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EC number: 244-971-0 | CAS number: 22413-03-2
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Ames test: negative in S. typhimurium TA 1535, TA 1537, TA 100, TA 98 and E. coli WP2 uvrA with and without metabolic activation
Chromosome aberration: negative in Chinese hamster lung fibroblasts (V79) and in primary human peripheral lymphocytes with and without metabolic activation
(read-across from CAS 3687-45-4 and CAS 93803-87-3, WoE)
Gene mutation in mammalian cells: negative in Chinese hamster lung fibroblasts (V79) with and without metabolic activation
Read-across from CAS 3687-45-4, key)
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:
- 26 Sep - 18 Oct 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted Jul 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- National Institute of Pharmacy, Budapest, Hungary
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- his operon (for S. typhimurium strains), trp operon (for E. coli strains)
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with phenobarbital and β-naphthoflavone
- Test concentrations with justification for top dose:
- Pre-experiment for toxicity:
10, 31.6, 100, 316, 1000, 2500 and 5000 µg/plate with and without metabolic activation for TA98 and TA100
Based on the results of the pre-experiment the following concentrations were chosen for the main experiment for all strains:
First experiment: 5, 15.81, 50, 158.1, 500, 1581 and 5000 µg/plate with and without metabolic activation
Second experiment: 1.581, 5, 15.81, 50, 158.1, 500, 1581 and 5000 µg/plate with and without metabolic activation - Vehicle / solvent:
- - Solvents used: DMF
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-1,2-phenylene-diamine: -S9: 4 µg/plate for TA98; 2-aminoanthracene: +S9: 2 µg/plate for all S. typhimurium strains and 50 µg/plate for WP2uvrA
- Remarks:
- The biological activity in the Salmonella assay of S9 was characterized using the two mutagens 2-Aminoanthracene and Benzo(a)pyrene, that requires metabolic activation by microsomal enzymes. The batch of S9 used in this study functioned appropriately.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation, 1st experiment); preincubation (2nd experiment)
DURATION
- Preincubation period: 20 min (preincubation method)
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: Triplicates each in 2 independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: number of revertant colonies - Evaluation criteria:
- The colony numbers on the untreated / negative (vehicle/solvent) / positive control and test item treated plates were determined by manual counting. Visual examination of the plates was also performed; precipitation or signs of growth inhibition (if any) were recorded and reported. The mean number of revertants per plate, the standard deviation and the mutation factor (mean number of revertants on the test item plate / mean number of revertants on the vehicle control plate) values were calculated for each concentration level of the test item and for the controls using Microsoft ExcelTM software.
Criteria for Validity:
The study was considered valid if:
- the number of revertant colonies of the negative (vehicle/solvent) and positive controls were in the historical control range in all strains of the main tests;
- at least five analyzable concentrations were presented in all strains of the main tests.
Criteria for a Positive Response:
A test item was considered mutagenic if:
- a dose–related increase in the number of revertants occurred and/or;
- a reproducible biologically relevant positive response for at least one of the dose groups occurred in at least one strain with or without metabolic activation.
An increase was considered biologically relevant if:
- in all strains: the number of reversion was more than two times higher than the reversion rate of the negative (solvent) control.
According to the guidelines, statistical method may be used as an aid in evaluating the test results. However, statistical significance should not be the only determining factor for a positive response.
Criteria for a Negative Response:
A test article was considered non-mutagenic if it produced neither a dose-related increase in the number of revertants nor a reproducible biologically relevant positive response at any of the dose groups, with or without metabolic activation. - Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Remarks:
- Reduced background lawn was observed at 1581 µg/plate without metabolic activation in the pre-incubation method.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Remarks:
- Slightly reduced and reduced background lawn was observed at 1581 and 5000 µg/plate without metabolic activation in the pre-incubation method, respectively.
- Vehicle controls validity:
- valid
- 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, but tested up to precipitating concentrations
- Remarks:
- Reduced background lawn was observed at 5000 µg/plate without metabolic activation in the pre-incubation method.
- Vehicle controls validity:
- valid
- 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, but tested up to precipitating concentrations
- Remarks:
- Slightly reduced background lawn was observed at 158.1 µg/plate and higher without metabolic activation in the pre-incubation method.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Precipitate or slight precipitate was observed in all tester strains at 1581 and 5000 µg/plate with and without metabolic activation.
RANGE-FINDING/SCREENING STUDIES: Lower or slightly reduced numbers of revertant colonies (compared to the solvent control plates) were observed in Salmonella typhimurium TA98 bacterial strain with metabolic activation, although no effect on the background lawn was observed. However, they had no biological significance, and this fact did not affect the proper dose selection.
HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)
- Positive historical control data: The positive control values were within the range of the historical control data and therefore considered to be valid (please refer to table 1 under "any other information on materials and methods incl. tables").
- Negative (solvent/vehicle) historical control data: The negative control values were within the range of the historical control data and therefore considered to be valid (please refer to table 1 under "any other information on materials and methods incl. tables"). - Conclusions:
- Based on the results of the conducted study, the test substance did not show mutagenic properties in S. typhimurium TA 1535, TA 1537, TA 100, TA 98 and E. coli WP2 uvrA with and without metabolic activation.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Remarks:
- Summary of available data used for the endpoint assessment of the target substance
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- refer to analogue justification provided in IUCLID section 13
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Species / strain:
- lymphocytes: cultured human peripheral lymphocytes
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other: Source: CAS 93803-87-3
- Conclusions:
- Based on the results of available in vitro mammalian chromosome aberration studies (OECD 473) in Chinese hamster lung fibroblasts (V79) with the source substance octadec-9-enyl oleate (CAS 3687-45-4) and in primary peripheral human lymphocytes with the source substance 2-octyldodecyl isooctadecanoate (CAS 93803-87-3) no clastogenic properties were determined. Applying the analogue approach, for the target substance docosyl stearate (CAS 22413-03-2) no clastogenic properties are anticipated.
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- refer to analogue justification provided in IUCLID section 13
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Remarks:
- precipitation at limit of water solubility at 100 µg/mL observed.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Source: CAS 3687-45-4
- Conclusions:
- Based on the results of the in vitro mammalian gene mutation study (OECD 476) in Chinese hamster lung fibroblasts (V79) with the source substance octadec-9-enyl oleate (CAS 3687-45-4) no mutagenic properties were found. Applying the analogue approach, for the target substance docosyl stearate (CAS 22413-03-2) no mutagenic properties on mammalian cells are anticipated.
Referenceopen allclose all
Table 2: Results of the pre-experiment for toxicity
| Concentrations (µg/plate) | Mean values of revertants / Mutation factor (MF) | Salmonella typhimuriumtester strains | |||
| TA98 | TA100 | ||||
| -S9 | +S9 | -S9 | +S9 | ||
| Untreated control | Mean | 17.0 | 20.3 | 121.0 | 125.3 |
| MF | 0.98 | 0.51 | 1.08 | 0.87 | |
| Distilled water control | Mean | - | - | 114.7 | - |
| MF | - | - | 1.02 | - | |
| DMSO control |
Mean | 19.7 | 19.7 | - | 153.0 |
| MF | 1.13 | 0.49 | - | 1.06 | |
| DMF control |
Mean | 17.3 | 40.0 | 112.3 | 143.7 |
| MF | 1.00 | 1.00 | 1.00 | 1.00 | |
| 5000 | Mean | 15.0 | 25.7 | 96.0 | 103.3 |
| MF | 0.87 | 0.64 | 0.85 | 0.72 | |
| 2500 | Mean | 17.3 | 18.3 | 122.0 | 117.7 |
| MF | 1.00 | 0.46 | 1.09 | 0.82 | |
| 1000 | Mean | 15.0 | 17.7 | 115.0 | 124.7 |
| MF | 0.87 | 0.44 | 1.02 | 0.87 | |
| 316 | Mean | 15.0 | 18.3 | 123.0 | 141.0 |
| MF | 0.87 | 0.46 | 1.09 | 0.98 | |
| 100 | Mean | 15.7 | 17.0 | 134.0 | 149.3 |
| MF | 0.90 | 0.43 | 1.19 | 1.04 | |
| 31.6 | Mean | 14.0 | 21.7 | 121.0 | 130.7 |
| MF | 0.81 | 0.54 | 1.08 | 0.91 | |
| 10 | Mean | 17.0 | 24.0 | 134.3 | 123.7 |
| MF | 0.98 | 0.60 | 1.20 | 0.86 | |
| NPD (4 µg) | Mean | 235.3 | - | - | - |
| MF | 11.97 | - | - | - | |
| 2AA (2 µg) | Mean | - | 2444.0 | - | 2794.7 |
| MF | - | 124.27 | - | 18.27 | |
| SA (2 µg) | Mean | - | - | 1273.3 | - |
| MF | - | - | 11.10 | - | |
NPD: 4-nitro-1,2-phenylene-diamine
2AA: 2-aminoanthracene
SA: sodium azide
MF: mutation factor
Table 3: Summary of Experiment I (plate incorporation)
| Concentrations (µg/plate) | Mean values of revertants / Mutation factor (MF) | Salmonella typhimuriumtester strains | Escherichia coli | ||||||||
| TA98 | TA100 | TA1535 | TA1537 | WP2uvrA | |||||||
| -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | ||
| Untreated control | Mean | 25.7 | 29.3 | 111.0 | 127.3 | 9.0 | 10.0 | 8.0 | 9.7 | 25.7 | 39.0 |
| MF | 1.60 | 1.06 | 0.89 | 0.91 | 0.87 | 1.20 | 0.75 | 1.21 | 1.40 | 1.27 | |
| Distilled water control | Mean | - | - | 124.0 | - | 7.3 | - | - | - | 25.3 | - |
| MF | - | - | 0.99 | - | 0.71 | - | - | - | 1.38 | - | |
| DMSO control |
Mean | 21.0 | 36.3 | - | 210.7 | - | 7.7 | 8.0 | 8.3 | - | 46.7 |
| MF | 1.31 | 1.31 | - | 1.50 | - | 0.92 | 0.75 | 1.04 | - | 1.52 | |
| DMF control |
Mean | 16.0 | 27.7 | 125.3 | 140.3 | 10.3 | 8.3 | 10.7 | 8.0 | 18.3 | 30.7 |
| MF | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 | |
| 5000 | Mean | 21.0 | 26.3 | 104.7 | 123.3 | 8.3 | 11.3 | 9.7 | 7.7 | 23.0 | 41.3 |
| MF | 1.31 | 0.95 | 0.84 | 0.88 | 0.81 | 1.36 | 0.91 | 0.96 | 1.25 | 1.35 | |
| 1581 | Mean | 29.3 | 26.3 | 115.3 | 126.0 | 11.7 | 11.0 | 7.0 | 8.7 | 27.0 | 33.7 |
| MF | 1.83 | 0.95 | 0.92 | 0.90 | 1.13 | 1.32 | 0.66 | 1.08 | 1.47 | 1.10 | |
| 500 | Mean | 22.3 | 26.0 | 123.0 | 151.7 | 7.7 | 6.0 | 11.7 | 9.0 | 27.7 | 39.7 |
| MF | 1.40 | 0.94 | 0.98 | 1.08 | 0.74 | 0.72 | 1.09 | 1.13 | 1.51 | 1.29 | |
| 158.1 | Mean | 25.3 | 30.0 | 133.0 | 151.0 | 7.3 | 7.0 | 7.7 | 8.3 | 24.3 | 36.3 |
| MF | 1.58 | 1.08 | 1.06 | 1.08 | 0.71 | 0.84 | 0.72 | 1.04 | 1.33 | 1.18 | |
| 50 | Mean | 23.7 | 26.0 | 130.0 | 151.7 | 6.7 | 8.3 | 8.0 | 8.0 | 29.3 | 33.0 |
| MF | 1.48 | 0.94 | 1.04 | 1.08 | 0.65 | 1.00 | 0.75 | 1.00 | 1.60 | 1.08 | |
| 15.81 | Mean | 21.0 | 22.0 | 122.7 | 134.7 | 5.3 | 10.0 | 7.3 | 10.3 | 30.7 | 39.3 |
| MF | 1.31 | 0.80 | 0.98 | 0.96 | 0.52 | 1.20 | 0.69 | 1.29 | 1.67 | 1.28 | |
| 5 | Mean | 19.3 | 25.3 | 119.3 | 139.0 | 4.7 | 9.3 | 8.3 | 5.3 | 28.7 | 32.7 |
| MF | 1.21 | 0.92 | 0.95 | 0.99 | 0.45 | 1.12 | 0.78 | 0.67 | 1.56 | 1.07 | |
| NPD (4 µg) | Mean | 289.3 | - | - | - | - | - | - | - | - | - |
| MF | 13.78 | - | - | - | - | - | - | - | - | - | |
| 2AA (2 µg) | Mean | - | 2400.0 | - | 2273.3 | - | 214.0 | - | 125.3 | - | - |
| MF | - | 66.06 | - | 10.79 | - | 27.91 | - | 15.04 | - | - | |
| 2AA (50 µg) | Mean | - | - | - | - | - | - | - | - | - | 253.3 |
| MF | - | - | - | - | - | - | - | - | - | 5.43 | |
| SA (2 µg) | Mean | - | - | 1244.0 | - | 1101.3 | - | - | - | - | - |
| MF | - | - | 10.03 | - | 150.18 | - | - | - | - | - | |
| 9AA (50 µg) | Mean | - | - | - | - | - | - | 509.3 | - | - | - |
| MF | - | - | - | - | - | - | 63.67 | - | - | - | |
| MMS (2 µL) | Mean | - | - | - | - | - | - | - | - | 1037.3 | - |
| MF | - | - | - | - | - | - | - | - | 40.95 | - | |
NPD: 4-nitro-1,2-phenylene-diamine
9AA: 9-aminoacridine
2AA: 2-aminoanthracene
SA: sodium azide
MMS: methylmethanesulfonate
MF: mutation factor
Table 4: Summary of Experiment II (pre-incubation method)
| Concentrations (µg/plate) | Mean values of revertants / Mutation factor (MF) | Salmonella typhimuriumtester strains | Escherichia coli | ||||||||
| TA98 | TA100 | TA1535 | TA1537 | WP2uvrA | |||||||
| -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | ||
| Untreated control | Mean | 22.0 | 26.7 | 110.0 | 122.3 | 7.0 | 11.0 | 5.7 | 12.0 | 34.0 | 38.3 |
| MF | 1.10 | 1.10 | 1.47 | 1.22 | 0.72 | 1.10 | 0.81 | 1.24 | 1.00 | 1.02 | |
| Distilled water control | Mean | - | - | 119.0 | - | 7.0 | - | - | - | 44.3 | - |
| MF | - | - | 1.59 | - | 0.72 | - | - | - | 1.30 | - | |
| DMSO control |
Mean | 21.7 | 29.3 | - | 132.0 | - | 12.7 | 8.0 | 8.0 | - | 42.3 |
| MF | 1.08 | 1.21 | - | 1.31 | - | 1.27 | 1.14 | 0.83 | - | 1.12 | |
| DMF control |
Mean | 20.0 | 24.3 | 75.0 | 100.7 | 9.7 | 10.0 | 7.0 | 9.7 | 34.0 | 37.7 |
| MF | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 | |
| 5000 | Mean | 12.3 | 21.0 | 57.0 | 94.3 | 7.7 | 9.3 | 5.3 | 11.3 | 29.7 | 28.7 |
| MF | 0.62 | 0.86 | 0.76 | 0.94 | 0.79 | 0.93 | 0.76 | 1.17 | 0.87 | 0.76 | |
| 1581 | Mean | 18.0 | 21.3 | 81.0 | 99.7 | 6.7 | 6.7 | 5.3 | 8.7 | 20.3 | 32.0 |
| MF | 0.90 | 0.88 | 1.08 | 0.99 | 0.69 | 0.67 | 0.76 | 0.90 | 0.60 | 0.85 | |
| 500 | Mean | 14.3 | 20.3 | 76.3 | 99.7 | 7.7 | 9.0 | 8.0 | 8.0 | 30.0 | 30.3 |
| MF | 0.72 | 0.84 | 1.02 | 0.99 | 0.79 | 0.90 | 1.14 | 0.83 | 0.88 | 0.81 | |
| 158.1 | Mean | 16.7 | 18.0 | 52.0 | 91.3 | 6.0 | 8.0 | 2.0 | 6.3 | 31.0 | 35.0 |
| MF | 0.83 | 0.74 | 0.69 | 0.91 | 0.62 | 0.80 | 0.29 | 0.66 | 0.91 | 0.93 | |
| 50 | Mean | 10.7 | 24.3 | 83.0 | 93.0 | 4.3 | 7.7 | 2.7 | 9.3 | 22.3 | 36.3 |
| MF | 0.53 | 1.00 | 1.11 | 0.92 | 0.45 | 0.77 | 0.38 | 0.97 | 0.66 | 0.96 | |
| 15.81 | Mean | 16.0 | 23.7 | 58.3 | 101.3 | 7.0 | 10.3 | 5.7 | 7.3 | 27.0 | 36.7 |
| MF | 0.80 | 0.97 | 0.78 | 1.01 | 0.72 | 1.03 | 0.81 | 0.76 | 0.79 | 0.97 | |
| 5 | Mean | 14.7 | 17.7 | 80.7 | 91.0 | 5.3 | 7.3 | 6.3 | 7.7 | 24.3 | 32.3 |
| MF | 0.73 | 0.73 | 1.08 | 0.90 | 0.55 | 0.73 | 0.90 | 0.79 | 0.72 | 0.86 | |
| 1.581 | Mean | 15.3 | 23.7 | 63.3 | 97.0 | 5.3 | 7.3 | 7.0 | 5.7 | 23.0 | 32.7 |
| MF | 0.77 | 0.97 | 0.84 | 0.96 | 0.55 | 0.73 | 1.00 | 0.59 | 0.68 | 0.87 | |
| NPD (4 µg) | Mean | 298.7 | - | - | - | - | - | - | - | - | - |
| MF | 13.78 | - | - | - | - | - | - | - | - | - | |
| 2AA (2 µg) | Mean | - | 2374.7 | - | 2468.0 | - | 192.3 | - | 207.3 | - | - |
| MF | - | 80.95 | - | 18.70 | - | 15.18 | - | 25.92 | - | - | |
| 2AA (50 µg) | Mean | - | - | - | - | - | - | - | - | - | 235.3 |
| MF | - | - | - | - | - | - | - | - | - | 5.56 | |
| SAZ (2 µg) | Mean | - | - | 1202.7 | - | 1134.7 | - | - | - | - | - |
| MF | - | - | 10.11 | - | 162.10 | - | - | - | - | - | |
| 9AA (50 µg) | Mean | - | - | - | - | - | - | 364.0 | - | - | - |
| MF | - | - | - | - | - | - | 45.50 | - | - | - | |
| MMS (2 µL) | Mean | - | - | - | - | - | - | - | - | 1102.7 | - |
| MF | - | - | - | - | - | - | - | - | 24.87 | - | |
NPD: 4-nitro-1,2-phenylene-diamine
9AA: 9-aminoacridine
2AA: 2-aminoanthracene
SA: sodium azide
MMS: methylmethanesulfonate
MF: mutation factor
Moreover, a reliable chromosome aberration test with CAS 3687-45-4 and with CAS 93685-70-2 was available, respectively. Both tests revealed negative results.
CAS 3684-45-4: negative in Chinese hamster lung fibroblasts V79 cells with and without metabolic activation, tested up to precipitating concentrations
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for read across
Data on genetic toxicity in bacterial cells with docosyl stearate (CAS 22413-03-2) are available. However, data on in vitro studies on cytogenicity, and in vitro studies on gene mutation in mammalian cells of docosyl stearate (CAS 22413-03-2) were not available.
The assessment was therefore based on studies conducted with analogue substances as part of a read across approach, which is in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5. For each specific endpoint the source substance(s) structurally closest to the target substance is/are chosen for read-across, with due regard to the requirements of adequacy and reliability of the available data. Structural similarities and similarities in properties and/or activities of the source and target substance are the basis of read-across. A detailed justification for the analogue read-across approach is provided in the technical dossier (see IUCLID Section 13).
Genetic toxicity (mutagenicity) in bacteria in vitro
CAS 22413-03-2
The in vitro genetic toxicity of docosyl stearate (CAS 22413-03-2) was assessed in a bacterial reverse mutation study (Ames test), performed under GLP conditions according to OECD 471 (CiToxLab, 2012). S. typhimurium strains TA 1535, TA 1537, TA 98 and TA 100, and E. coli WP2 uvr A were exposed to the test substance at concentrations up to 5000 µg/plate. Precipitation or slight precipitation were observed in all tester strains at 1581 and 5000 µg/plate with and without metabolic activation. The negative and positive controls were valid. The test substance did not induce a significant increase in reversions in the S. typhimurium strains or E. coli strain, with or without metabolic activation.
Genetic toxicity (cytogenicity) in mammalian cells in vitro
CAS 3687-45-4
The potential of oleyl oleate (CAS 3687-45-4) to induce chromosomal aberrations was assessed using Chinese hamster lung fibroblast (V79) cells, in a GLP study performed according to OECD 473 (Cytotest Cell Research, 1994a). The V79-cells were exposed to oleyl oleate at concentrations up to 100 µg/mL, with and without metabolic activation (S9-mix). One experiment with duplicate replications was performed. A 4-hour treatment was performed without metabolic activation, using 10, 60 and 100 µg/mL concentration levels with 18-hour fixation time; and a 100 µg/mL concentration level with a 28-hour fixation time. The treatment with metabolic activation was performed at concentrations of 10, 60 and 100 µg/mL with an 18-hour treatment time, and 18-hour fixation time; and at 100 µg/mL with a 28-hour treatment time and 28-hour fixation time, respectively. Precipitation was observed at concentrations from 100 µg/mL, while no cytotoxicity was noted at any concentration. The negative and positive controls were valid.The test material did not induce a statistically significant increase in the frequency of cells with chromosome aberrations, with or without metabolic activation.
CAS 93803-87-3
The cytogenetic potential of 2-octyldodecyl isooctadecanoate (CAS 93803-87-3) was assessed in an in vitro mammalian chromosome aberration test in primary human lymphocytes, performed according to OECD 473 and under GLP conditions (Notox, 1998e). Duplicate cultures of cultured human peripheral lymphocytes were evaluated for chromosome aberrations in the presence and absence of metabolic activation. In the first experiment, cells were incubated with test substance concentrations of 100, 333 and 1000 µg/mL for 24 hours with a 24-hour fixation time and at 1000 µg/mL for 48 hours with a 48-hour fixation time, in the absence of a metabolic activation system. The first experiment was also performed with cells exposed to 100, 333 and 1000 µg/mL for 3 hours with a 24-hour fixation time, and at 1000 µg/mL for 3 hours with a 48-hour fixation time in the presence of metabolic activation. In the second experiment cells were incubated with 100, 333 and 1000 µg/mL for 24 hours followed by a 24-hour expression time, without metabolic activation. In the presence of metabolic activation cell were exposed to 100, 333 and 1000 µg/mL for 3 hours followed by a 24-hour expression time. No cytotoxicity was observed. At 1000 µg/mL, precipitation was observed in the culture medium. The vehicle and positive controls were valid. The test material did not induce a statistically significant increase in the frequency of cells with chromosome aberrations, with or without metabolic activation.
Genetic toxicity (mutagenicity) in mammalian cells in vitro
CAS 3687-45-4
An in vitro mammalian cell gene mutation assay was performed using oleyl oleate (CAS 3687-45-4), according to OECD 476 and under GLP conditions (Cytotest Cell Research, 1994b). Two separate experiments were performed. Chinese hamster lung fibroblast (V79) cells were treated with oleyl oleate at concentrations of up to 100 µg/mL for 4 hours, with and without metabolic activation. After an expression time of 7 days in growth medium, cells were incubated for 9 or 12 days with 6-thioguanine as selection agent for forward mutation at the HPRT locus. Precipitation was seen at concentrations of 100 µg/mL and higher. The positive and negative controls were valid and within the range of historical control data. No cytotoxicity was observed. No significant increase in mutation frequency was observed, with and without metabolic activation.
Overall conclusion for genetic toxicity
The results of the available in vitro studies were consistently negative. Based on the available data and following the analogue approach, no mutagenic or clastogenic potential in vitro is expected for docosyl stearate (CAS 22413-03-2).
Justification for classification or non-classification
According to Article 13 of Regulation (EC) No. 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of substances", information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met. Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. This avoids the need to test every substance for every endpoint". Since the analogue concept is applied to docosyl stearate (CAS 22413-03-2), data will be generated from data for reference source substance(s) to avoid unnecessary animal testing. Additionally, once the analogue read-across concept is applied, substances will be classified and labelled on this basis.
Therefore, based on the analogue read-across approach, the available data on genetic toxicity do not meet the classification criteria according to Regulation (EC) 1272/2008 and are therefore conclusive but not sufficient for classification.
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