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EC number: 210-959-9 | CAS number: 626-67-5
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- (adopted 1983)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
- Version / remarks:
- (adopted 1983)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- (adopted 1997)
- Deviations:
- yes
- Remarks:
- 2-Aminoanthracene was the sole positive control in the presence of S9-Mix.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1-methylpiperidine
- EC Number:
- 210-959-9
- EC Name:
- 1-methylpiperidine
- Cas Number:
- 626-67-5
- Molecular formula:
- C6H13N
- IUPAC Name:
- 1-methylpiperidine
- Details on test material:
- - Name of test material (as cited in study report): 1-Methylpiperidin ca. 80% b. 100%
- Physical state: colorless liquid
- Analytical purity: 80.2%
- Lot/batch No.: Tank 73
- Stability: The stability of the test substance throughout the study period has been verified by reanalysis.
- Storage condition of test material: room temperature (under nitrogen conditions)
Constituent 1
Method
- Target gene:
- Salmonella: HIS
E. coli: TRP
Species / strain
- Species / strain / cell type:
- other: Salmonella typhimurium TA1535, TA100, TA1537, TA98, E. coli wp2 uvra
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix from Aroclor 1254 induced rat liver.
- Test concentrations with justification for top dose:
- First experiment, standard plate test:
TA1535, TA1537, TA100, TA98, E.coli: 25, 125, 625, 3125, 6250 µg/plate
Second experiment, standard plate test:
TA98, E. coli: 1000, 2000, 3000, 4000, 5000 µg/plate
Third experiment, preincubation test:
TA1535, TA1537, TA100, TA98, E.coli: 20, 100, 500, 2500, 5000 µg/plate - Vehicle / solvent:
- Water
Controls
- Untreated negative controls:
- yes
- Remarks:
- sterility control
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: With S9-mix: TA 100, TA 98, TA 1537 and TA 1535: 2.5 µg 2-AA; E. coli WP2 uvrA: 60 µg 2-AA; Without S9-mix: TA100, TA1535: 5 µg MNNG; TA98: 10 µg NOPD; TA1537: 100 µg AAC; E. coli WP2 uvrA: 10 µg ENNG
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation) and preincubation
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: background growth
Positive control:
with S-9 mix: 2.5 µg 2-aminoanthracene (2-AA, dissolved in DMSO) for the strains TA 100, TA 98, TA 1537 and TA 1535.
60 µg 2-aminoanthracene (2-AA, dissolved in DMSO) for the strain E. coli WP2 uvrA.
without S-9 mix: 5 µg N-methyl-N'-nitro-N-nitrosoguanidine (MNNG, dissolved in DMSO) for the strains TA 100 and TA 1535.
10 µg 4-nitro-o-phenylendiamine (NOPD, dissolved in DMSO) for the strain TA 98.
100 µg 9-aminoacridine (AAC) chloride monohydrate (dissolved in DMSO) for the strain TA 1537
10 µg N-ethyl-N'-nitro-N-nitrosoguanidin (ENNG, dissolved in DMSO) for the strain E. coli WP2 uvrA
S9-fraction:
At least 5 male Sprague-Dawley rats (200 - 300 g) receive a single intraperitoneal injection of 500 mg Aroclor 1254 per kg body weight 5 days before sacrifice. Five days after administration the rats are sacrificed, and the livers are prepared. The livers are weighed and washed in an equivalent volumne of a 150 mM KCl solution, then cut into small pieces and homogenized in three volumes of KCl solution. After centrifugation of the homogenate at 9000 x g for 10 minutes at +4°C, 5 mL portions of the supernatant (so-called S-9 fraction) are quickly deep-frozen in dry ice and stored at -700C° to -800C°.
S9-mix:
One volume of S-9 fraction is mixed with 9 volumes of S-9 supplement (cofactors). This preparation, the so-called S-9 mix, is kept on ice until used. The concentrations of the cofactors in the S-9 mix are: MgCl2 8 mM, KCl 33 mM, Glucose-6-phosphate 5 mM, NADP 4 mM, Phosphate buffer (pH 7.4) 15 mM
Standard plate test, Salmonella typhimurium:
Test tubes containing 2 mL portions of soft agar which consists of 100 mL agar (0.6% agar + 0.6% NaCl) and 10 mL amino acid solution (minimal amino acid solution for the determination af mutants: 0.5 mM histidine + 0.5 mM biotin) are kept in a water bath at 45°C, and the remaining components are added in the following order: 0.1 mL test solution or vehicle, 0.1 mL bacterial suspension, 0.5 mL S-9 mix (in tests with metabolic activation) or 0.5 mL phosphate buffer (in tests without metabolic activation). After mixing, the samples are poured onto Vogel-Bonner agar plates (minimal glucose agar plates) within approx. 30 seconds. Composition of the minimal glucose agar: 980 mL aqua dest., 20 mL Vogel-Bonner E medium, 15 g Difco bacto agar, 20 g D-glucose, monohydrate. After incubation at 37°C for 48 - 72 hours in the dark, the bacterial colonies (his revertants) are counted.
Standard plate test, E. coli:
Test tubes containing 2 mL portions of soft agar which consists of 100 mL agar (0.6% agar + 0.6% NaCl) and 10 mL amino acid solution (minimal amino acid solution for the determination of mutants: 0.5 mM tryptophan) are kept in a water bath at 45°C, and the remaining components are added in the following order: 0.1 mL test solution or vehicle 0.1 mL bacterial suspension, 0.5 mL S-9 mix (in tests with metabolic activation) or 0.5 mL phosphate buffer (in tests without metabolic activation). After mixing, the samples are poured onto Vogel-Bonner agar plates (minimal glucose agar plates) within approx. 30 seconds.
Preincubation test:
0.1 mL test solution or vehicle, 0.1 mL bacterial suspension and 0.5 mL S-9 mix are incubated at 37°C for the duration of 20 minutes. Subsequently, 2 mL of soft agar is added and, after mixing, the samples are poured onto the agar plates within approx. 30 seconds. After incubation at 37°C for 48-72 hours in the dark, the bacterial colonies are counted.
Titer determination:
In general, the titer is determined only in the experiments with S-9 mix both without test substance (vehicle only) and after adding the two highest amounts of substance. For this purpose, in the standard plate test 0.1 mL of the overnight cultures is diluted to 10xE-6 in each case. Test tubes containing 2 mL portions of soft agar containing maximal amino acid solution (5 mM tryptophan or 5 mM histidine + 0.5 mM biotin) are kept in a water bath at 45°C, and the remaining components are added in the following order: 0.1 mL vehicle (without and with test substance), 0.1 mL bacterial suspension (dilution: 10E-6), 0.5 mL S-9 mix.
In the preincubation test, 0.1 mL of the overnight cultures is diluted to 10E-6 in each case. 0.1 mL vehicle (with and without test substance), 0.1 mL bacterial suspension and 0.5 mL S-9 mix are incubated at 37°C for 20 minutes. Subsequently, 2 mL of soft agar containing maximal amino acid solution for titer determination (5 mM tryptophan or 5 mM histidine + 0.5 mM biotin) is added. After mixing, the samples are poured onto the agar plates within approx. 30 seconds. After incubation at 37°C for 48 hours in the dark, the bacterial colonies are counted. - Evaluation criteria:
- In general, a substance to be characterized as positive in the bacterial tests has to fulfill the following requirements:
- doubling of the spontaneous mutation rate (control)
- dose-response relationship
- reproducibility of the results
Results and discussion
Test results
- Species / strain:
- other: Salmonella typhimurium TA1535, TA100, TA1537, TA98,E. coli wp2 uvra
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- in the preincubation assay at doses > 2500 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: no test substance precipitation was found.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
A bacteriotoxic effect (reduced his or trp background growth, decrease in the number of his or trp revertants, reduction in the titer) was observed in the preincubation assay at doses > 2500 µg/plate. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: Number (arithmetic mean) of colonies of histidine and tryptophan-prototrophic back-mutants in experiments without microsomal activation in the standard plate test.
Concentration (µg/plate) |
TA98 |
TA100 |
TA1535 |
TA1537 |
E.coli WP2 uvrA |
Test substance |
|
|
|
|
|
0 |
27 |
137 |
18 |
12 |
29 |
25 |
24 |
134 |
19 |
10 |
30 |
125 |
30 |
133 |
19 |
9 |
28 |
625 |
27 |
121 |
17 |
7 |
34 |
3125 |
41 |
107 |
18 |
6 |
33 |
6250 |
29 |
114 |
16 |
7 |
32 |
|
|
|
|
|
|
MNNG |
|
|
|
|
|
5 |
|
1414 |
1842 |
|
|
AAC |
|
|
|
|
|
100 |
|
|
|
415 |
|
NOPD |
|
|
|
|
|
10 |
1038 |
|
|
|
|
ENNG |
|
|
|
|
|
10 |
|
|
|
|
565 |
Table 2: Number (arithmetic mean) of colonies of histidine and tryptophane-prototrophic back-mutants in experiments with microsomal activation in the standard plate test.
Concentration (µg/plate) |
TA98 |
TA100 |
TA1535 |
TA1537 |
E.coli WP2 uvrA |
Test substance |
|
|
|
|
|
0 |
33 |
125 |
16 |
13 |
32 |
25 |
35 |
137 |
17 |
7 |
36 |
125 |
37 |
128 |
15 |
8 |
42 |
625 |
32 |
142 |
12 |
5 |
42 |
3125 |
62 |
164 |
21 |
10 |
50 |
6250 |
49 |
132 |
19 |
12 |
40 |
|
|
|
|
|
|
2-AA |
|
|
|
|
|
60 |
|
|
|
|
225 |
2.5 |
621 |
1073 |
122 |
171 |
|
Table 3: Number (arithmetic mean) of colonies of histidine and tryptophan-prototrophic back-mutants in experiments without microsomal activation in the second standard plate test.
Concentration (µg/plate) |
TA98 |
E.coli WP2 uvrA |
Test substance |
|
|
0 |
26 |
32 |
1000 |
27 |
27 |
2000 |
31 |
31 |
3000 |
28 |
30 |
4000 |
25 |
27 |
5000 |
23 |
29 |
|
|
|
NOPD |
|
|
10 |
1138 |
|
ENNG |
|
|
10 |
|
504 |
Table 4: Number (arithmetic mean) of colonies of histidine and tryptophane-prototrophic back-mutants in experiments with microsomal activation in the second standard plate test.
Concentration (µg/plate) |
TA98 |
E.coli WP2 uvrA |
Test substance |
|
|
0 |
43 |
43 |
1000 |
33 |
42 |
2000 |
35 |
44 |
3000 |
38 |
42 |
4000 |
30 |
40 |
5000 |
28 |
42 |
|
|
|
2-AA |
|
|
60 |
|
248 |
2.5 |
798 |
|
Table 5: Number (arithmetic mean) of colonies of histidine and tryptophan-prototrophic back-mutants in experiments without microsomal activation in the preincubation test.
Concentration (µg/plate) |
TA98 |
TA100 |
TA1535 |
TA1537 |
E.coli WP2 uvrA |
Test substance |
|
|
|
|
|
0 |
30 |
132 |
24 |
11 |
32 |
20 |
29 |
130 |
21 |
10 |
32 |
100 |
29 |
135 |
20 |
8 |
29 |
500 |
35 |
136 |
19 |
9 |
25 |
2500 |
10 |
62 |
11 |
1 |
10 |
5000 |
0 (B) |
0 (B) |
0 (B) |
0 (B) |
0 (B) |
|
|
|
|
|
|
MNNG |
|
|
|
|
|
5 |
|
1122 |
1385 |
|
|
AAC |
|
|
|
|
|
100 |
|
|
|
412 |
|
NOPD |
|
|
|
|
|
10 |
1556 |
|
|
|
|
ENNG |
|
|
|
|
|
10 |
|
|
|
|
515 |
(B): reduced background growth
Table 6: Number (arithmetic mean) of colonies of histidine and tryptophane-prototrophic back-mutants in experiments with microsomal activation in the preincubation test.
Concentration (µg/plate) |
TA98 |
TA100 |
TA1535 |
TA1537 |
E.coli WP2 uvrA |
Test substance |
|
|
|
|
|
0 |
47 |
145 |
23 |
12 |
35 |
20 |
47 |
145 |
20 |
11 |
31 |
100 |
44 |
136 |
13 |
10 |
27 |
500 |
44 |
128 |
11 |
7 |
33 |
2500 |
38 |
146 |
8 |
8 |
24 |
5000 |
17 |
0 (B) |
0 (B) |
0 (B) |
10 |
|
|
|
|
|
|
2-AA |
|
|
|
|
|
60 |
|
|
|
|
202 |
2.5 |
759 |
1024 |
131 |
115 |
|
(B): reduced background growth
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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