Registration Dossier
Registration Dossier
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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.
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EC number: 204-662-3 | CAS number: 123-92-2
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: scientific article, published in scientific journal, details on tested material, methodology and results
Data source
Reference
- Reference Type:
- publication
- Title:
- Salmonella mutagenicity test. V. Results from testing of 311 chemicals.
- Author:
- Zeiger E, Anderson B, Haworth S, Lawlor T & Mortelmans K
- Year:
- 1 992
- Bibliographic source:
- Environ Mol Mutagen 19 (Suppl 21), 2 - 141
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Principles of method if other than guideline:
- NTP-protocol
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- isoamyl alcohol
- IUPAC Name:
- isoamyl alcohol
- Details on test material:
- - Name of test material (as stated in publication): isoamyl alcohol (Chemische Fabriek Naarden, Holl and)
- Physical state: clear, colourless liquid
- Analytical purity: 98%
- Impurities (identity and concentrations): arsenic, 3 ppm (max); copper and iron, 50 ppm (max); lead, 10 ppm (max) ; total heavy metals (as lead), 20 ppm (max) .
- Other: specific gravity (20°/20°C), 0-809-0-815 ; refractive index (20°C), 1-406-1-412; melting point, -117.2°C ; boi ling point, 132°C
Constituent 1
Method
- Target gene:
- his-gene
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 97
- Species / strain / cell type:
- S. typhimurium TA 1537
- Species / strain / cell type:
- S. typhimurium TA 1535
- Species / strain / cell type:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 fractions of Aroclor 1254-induced Sprague-Dawley rat and Syrian hamster livers
- Test concentrations with justification for top dose:
- 0 - 10000 microgram of test substance per plate
(at least 5 test concentrations; determination in triplicate) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: "The solvent of choice was disilled water, followed by dimethyl sulfoxide (DMSO), 95 % ethanol, and acetone."
Controlsopen allclose all
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- other: sodium azide (TA1535, TA100), 9-aminoacridine (TA97, TA1537), 4-nitro-o-phenylenediamine (TA98)
- Remarks:
- in tests without metabolic activation
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- in tests with metabolic activation
- Details on test system and experimental conditions:
- Method of application: preincubation
Duration:
preincubation period: 20 min
exposure duration: 48 h - Evaluation criteria:
- A chemical was judged mutagenic (+) or weakly mutagenic (+W) if it produced a reproducible, dose-related response over the solvent control, under a single metabolic activation condition , replicate trials. A chemical was judged questionable (?) if the results of individual trials were not reproducible, if increases in his+ revertants did not meet the criteria for a "W+" response, or if only single doses produced increases in his+ revertants in repeat trials. Chemicals were judged nonmutagenic (-) if they did not meet the criteria for a mutagenic or questionable response.
- Statistics:
- 5 test concentrations; determination in triplicate
Results and discussion
Test results
- Species / strain:
- other: Salmonella typhimurium TA 97, TA 98, TA 100, TA 1535, TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: yes, partly at the higher test concentrations (see results tables)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Summary of results:
negative (-). The substance was found to be not mutagenic.
Results in detail:
| HLI = hamster liver | ||
| RLI = rat liver | ||
| s = slight clearing of background lawn (slight toxicity at the highest test concentration(s)) | ||
| TA100 | |||||
| Dose | no activation | 10 % HLI | 30 % HLI | 10 % RLI | 30 % RLI |
| µg/plate | mean | mean | mean | mean | mean |
| 0.000 | 97 | 120 | 179 | 109 | 168 |
| 10.000 | ... | ||||
| 33.000 | ... | ||||
| 100.000 | ... | ... | ... | ... | ... |
| 333.000 | ... | ... | ... | ... | ... |
| 1000.000 | 85 | ... | ... | ... | ... |
| 1666.000 | |||||
| 3333.000 | ... | ... | ... | ... | |
| 6666.000 | 86 | ||||
| 10000.000 | 122 | 95 | 135 | ||
| pos. Control | 383 | 416 | 593 | 407 | 614 |
| TA1535 | |||||
| Dose | no activation | 10 % HLI | 30 % HLI | 10 % RLI | 30 % RLI |
| µg/plate | mean | mean | mean | mean | mean |
| 0.000 | 27 | 9 | 10 | 7 | 13 |
| 10.000 | ... | ||||
| 33.000 | ... | ... | ... | ||
| 100.000 | ... | ... | ... | ... | ... |
| 333.000 | ... | ... | ... | ... | ... |
| 1000.000 | 12 | ... | ... | ... | |
| 1666.000 | 6 | ... | |||
| 3333.000 | ... | ... | |||
| 6666.000 | 7 | 0s | |||
| 10000.000 | 0s | ||||
| pos. Control | 331 | 141 | 205 | 167 | 60 |
| TA97 | |||||
| Dose | no activation | 10 % HLI | 30 % HLI | 10 % RLI | 30 % RLI |
| µg/plate | mean | mean | mean | mean | mean |
| 0.000 | 172 | 171 | 212 | 197 | 205 |
| 10.000 | ... | ||||
| 33.000 | ... | ... | |||
| 100.000 | ... | ... | ... | ... | ... |
| 333.000 | ... | ... | ... | ... | ... |
| 1000.000 | 140s | ... | ... | ... | ... |
| 1666.000 | 184 | ||||
| 3333.000 | ... | ... | 142s | ||
| 6666.000 | 161 | ||||
| 10000.000 | 136s | 0s | |||
| pos. Control | 617 | 406 | 395 | 465 | 351 |
| TA98 | |||||
| Dose | no activation | 10 % HLI | 30 % HLI | 10 % RLI | 30 % RLI |
| µg/plate | mean | mean | mean | mean | mean |
| 0.000 | 19 | 30 | 33 | 33 | 48 |
| 10.000 | ... | ||||
| 33.000 | ... | ... | |||
| 100.000 | ... | ... | ... | ... | ... |
| 333.000 | ... | ... | ... | ... | ... |
| 1000.000 | 17 | ... | ... | ... | ... |
| 1666.000 | 31 | ||||
| 3333.000 | ... | 24 | 14s | ||
| 6666.000 | 23 | ||||
| 10000.000 | 0s | 0s | |||
| pos. Control | 447 | 416 | 364 | 404 | 134 |
| TA1537 | |||
| Dose | no activation | 30 % HLI | 30 % RLI |
| µg/plate | mean | mean | mean |
| 0.000 | 13 | 8 | 12 |
| 10.000 | |||
| 33.000 | ... | ||
| 100.000 | ... | ... | ... |
| 333.000 | ... | ... | ... |
| 1000.000 | 5 | ... | ... |
| 1666.000 | 1s | ||
| 3333.000 | 7 | ... | |
| 6666.000 | |||
| 10000.000 | 1s | 2s | |
| pos. Control | 241 | 56 | 42 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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