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EC number: 700-363-1 | CAS number: 1335203-20-7
- 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
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- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008-10-31 to 2008-11-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- (6E)-3,13-diethylpentadec-6-ene; (6E)-tetradec-6-ene; (7E)-hexadec-7-ene; (8E)-nonadec-8-ene; 2-[(6E)-3,13-diethylpentadec-6-en-8-yl]butanedioic acid; 2-[(8E)-nonadec-8-en-7-yl]butanedioic acid; 2-[(8E)-tetradec-8-en-7-yl]butanedioic acid; 2-[(9E)-hexadec-9-en-8-yl]butanedioic acid
- EC Number:
- 700-363-1
- Cas Number:
- 1335203-20-7
- IUPAC Name:
- (6E)-3,13-diethylpentadec-6-ene; (6E)-tetradec-6-ene; (7E)-hexadec-7-ene; (8E)-nonadec-8-ene; 2-[(6E)-3,13-diethylpentadec-6-en-8-yl]butanedioic acid; 2-[(8E)-nonadec-8-en-7-yl]butanedioic acid; 2-[(8E)-tetradec-8-en-7-yl]butanedioic acid; 2-[(9E)-hexadec-9-en-8-yl]butanedioic acid
- Details on test material:
- - Name of test material (as cited in study report): Hydrolysed reaction products of furan-2,5-dione and C15-18-(linear and branched)-alkenes
- Lot/batch No.: PO709-4739
Constituent 1
Method
- Target gene:
- Reversion to histidine independence in Salmonella typhimurium and reversion to tryptophan independence in Escherichia coli.
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli, other: WP2 uvrA-
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver homogenate (10% liver S9 in standard cofactors)
- Test concentrations with justification for top dose:
- A preliminary test was carried out to determine the toxicity of the test material, where 10 concentrations (0 - 5000 ug/plate) and a vehicle control were tested. For experiment 1, five concentrations of the test material (50, 150, 500, 1500 and 5000 ug/plate) were assayed in triplicate against each tester strain, using the direct plate incorporation method. A second experiment was performed using the same methodology and the test material dose range for experiment 1.
- Vehicle / solvent:
- 50 mg/ml Dimethyl formamide.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- dimethyl formamide
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- N-ethyl-N'-nitro-N-nitrosoguaniding (ENNG), 9-Aminoacridine (9AA), 4-Nitroquinoline-1-oxide (4NQO), 2-Aminoanthracene (2AA) and Benzo(a)pyrene (BP)
- Evaluation criteria:
- The assay may be considered valid if the following criteria are met:
All tester strain cultures exhibit a characteristic number of spontaneous revertants per plate in the vehicle and untreated controls.
The appropriate characteristics for each tester strain have been confirmed and all tester strain cultures should be in the range of 1 to 9.9 E+09 bacteria per ml.
Each mean positive control value should be at least twice the respective vehicle control value for each strain, thus demonstrating both the intrinsic sensitivity of the tester strains to mutagenic exposure and the integrity of the S9-mix.
There should be a minimum of 4 non-toxic test material dose levels and there should be no evidence of excessive contamination. - Statistics:
- Statistical methods as recommended by the UKEMS.
Results and discussion
Test results
- Key result
- 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 nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- A globular precipitate was observed at 5000 ug/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- other: Historical data from 2006-2007
- Positive controls validity:
- valid
Any other information on results incl. tables
The vehicle control plates gave counts of revertant colonies within the normal range. All of the positive control chemicals used in the test induced marked increases in the frequency of the revertant colonies, both with or without metabolic activation. Thus the sensitivity of the assay and the efficacy of the S9-mix were validated.
Table 1 - Test Results: Experiment 1- Without metabolic activation
Test Period |
From 10 November 2008 to 13 November 2008 |
||||||||||
Without S9-Mix |
Test Substance concentration (µg/plate) |
Number of revertants (mean number of colonies per plate) |
|||||||||
Base pair substitution type |
Frameshift type |
||||||||||
TA100 |
TA1535 |
WP2uvrA- |
TA98 |
TA1537 |
|||||||
- |
0 |
90 |
|
35 |
|
28 |
|
13 |
|
6 |
|
90 |
(88) |
32 |
(32) |
17 |
(25) |
12 |
(14) |
6 |
(7) |
||
83 |
4.0# |
28 |
3.5 |
30 |
7.0 |
16 |
2.1 |
8 |
1.2 |
||
- |
50 |
93 |
|
19 |
|
14 |
|
9 |
|
5 |
|
88 |
(83) |
28 |
(24) |
26 |
(20) |
18 |
(16) |
5 |
(5) |
||
67 |
13.8 |
25 |
4.6 |
20 |
6.0 |
20 |
5.9 |
6 |
0.6 |
||
- |
150 |
89 |
|
27 |
|
15 |
|
17 |
|
3 |
|
84 |
(82) |
29 |
(26) |
28 |
(21) |
16 |
(16) |
5 |
(3) |
||
73 |
8.2 |
21 |
4.2 |
20 |
6.6 |
15 |
1.0 |
2 |
1.5 |
||
- |
500 |
73 |
|
25 |
|
18 |
|
13 |
|
6 |
|
95 |
(84) |
18 |
(21) |
21 |
(18) |
13 |
(14) |
2 |
(3) |
||
84 |
11.0 |
20 |
3.6 |
14 |
3.5 |
15 |
1.2 |
2 |
2.3 |
||
- |
1500 |
89 |
|
24 |
|
17 |
|
17 |
|
5 |
|
80 |
(84) |
20 |
(23) |
17 |
(19) |
21 |
(17) |
2 |
(3) |
||
83 |
4.6 |
24 |
2.3 |
24 |
4.0 |
13 |
4.0 |
3 |
1.5 |
||
- |
5000 |
79 P |
|
16 P |
|
8 P |
|
12 P |
|
4 P |
|
67 P |
(76) |
15 P |
(14) |
14 P |
(13) |
10 P |
(11) |
3 P |
(4) |
||
83 P |
8.3 |
10 P |
3.2 |
18 P |
5.0 |
11 P |
1.0 |
5 P |
1.0 |
||
Positive controls S9-Mix - |
Name concentration (µg/plate) No. colonies per plate |
ENNG |
ENNG |
ENNG |
4NPQ |
9AA |
|||||
3 |
5 |
2 |
0.2 |
80 |
|||||||
336 |
|
89 |
|
182 |
|
108 |
|
1425 |
|
||
405 |
(362) |
111 |
(103) |
197 |
(182) |
114 |
(109) |
812 |
(975) |
||
346 |
37.3 |
109 |
12.2 |
167 |
15.0 |
105 |
4.6 |
687 |
395.0 |
P = precipitate, # = Standard deviation
Table 2 - Test Results: Experiment 1- With metabolic activation
Test Period |
From 10 November 2008 to 13 November 2008 |
||||||||||
With S9-Mix |
Test Substance concentration (µg/plate) |
Number of revertants (mean number of colonies per plate) |
|||||||||
Base pair substitution type |
Frameshift type |
||||||||||
TA100 |
TA1535 |
WP2uvrA- |
TA98 |
TA1537 |
|||||||
- |
0 |
85 |
|
22 |
|
16 |
|
10 |
|
5 |
|
87 |
(87) |
26 |
(22) |
22 |
(21) |
14 |
(13) |
5 |
(5) |
||
90 |
2.5# |
18 |
4.0 |
24 |
4.2 |
15 |
2.6 |
5 |
0.0 |
||
- |
50 |
90 |
|
32 |
|
20 |
|
11 |
|
7 |
|
88 |
(86) |
26 |
(27) |
16 |
(19) |
12 |
(11) |
6 |
(5) |
||
79 |
5.9 |
24 |
4.2 |
20 |
2.3 |
11 |
0.6 |
2 |
2.6 |
||
- |
150 |
82 |
|
25 |
|
9 |
|
9 |
|
3 |
|
90 |
(89) |
12 |
(19) |
16 |
(15) |
8 |
(8) |
3 |
(3) |
||
95 |
6.6 |
21 |
6.7 |
20 |
5.6 |
9 |
0.6 |
4 |
0.6 |
||
- |
500 |
91 |
|
16 |
|
12 |
|
15 |
|
3 |
|
78 |
(80) |
13 |
(16) |
16 |
(16) |
9 |
(11) |
4 |
(4) |
||
72 |
9.7 |
19 |
3.0 |
19 |
3.5 |
9 |
3.5 |
4 |
0.6 |
||
- |
1500 |
86 |
|
19 |
|
15 |
|
12 |
|
4 |
|
75 |
(78) |
17 |
(16) |
18 |
(17) |
10 |
(10) |
2 |
(3) |
||
73 |
7.0 |
13 |
3.1 |
17 |
1.5 |
9 |
1.5 |
4 |
1.2 |
||
- |
5000 |
81 P |
|
12 P |
|
15 P |
|
17 P |
|
3 P |
|
81 P |
(79) |
26 P |
(18) |
14 P |
(14) |
17 P |
(17) |
3 P |
(4) |
||
74 P |
4.0 |
16 P |
7.2 |
14 P |
0.6 |
17 P |
0.0 |
5 P |
1.2 |
||
Positive controls S9-Mix + |
Name concentration (µg/plate) No. colonies per plate |
2AA |
2AA |
2AA |
BP |
2AA |
|||||
1 |
2 |
10 |
5 |
2 |
|||||||
389 |
|
215 |
|
269 |
|
208 |
|
132 |
|
||
461 |
(428) |
244 |
(428) |
276 |
(237) |
196 |
(215) |
176 |
(175) |
||
433 |
36.3 |
252 |
19.5 |
272 |
3.5 |
240 |
22.7 |
217 |
42.5 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative with and without metabolic activation
No evidence of mutagenicity was seen under the conditions of this assay. The test material is considered to be non-mutagenic - Executive summary:
The mutagenicity of Hydrolysed reaction products of furan-2,5-dione and C15-18-(linear and branched)-alkenes was investigated in an Ames test (plate incorporation assay) using S. typhimurium strains TA98, TA100, TA1535 and TA1537 and Escherichia coli WP2uvrA-. Three replicate plates of each strain were exposed to the test material at concentrations of 50, 150, 500, 1500 and 5000 ug/plate in the presence and absence of an exogenous metabolic activation system (Rat liver homogenate (10% liver S9 in standard cofactors)). There was no evidence of cytotoxicity at the limit concentration; globular precipitation of the test material was seen at 5000 ug/plate. Exposure to the test material did not induce increased numbers of revertant colonies of any strain. Appropriate positive control compounds induced large increases in the numbers of revertant colonies, confirming the sensitivity of the assay. Results were confirmed in an independently-repeated assay. No evidence of mutagenicity was seen under the conditions of this study.
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