Registration Dossier
Registration Dossier
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EC number: 208-008-8 | CAS number: 505-32-8
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: Guideline study with acceptable restrictions. Restrictions: only 4 Sallmonella strains tested.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- only 4 salmonelly strains tested
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 3,7,11,15-tetramethylhexadec-1-en-3-ol
- EC Number:
- 208-008-8
- EC Name:
- 3,7,11,15-tetramethylhexadec-1-en-3-ol
- Cas Number:
- 505-32-8
- Molecular formula:
- C20H40O
- IUPAC Name:
- 3,7,11,15-tetramethylhexadec-1-en-3-ol
- Details on test material:
- - Name of test material (as cited in study report): Isophytol, test substance no.: 88/600
- Physical state: not reported
- Analytical purity: 97.6 %
- Impurities (identity and concentrations): not reported
Constituent 1
Method
- Target gene:
- histidine operon
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-treated rat liver S9
- Test concentrations with justification for top dose:
- 20, 100, 500, 2500, 5000 µg/plate (SPT and PIT, ± S9)
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
- Justification for choice of solvent/vehicle: test substance completely soluble in water
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: N-methyl-N'-nitro-N-nitrosoguanidine (MNNG, in DMSO), 5 µg/plate
- Remarks:
- TA100 and TA1535 without S9
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylendiamine (in DMSO), 10 µg/plate
- Remarks:
- TA98 without S9
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA1537 without S9
Migrated to IUCLID6: 100 µg/plate, (in DMSO)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene (in DMSO), 10 µg/plate
- Remarks:
- all strains with S9
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation) and preincubation
DURATION
- Preincubation period: 20 min at 37°C (preincubation test)
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS: triplicate plates
DETERMINATION OF CYTOTOXICITY
- Method: reduced his- background growth - Evaluation criteria:
- Positive: doubling of spontaneous mutation rate compared to control, dose-response relationship, reproducibility of the results.
Results and discussion
Test results
- 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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- 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
Maximum number of revertants (SPT):
| Control (mean ± SD) | Test substance (mean ± SD) (conc.) | |||
| Strain | -S9 | +S9 | -S9 | +S9 |
| TA100 | 111 ± 11 | 111 ± 13 | 121 ± 8 (20 µg) | 133 ± 14 (2500 µg) |
| TA98 | 31 ± 3 | 43 ± 2 | 29 ± 9 (500 µg) | 47 ± 5 (5000 µg) |
| TA1535 | 25 ± 2 | 23 ± 3 | 17 ± 3 (5000 µg) | 21 ± 2 (100 µg) |
| TA1537 | 8 ± 2 | 10 ± 2 | 8 ± 2 (2500 µg) | 11 ± 1 (2500 µg) |
Maximum number of revertants (PIT):
| Control (mean ± SD) | Test substance (mean ± SD) (conc.) | |||
| Strain | -S9 | +S9 | -S9 | +S9 |
| TA1535 | 29 ± 5 | 23 ± 6 | 28 ± 3 (20 µg) | 26 ± 2 (20 µg) |
| TA100 | 103 ± 4 | 118 ± 11 | 120 ± 11 (500 µg) | 113 ± 8 (20 µg) |
| TA1537 | 9 ± 3 | 11 ± 2 | 10 ± 2 (5000 µg) | 14 ± 4 (100 µg) |
| TA98 | 28 ± 5 | 47 ± 2 | 29 ± 9 (500 µg) | 44 ± 3 (5000 µg) |
Applicant's summary and conclusion
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