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EC number: 942-376-7 | CAS number: -
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 Oct - 18 Nov 2009
- 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- (1997)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- (Commission Regulation (EC) No 440/2008, May 2008)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hess. Ministerium für Umwelt, Energie, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction mass of 5,9-Undecadienal-2,6,10-trimethyl-, (5E)- and 5,9-Undecadienal-2,6,10-trimethyl-, (5Z)-
- EC Number:
- 942-376-7
- Molecular formula:
- C14H24O
- IUPAC Name:
- Reaction mass of 5,9-Undecadienal-2,6,10-trimethyl-, (5E)- and 5,9-Undecadienal-2,6,10-trimethyl-, (5Z)-
Constituent 1
Method
- Target gene:
- his operon (for S. typhimurium strains)
trp operon (for E. coli strain)
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Phenobarbital/β-Naphthoflavone
- Test concentrations with justification for top dose:
- Pre-experiment: 3, 10, 33, 100, 333 1000, 2500 and 5000 µg/plate
The pre-experiment is reported as Experiment 1.
Experiment 2: 1, 3, 10, 33, 100, 333, 1000, 2500 and 5000 µg/plate - Vehicle / solvent:
- - Vehicle/solvent used: DMSO
- Justification for choice of solvent/vehicle: The solvent was chosen because of its solubility properties and its relative non-toxicity to the bacteria.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylene-diamine (4-NOPD); 2-aminoanthracene (2-AA)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation) for experiment 1; preincubation for experiment 2
DURATION
- Preincubation period: 60 min at 37 °C
- Exposure duration: at least 48 h
NUMBER OF REPLICATIONS: in triplicates in 2 independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: reduction in the number of spontaneous revertants or a clearing of the bacterial background lawn - Rationale for test conditions:
- The test conditions were chosen according to OECD 471.
- Evaluation criteria:
- A test item is considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA 98, TA 100, and WP2 uvr A) or thrice (strains TA 1535 and TA 1537) the colony count of the corresponding solvent control is observed. A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration. An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment. A dose dependent increase in the number of revertant colonies below the threshold is
regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative and solvent controls such an increase is not considered biologically relevant. - Statistics:
- Mean values and standard deviations were calculated.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Exp. 1: +/-S9: starting at 333 µg/plate; Exp. 2: -S9: starting at 100 µg/plate, +S9: starting at 1000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Exp. 1: +/-S9: starting at 333 µg/plate; Exp. 2: -S9: starting at 100 µg/plate, +S9: starting at 1000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Exp. 1: +/-S9: starting at 333 µg/plate; Exp. 2: -S9: starting at 333 µg/plate, +S9: starting at 1000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Exp. 1: -S9: starting at 33 µg/plate, +S9: starting at 333 µg/plate; Exp. 2: -S9: starting at 100 µg/plate; +S9: 1000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Exp. 1: -S9: at 5000 µg/plate, +S9: starting at 2500 µg/plate; Exp. 2: +/-S9: starting at 1000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Precipitation of the test item was observed in the overlay agar in the test tubes from 1000 µg/plate up to 5000 µg/plate in the presence of metabolic activation in experiment 1 and with and without metabolic activation in experiment 2. Precipitation of the test item on the incubated agar plates were observed from 1000 µg/plate up to 5000 µg/plate in experiment 1 and from 2500 µg/plate up to 5000 µg/plate in experiment 2. The undissolved particles had no influence on the data recording.
RANGE-FINDING/SCREENING STUDIES: The pre-experiment is reported as Experiment I (all strains were tested in the pre-experiment).
HISTORICAL CONTROL DATA: Solvent, negative and positive control were within the range of historical control data.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
The plates incubated with the test item showed reduced background growth in all strains with and without metabolic activation in both independent experiments. Toxic effects, evident as a reduction in the number of revertants (below the indication factor of 0.5), occurred in the test groups.
Any other information on results incl. tables
Table 1. Test results of experiment 1
EXPERIMENT 1 (plate incubation method) |
|||||
S9-Mix |
Without
|
||||
Test substance (µg/plate) |
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvr A |
SC |
13 ± 3 |
14 ± 1 |
36 ± 2 |
36 ± 2 |
51 ± 11 |
NC |
12 ± 2 |
13 ± 3 |
30 ± 5 |
30 ± 5 |
41 ± 3 |
3 |
11 ± 3 |
14 ± 1 |
37 ± 4 |
37 ± 4 |
47 ± 10 |
10 |
12 ± 4 |
12 ± 0 |
33 ± 5 |
33 ± 5 |
44 ± 10 |
33 |
14 ± 1 |
14 ± 1 |
32 ± 5 |
32 ± 5 |
38 ± 6 |
100 |
14 ± 2 |
11 ± 2 |
23 ± 7 |
23 ± 7 |
38 ± 3 |
333 |
11 ± 2 R |
6 ± 1 R |
18 ± 1 |
18 ± 1 R |
38 ± 5 |
1000 |
6 ± 1 R, P |
4 ± 1 R, P |
16 ± 2 |
16 ± 2 R, P |
46 ± 3 P |
2500 |
3 ± 1 R, P |
4 ± 1 R, P |
16 ± 3 |
16 ± 3 R, P |
37 ± 7 P |
5000 |
0 ± 0 R, P |
5 ± 3 R, P |
17 ± 3 |
17 ± 3 R, P |
24 ± 4 P, R |
NaN3 |
1813 ± 78 |
|
|
1945 ± 41 |
|
4-NOPD |
|
79 ± 1 |
306 ± 31 |
|
|
MMS |
|
|
|
|
1025 ± 68 |
S9-Mix |
With
|
||||
Test substance (µg/plate) |
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvr A |
SC |
17 ± 5 |
15 ± 5 |
39 ± 4 |
136 ± 10 |
51 ± 9 |
NC |
15 ± 0 |
16 ± 4 |
39 ± 10 |
126 ± 27 |
48 ± 12 |
3 |
16 ± 2 |
16 ± 1 |
37 ± 7 |
122 ± 5 |
49 ± 8 |
10 |
15 ± 1 |
16 ± 1 |
40 ± 6 |
136 ± 14 |
49 ± 4 |
33 |
15 ± 5 |
16 ± 1 |
35 ± 10 |
155 ± 4 |
54 ± 6 |
100 |
16 ± 3 |
13 ± 4 |
37 ± 3 |
158 ± 3 |
55 ± 3 |
333 |
11 ± 1 R |
7 ± 1 R |
20 ± 2 R |
84 ± 9 R |
46 ± 3 |
1000 |
9 ± 1 R, P |
5 ± 2 R, P |
26 ± 3 R, P |
59 ± 7 R, P |
39 ± 4 P |
2500 |
6 ± 3 R, P |
4 ± 1 R, P |
15 ± 4 R, P |
58 ± 8 R, P |
24 ± 4 R, P |
5000 |
5 ± 3 R, P |
4 ± 1 R, P |
15 ± 4 R, P |
46 ± 4 R, P |
23 ± 5 R, P |
2-AA |
296 ± 12 |
|
2317 ± 83 |
2225 ± 10 |
206 ± 12 |
SC = Solvent Control (DMSO) NC = Negative Control (untreated) R = Reduced background growth P = Precipitate NaN3: sodium azide; 4-NOPD:4-nitro-o-phenylene-diamine; MMS: methylmethanesulfonate; 2-AA: 2-aminoanthracene |
Table 2. Test results of experiment 2
EXPERIMENT 2 (pre-incubation method) |
|||||
S9-Mix |
Without
|
||||
Test substance (µg/plate) |
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvr A |
SC |
14 ± 6 |
15 ± 3 |
21 ± 2 |
92 ± 23 |
44 ± 5 |
NC |
13 ± 1 |
17 ± 6 |
29 ± 1 |
132 ± 27 |
50 ± 3 |
1 |
11 ± 3 |
13 ± 2 |
28 ± 2 |
101 ± 6 |
47 ± 5 |
3 |
14 ± 2 |
12 ± 3 |
23 ± 4 |
88 ± 5 |
42 ± 13 |
10 |
16 ± 8 |
14 ± 2 |
24 ± 5 |
88 ± 15 |
48 ± 7 |
33 |
13 ± 4 |
8 ± 1 |
26 ± 6 |
97 ± 15 |
57 ± 13 |
100 |
10 ± 5 R |
10 ± 3 R |
24 ± 6 |
56 ± 12 R |
44 ± 7 |
333 |
10 ± 3 R |
8 ± 1 R |
22 ± 2 R |
42 ± 9 R |
44 ± 5 |
1000 |
3 ± 5 R |
3 ± 2 R |
20 ± 4 R |
43 ± 6 R |
39 ± 8 R |
2500 |
2 ± 4 R, P |
3 ± 2 R, P |
11 ± 2 R, P |
35 ± 7 R, P |
36 ± 6 R, P |
5000 |
1 ± 1 P, R |
1 ± 1 R, P |
8 ± 1 R, P |
1 ± 2 R, P |
42 ± 2 R, P |
NaN3 |
1605 ± 40 |
|
|
1755 ± 60 |
|
4-NOPD |
|
89 ± 5 |
385 ± 18 |
|
|
MMS |
|
|
|
|
583 ± 8 |
S9-Mix |
With
|
||||
Test substance (µg/plate) |
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvr A |
SC |
19 ± 6 |
21 ± 8 |
46 ± 5 |
115 ± 17 |
57 ± 11 |
NC |
20 ± 6 |
22 ± 5 |
33 ± 2 |
113 ± 10 |
57 ± 2 |
1 |
24 ± 3 |
32 ± 2 |
37 ± 3 |
111 ± 4 |
67 ± 7 |
3 |
17 ± 4 |
20 ± 4 |
39 ± 10 |
113 ± 7 |
59 ± 3 |
10 |
19 ± 4 |
17 ± 4 |
48 ± 6 |
120 ± 8 |
62 ± 7 |
33 |
23 ± 2 |
18 ± 2 |
42 ± 5 |
109 ± 6 |
69 ± 7 |
100 |
18 ± 6 |
22 ± 1 |
43 ± 14 |
107 ± 12 |
64 ± 4 |
333 |
23 ± 11 |
20 ± 6 |
29 ± 2 |
96 ± 9 |
57 ± 9 |
1000 |
6 ± 2 R |
1 ± 2 R |
26 ± 2 R |
23 ± 3 R |
33 ± 8 R |
2500 |
7 ± 6 R, P |
2 ± 2 R, P |
21 ± 4 R, P |
26 ± 1 R, P |
20 ± 4 R, P |
5000 |
7 ± 3 R, P |
1 ± 1 R, P |
19 ± 2 R, P |
30 ± 4 R |
25 ± 23 R, P |
2-AA |
286 ± 17 |
189 ± 15 |
1603 ± 86 |
1508 ± 434 |
394 ± 20 |
SC = Solvent Control (DMSO) NC = Negative Control (untreated) R = Reduced background growth P = Precipitate NaN3: sodium azide; 4-NOPD:4-nitro-o-phenylene-diamine; MMS: methylmethanesulfonate; 2-AA: 2-aminoanthracene |
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the Ames test the test substance was not mutagenic in any of the five strains (TA 1535, TA 1537, TA 98, TA 100 and WP2 uvr A) tested with and without metabolic activation up to 5000 µg/plate.
- Executive summary:
A bacterial gene mutation assay with the test substance was performed in accordance with OECD Guideline 471 and in compliance with GLP (2009). In this study the substance was not mutagenic in any of the five strains (TA 1535, TA 1537, TA 98, TA 100 and WP2 uvr A) tested with and without metabolic activation up to 5000 µg/plate.Precipitation was observed at concentrations ≥ 1000 µg/plate.
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