.98 |
1.07 |
Table 2 Results of micronucleus assay 48 hour sampling time
Treatment |
Suspending agent |
Test substance |
Test substance |
Test substance |
Concentration mg/kg bw |
0 |
50 |
150 |
500 |
Harvest time |
48 |
48 |
48 |
48 |
Micronucleated PCE (%) |
0.09 |
0.1 |
0.04 |
0.05 |
Ratio PCE/NCE |
1.05 |
1.06 |
1.01 |
1.23 |
Table 3 Results of micronucleus assay 72 hour sampling time
Treatment |
Suspending agent |
Low dose |
Mid dose |
High dose |
Concentration mg/kg bw |
0 |
50 |
150 |
500 |
Harvest time |
72 |
72 |
72 |
72 |
Micronucleated PCE (%) |
0.09 |
0.09 |
0.05 |
0.07 |
Ratio PCE/NCE |
1.41 |
1.33 |
1.55 |
1.46 |
Table 1 Results of in vivo micronucleus study
Treatment mg/kg.bw /day |
Time of dosing (h) |
Time of sampling (h) |
Sex |
No. of surviving dosed mice |
Erythrocytes |
|||
Polychromatic cells (PCE) |
Mean PCE/NCE
|
|||||||
PCE Analysed |
No. of MN-PCE |
% MN-PCE |
||||||
Negative control |
0+24+48 |
72 |
M/F |
10 |
10000 |
14 |
0.14 |
0.93 |
96 |
M/F |
10 |
10000 |
10 |
0.10 |
1.02 |
||
Positive control |
0+24+48 |
72 |
M/F |
10 |
10000 |
150* |
1.50 |
0.46 |
500 |
0+24+48 |
72 |
M/F |
10 |
10000 |
9 |
0.09 |
1.00 |
1000 |
0+24+48 |
72 |
M/F |
10 |
10000 |
9 |
0.09 |
0.94 |
2000 |
0+24+48 |
72 |
M/F |
10 |
10000 |
8 |
0.08 |
0.86 |
96 |
M/F |
10 |
10000 |
24 |
0.24 |
0.90 |
||
PCE = Polychromatic erythrocytes
MN-PCE = Micronucleated PCE
MN-PCE = Micronucleated NCE
* = Positive response in PCE
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
There is no information on the genetic toxicity of icosan-1-ol, so key studies were chosen from studies on closely related linear or branched alcohols of similar chain length, including a study on an unsaturated alcohol. The choice of key study was based on reliability and similarity of chain length. The data available from standard in vitro and in vivo genetic toxicity assays for all related substances show no evidence of mutagenic potential.
Discussion of trends in the Category of C6-24 linear and essentially-linear aliphatic alcohols:
The in vitro and in vivo data available for members of the category and supporting substances indicate that the C6-24 alcohols are not genotoxic. In addition, the category of LCAAs under consideration does not contain any structural elements that are of concern for potential mutagenic activity (Ashby and Tenant, 1991). Furthermore, primary LCAAs (linear and branched) in the range C1 to C5 do not have a mutagenic potential (Bevan, 2001; OECD SIDS butan-1-ol, 2001). Moreover, in a review by WHO-JECFA a series of 22 saturated aliphatic branched-chain primary LCAAs and the corresponding aldehydes and acids in the range C4 to C8 showed no activity in a battery of in vitro and in vivo mutagenicity tests (WHO, 1999). On this basis it is concluded that the category of LCAAs does not have a mutagenic potential and that read-across within the category can be justified. Where data gaps exist, the gap is filled by read-across from reliable evidence within the C6-24 Alcohols Category, where possible using interpolation between at least two reliable studies using higher and lower carbon number test substances.
It is concluded that the category C6-24 LCAAs do not have a genotoxic potential.
Conclusion:
The category C6-24 LCAAs do not have a genotoxic potential.
Genetic toxicity of LCAAs
|
CAS |
CHEMICAL NAME |
Bacterial mutagenicity |
Bacterial mutagenicity |
Mammalian cytogenicity |
Mammalian cytogenicity |
Mamalian mutagenicity |
Mamalian mutagenicity |
In vivostudies |
In vivostudies |
|
|
|
Result (Rel.) |
Reference |
Result (Rel.) |
Reference |
Result (Rel.) |
Reference |
Result (Rel.) |
Study Type*(Ref) |
C6 |
111-27-3 |
Hexan-1-ol |
Neg; (1) |
Henkel, 1990 |
|
|
|
|
|
|
C7, 8 and 9 |
|
Alcohols, C7-9 |
Neg. (1) |
Shell, 1996 |
|
|
|
|
|
|
C8 |
111-87-5 |
Octan-1-ol |
Neg; (2) |
Henkel, 1982a; HLS, 1996k |
|
|
|
|
|
|
C8-10 |
none |
Fatty alcohol blend (40.7% C8 and 55.3% C10) Supporting Substance |
Neg(2) |
Dillon, D.M., McCartney, M.A. (1992) |
|
|
Neg (1) |
Cattanach, P., Riach, C. (1992) |
Neg (1) |
Micronucleus (Holstrom, M., Innes, D. (1992)) |
C10 |
112-30-1 |
Decan-1-ol |
Neg (4) 2 strains only
|
(HLS, 1996l) |
|
|
|
|
|
|
C12 |
112-53-8 |
Dodecan-1-ol |
Neg. (1)l |
(Thompson, 1996a)Shimizu, 1985 |
|
|
|
|
Neg. (2) |
Micronucleus; (Banduhn, 1992) |
C12 and 13 |
75782-87-5 |
Alcohols, C12-13 |
Neg (2, >80% lin) |
Dean, 1980 |
|
|
|
|
|
|
C12 and 13 |
740817-83-8 |
Alcohols, C12-13-branched and linear |
Neg (1 50% lin), |
Sasol, 1998f |
Neg (1 (50% lin) |
Sasol, 1998 g |
|
|
|
|
C12 |
67762-25-8 |
C12-18 Alcohols, Type B Supporting |
Neg (2)Ames |
Henkel 1982c |
|
|
|
|
|
|
C 12-15 |
90604-40-3 |
Alcohols, C12-15-branched and linear |
Neg (1) |
Ballantyne, 1996 |
|
|
|
|
|
|
C14 |
112-72-1 |
Tetradecan-1-ol |
Neg (1) |
Thompson, 1996b |
|
|
|
|
|
|
C16 |
36653-82-4 |
Hexadecan-1-ol |
Neg (1) |
Thompson, 1996c |
|
|
|
|
|
|
C16 |
36653-82-4 |
Hexadecan-1-ol |
Neg. (2) |
Henkel, 1981d |
|
|
|
|
|
|
C16 |
68002-94-8 |
C16-18 and C18 Unsaturated Supporting |
Neg. Ames (2) |
Banduhn, 1989) |
|
|
|
|
|
|
C18 |
112-92-5 |
Octadecan-1-ol |
Neg (1)
|
Thompson, 1996d
|
|
|
|
|
Neg (2) MN |
Hachiya, 1982 |
C18 |
112-92-5 |
Octadecan-1-ol |
Neg(2) |
Henkel, 1981f |
|
|
|
|
|
|
C18 |
97552-91-5 |
C18-22 Alcohol Supporting |
Neg. Ames (2) |
Banduhn 1995 |
|
|
|
|
|
|
C22 |
661-19-8 |
Docosan-1-ol |
Neg (2),
|
Iglesias, 2002a, Thompson, 1997 |
Neg (2), |
Iglesias, 2002a |
Neg (2) |
Iglesias, 2002a |
Neg (2) |
Micronucleus Iglesias, 2002aª |
C24-32 |
|
D-002*** Supporting substance |
|
|
|
|
|
|
Neg (4) |
MN; Dom. Leth.Rodeiro 1998a |
* MN: Mouse bone marrow micronucleus test; Dom. Leth. Mouse Dominant Lethal test; UDS: Unscheduled DNA Synthesis assay
** Tested in S. typhimurium TA 98 and TA100, only.
***Mixture of very long chain fatty alcohols from hydrolysed beeswax
References:
Ashby, J., Tennant, R.W., 1991. Definitive relationships among chemical structure, carcinogenicity, and mutagenicity for 301 chemicals tested by the US NTP. Mutation Research 257, 229–306.
WHO, 1999. Technical Report Series 884 Evaluation of certain food additives and contaminants. 49th Report of the Joint FAO/WHO Expert Committee on Food Additives (JECFA), Geneva.
Justification for classification or non-classification
Based on the available data, icosan-1 -ol does not require classification for genetic toxicity according to Regulation (EC) No 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
