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EC number: 233-226-5 | CAS number: 10094-45-8
- Life Cycle description
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- Endpoint summary
- Appearance / physical state / colour
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- Endpoint summary
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
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- Repeated dose toxicity
- Genetic toxicity
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- Additional toxicological data

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:
- guideline study with acceptable restrictions
- Remarks:
- GLP guideline study with acceptable restrictions. Although 5 strains were tested no strain for detection of cross-linking or oxidising mutagens was included.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- Strain for detection of oxidising or cross-linking mutagens is missing, but in accordance with guideline at the time of testing.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- (Z)-N-octadecyldocos-13-enamide
- EC Number:
- 233-226-5
- EC Name:
- (Z)-N-octadecyldocos-13-enamide
- Cas Number:
- 10094-45-8
- Molecular formula:
- C40H79NO
- IUPAC Name:
- (Z)-N-octadecyldocos-13-enamide
- Reference substance name:
- stearyl erucamide
- IUPAC Name:
- stearyl erucamide
Constituent 1
Constituent 2
Method
- Target gene:
- His-operon
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 1535, TA 1537, TA 1538, TA 98, TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat liver S-9
- Test concentrations with justification for top dose:
- 50, 150, 500, 1500, 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: hexane
- Justification for choice of solvent/vehicle: solubility of test compound in vehicle
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- hexane
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA 1537 without S-9 Migrated to IUCLID6: 80 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- hexane
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- TA 100 and TA 1535 without S-9 Migrated to IUCLID6: 3 µg/plate (TA 100), 5 µg/plate (TA 1535)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- hexane
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA 98 and TA 1538 without S-9 Migrated to IUCLID6: 1 µg/plate (TA 98) and 2 µg/plate (TA 1538)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- hexane
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene: 0.5 µg/plate with TA 1538 and TA 98, 1 µg/plate with TA 100, and 2 µg/plate with TA 1535 and TA 1537.
- Remarks:
- all strains with S-9
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 3 days
NUMBER OF REPLICATIONS: triplicates; independent repetition of complete test
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth; other: reduction of background growth - Evaluation criteria:
- Positive: increase in revertant colony numbers of at least twice of those of the concurrent solvent controls, with some evidence of a positive dose-relationship, in two separate experiments, with any bacterial strain either in presence or absence of S9-mix. No statistical analysis is performed.
Negative: no reproducible increases in revertant colony numbers of at least 1.5 times of those of the concurrent solvent controls, at any dose level with any bacterial strain. No statistical analysis is performed.
Ambiguous: If the results fail to satisfy the criteria for a clear positive or negative response as described the following approach is taken: 1) Repeat tests with modified experimental method may be performed. These modifications include (but are not restricted to) the use of a narrower dose range than that already tested; the use of different levels of liver homogenate S-9 fraction in the S-9 mix. Should an increase in revertant colony numbers be observed which satisfies the 'positive' criteria the material is considered to be mutagenic. No statistical analysis is performed. 2) If no clear 'positive' response can be obtained the test data may be subjected to analysis to determine the statistical significance of any observed increases in revertant colony numbers. The statistical procedure used is normally analysis of variance followed by Student's t-test. - Statistics:
- In case of ambiguous results analysis of variance followed by Student's t-test is performed. In case of unequivocally positive or negative results according to the described criteria, no statistical analysis is performed.
Results and discussion
Test resultsopen allclose all
- 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:
- Precipitation starting at 1500 µg/plate in test 1 and at 5000 µg/plate in test 2.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- 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:
- Precipitation starting at 1500 µg/plate in test 1 and at 5000 µg/plate in test 2.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- 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:
- Precipitation starting at 1500 µg/plate in test 1 and at 5000 µg/plate in test 2.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- 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:
- Precipitation starting at 1500 µg/plate in test 1 and at 5000 µg/plate in test 2.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Remarks:
- Precipitation starting at 1500 µg/plate in test 1 and at 5000 µg/plate in test 2.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Starting at 1500 µg/plate with and without metabolic activation in all strains in test 1 and at 5000 µg/plate with and without activation in all strains in test 2.
RANGE-FINDING/SCREENING STUDIES:
Dose range finding tests were performed with 5, 50, 500 and 5000 µg/plate. No cytotoxicity was observed, therefore 5000 µg/plate was chosen as maximum concentration for main test.
ADDITIONAL INFORMATION ON CYTOTOXICITY: No cytotoxicity was observed.
Any other information on results incl. tables
Maximum mean number of revertants (Test with highest revertant numbers chosen):
|
Mean revertant numbers ±SD |
|||
|
without S-9 |
with S-9 |
||
Strain |
Solvent control |
Test substance (µg/plate) |
Solvent control |
Test substance (µg/plate) |
TA 1535 |
10±2.6 |
11±3.1 (150) |
13±1.5 |
13±3.0 (50) |
TA 1537 |
12±2.5 |
11±2.6 (150) |
9±1.4 |
11±2.0 (50) |
TA 1538 |
11±1.5 |
11±1.5 (500) |
10±1.7 |
15±1.5 (500) |
TA 98 |
23±1.2 |
25±2.0 (500) |
23±3.6 |
24±0.6 (500) |
TA 100 |
75±5.1 |
87±6.1 (150) |
93±5.5 |
90±9.1 (5000) |
The concurrent positive controls demonstrated the validity of the test system.
No substantial increases in revertant colony numbers of any of the tester strains were observed following treatment with the test substance at any dose level, neither in the presence nor absence of metabolic activation.
Conclusion:
Under the conditions chosen the test substance was not mutagenic in bacteria.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
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