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EC number: 264-092-6 | CAS number: 63310-16-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- 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
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- 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
- Study period:
- 5 November 1982 to 18 November 1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guidelines and the study was conducted under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 9-Octadecenoic acid (Z)-, monoester with 1,2,3-propanetriol ester with boric acid (H3BO3)
- EC Number:
- 264-092-6
- EC Name:
- 9-Octadecenoic acid (Z)-, monoester with 1,2,3-propanetriol ester with boric acid (H3BO3)
- Cas Number:
- 63310-16-7
- Molecular formula:
- C21H39O5B (based on the representative structure below)
- IUPAC Name:
- 2-hydroxy-3-{[hydroxy({2-hydroxy-3-[(9Z)-octadec-9-enoyloxy]propoxy})boranyl]oxy}propyl (9Z)-octadec-9-enoate; 3-{[bis({2-hydroxy-3-[(9Z)-octadec-9-enoyloxy]propoxy})boranyl]oxy}-2-hydroxypropyl (9Z)-octadec-9-enoate; {2-hydroxy-3-[(9Z)-octadec-9-enoyloxy]propoxy}boronic acid
- Test material form:
- not specified
- Details on test material:
- - Physical state: liquid
Constituent 1
Method
- Target gene:
- Histidine synthesis
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 1538
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 0.1, 0.3, 1.0, 3.0 and 10.0 mg/plate both in the presence and absence of metabolic activation
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation). Top agar containing the test material, bacteria, and in some cases S9 mix was mixed and uniformly distributed over the surface of a minimal agar plate. Prior to testing, the molten top agar was prepared by adding 9 x 10^-5 mmoles each of L-histidine and D-biotin. 0.5 mL S9 mix (or S9 buffer) was then added to the number of aliquots of one strain required for one concentration, followed by 0.1 mL of the appropriate concentration of the test substance preparation. Finally 2 mL top agar was then added to each aliquot (2.5 mL for tests without S9 mix), and the resulting mixture poured onto the surface of a prepared pre-labelled plate.
DURATION
- Exposure duration: Plates were incubated inverted at 37 °C for two to three days
NUMBER OF REPLICATIONS: Test concentrations were performed in triplicate
- EVALUATION PROCEDURE: Following the total incubation the number of revertant colonies was counted and the presence and condition of the bacterial lawn was noted. - Evaluation criteria:
- Criteria for response in the Ames test are outlined in the field "Any other information on materials and methods incl. tables" section.
Results and discussion
Test resultsopen allclose all
- 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:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
The test material was checked for toxicity on strain TA100 without S9 mix at dose levels of 0.005 to 10 mg/plate. The plates were run in duplicate. No toxicity was observed at these dose levels and so it was decided to test concentrations of test material from 0.1 to 10.0 mg/plate in the definitive study. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: Results (Mean values of triplicate plates)
Treatment |
Amount/plate |
No. revertant colonies per plate |
||||||||||
TA98 |
TA100 |
TA1535 |
TA1537 |
TA1538 |
||||||||
without S9 |
with S9 |
without S9 |
with S9 |
without S9 |
with S9 |
without S9 |
with S9 |
without S9 |
with S9 |
|||
Test material |
10.0 mg |
16 |
35 |
85 |
118 |
25 |
15 |
15 |
18 |
14 |
20 |
|
3.0 mg |
25 |
32 |
86 |
102 |
24 |
11 |
16 |
19 |
14 |
23 |
||
1.0 mg |
14 |
36 |
94 |
100 |
26 |
14 |
14 |
18 |
16 |
24 |
||
0.3 mg |
22 |
32 |
113 |
103 |
25 |
13 |
15 |
22 |
21 |
23 |
||
0.1 mg |
22 |
32 |
88 |
85 |
30 |
10 |
18 |
19 |
14 |
23 |
||
DMSO |
0.1 mL |
19 |
33 |
90 |
90 |
23 |
14 |
21 |
20 |
13 |
23 |
|
Positive control |
2-nitrofluorene (10 µg) |
2-aminoanthracene (2 µg) |
sodium azide (1 µg) |
2-aminoanthracene (2 µg) |
sodium azide (1 µg) |
2-aminoanthracene (2 µg) |
9-aminoacridine (50 µg) |
2-aminoanthracene (2 µg) |
2-nitrofluorene (10 µg) |
2-aminoanthracene (2 µg) |
||
1964 |
3765 |
781 |
3605 |
589 |
254 |
1300 |
385 |
3928 |
4256 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Under the specific conditions of this assay, the test material gave a negative (i.e. non-mutagenic), response in Salmonella typhimurium strains TA1535, TA1537, TA1538, TA98 and TA100 both in the presence and absence of metabolic activation. No toxicity was observed. The tester strains responded to the positive controls, known mutagens, as expected, confirming the validity of the test method employed. The study is considered to be reliable, relevant and adequate for risk assessment and classification and labelling purposes. - Executive summary:
The potential of the test material to cause gene mutation in bacterial strains was determined following a methodology equivalent to standardised guideline OECD 471. Five strains of Salmonella typhimurium (TA1535, TA1537, TA1538, TA98 and TA100) were treated in the presence and absence of a rat liver derived metabolic activation system (S9 mix). Under the conditions of the study, the test material did not induce any significant, reproducible increases in the observed number of revertant colonies in any of the tester strains used either in the presence or absence of metabolic activation. No toxicity was observed. The tester strains responded to the positive controls, known mutagens, as expected, confirming the validity of the test method employed.
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