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EC number: 221-221-0 | CAS number: 3033-77-0
- 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:
- genetic toxicity in vitro
- Remarks:
- Type of genotoxicity: other: summary of differents in vitro studies
- Type of information:
- other: EU Risk Assessment report
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Although the EU risk assessment report is secondary literature, all data and risk assessment for the human, health and the environment have been evaluated and reviewed by Finland prior to publication. The risk assessment report has been submitted to final approval and published in the Official Journal of the European Union C157/10 dated on 21.06.2008. Thus, it is considered the information reported are reliable with the restrictions that reliability of the data presented has not been assessed again.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- European Union Risk Assessment 2,3-epoxypropyltrimethylammonium chloride CAS RN 3033-77-0 Einecs No: 221-221-0
- Author:
- EC
- Year:
- 2 008
- Bibliographic source:
- Risk Assessment. Final approved version. Rapporteur: Finland (FIN). European communities. Printed in Italy. 147pp
Materials and methods
Test material
- Reference substance name:
- 2,3-epoxypropyltrimethylammonium chloride
- EC Number:
- 221-221-0
- EC Name:
- 2,3-epoxypropyltrimethylammonium chloride
- Cas Number:
- 3033-77-0
- Molecular formula:
- C6H14NO.Cl
- IUPAC Name:
- N,N,N-trimethyl(oxiran-2-yl)methanaminium chloride
Constituent 1
Results and discussion
Any other information on results incl. tables
Table 7.6.1/1 Microbial mutagenicity tests with EPTAC.
Test system |
Concentrations (vehicle in parenthesis) |
Lowest effective dose, (S9 in parenthesis) |
Result |
Reference |
S. typhimuriumTA 1538 |
0.2, 2, 20, 100, 500, 2000 μg/plate +/- S9 (aq.)
|
n/a |
negative |
(Dean et al., 1978), (Dean et al., 1985)
|
S. typhimuriumTA 1535, 1537, 1538, 98, 100, rfa-, uvrB- (reverse mutation)
|
0, 1.58, 5, 15.8,50, 158, 500, 1580, 5000μg/plate +/- S9 (aq.)
|
n/a |
Positive |
(Degussa, 1984)
|
S. typhimuriumTA 100, 1535, 1537, 97, 98
|
0, 5, 10, 10, 50, 100 μg/plate, +/- S9 (aq.)
|
5μg/plate (5μg/plate) |
TA100 and 1535 positive at all concentrations with and without S9, (dose dependent)
|
(Vleminckx et al., 1987), (von der Hude et al., 1990b)
|
S. typhimuriumTA 1535, 1537, 1538, 98, 100
|
0, 2, 10, 50, 250, 1250, 6250μg/plate, +/- S9 (DMSO)
|
50μg/plate (250 μg/plate)
|
TA 1535, 1537 (dose dependent) and 100 (two highest doses) and with and without S9 positive (Doses not cytotoxic)
|
(Toxicol Laboratories, 1982)
|
Klebsiella pneumoniae (Luria Delbrück fluctuation test)
|
0 , 2, 5, 10 mmol/l +/- S9 (DMSO)
|
2 mmol/l (S9 n/a) |
Mutation rate incr. with increasing conc: 0, 0, 2.6, 4.4, 7.4
|
(Voogd et al., 1981)
|
E. coli WP2, E. Coli WP2 uvrA, S. typhimurium, S. cerevisiae
|
0, 2, 20, 100, 500, 2000 μg/plate +/- S9 (aq.)
|
20μg/plate (uvrA), (20 μg/plate (uvrA))
|
Positive in both strains of E. Coliwith and without S9
|
(Dean et al., 1978), (Dean et al., 1985)
|
E. coli PQ37 SOS chromotest
|
0, 3.3, 10.0, 100.0 mmol/l, +/- S9 (aq.)
|
SOS inducing potency ~0.5
|
Positive |
(von der Hude et al., 1990b)
|
S. cerevisiae JD1 induction of gene conversion (trp & his locus)
|
0, 0.1, 0.5, 1.0, 5.0, 10.0 μg/ml for 1h @ 37 °C + 16h @ 29°C, +/- S9 (aq.)
|
0.5 mg/ml (his), (0.5 mg/ml), 1 mg/ml (trp), (1 mg/ml)
|
Positive with and without S9
|
(Dean et al., 1978), (Dean et al., 1985)
|
S. cerevisiaeD7 induction of gene
|
0, 0.01, 0.05, 0.10, 0.50, 1.00, 5.00 mg/ml for 1h
|
0.5 mg/ml (0.5 mg/ml) |
Positive: Gene conversion increased
|
(Vleminckx et al., 1987)
|
Table 7.6.1/2 Mutagenicity tests with EPTAC in mammalian cells in vitro
Test system |
Concentrations |
Result |
Reference |
PRIMARY RAT HEPATOCYTE UDS |
0, 2, 20, 200 μMOL/L, FOR 20H @ 37 °C |
POSITIVE CELL COUNT VARIED FROM 15 TO 100 % IN THE TREATED CELLS. AT 20μMOL EPTAC WAS UDS POSITIVE (>50% POS. CELLS + NET GRAIN COUNT HIGHER THAN 2X SD OF CONTROL) |
(von der Hude et al., 1990a) |
CHINESE HAMSTER OVARY (CHO) CELLS |
0, 5, 10, 20, 50 AND 100 μG/ML OF EPTAC FOR 18 HOURS |
FREQUENCY OF ABERRATIONS, WITH OR WITHOUT GAPS, PER CELL AND THE PERCENTAGE OF CELLS WITH ALL ABERRATIONS INCREASED WITH THE DOSE |
(Vleminckx et al., 1987) |
SCE IN CHINESE HAMSTER V79 |
0, 0.125, 0.25, 0,5, 1.0, 2.0 MMOL/L |
POSITIVE STARTING FROM 0.25 MMOL/L, DOSE DEPENDENT INCREASE, R=0.87, S=7.1 |
(von der Hude et al., 1991) |
CHROMOSOME ASSAY IN RL1 CELL LINE |
0, 10, 0, 40, 80 μG/ML |
POSITIVE: DOSE RELATED INCREASE OF CHROMATID GAPS |
(Dean et al., 1978), (Dean et al., 1985) |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive
Based on the several in vitro genotoxicity studies performed, it could be conclude that EPTAC is a mutagen according to the criteria of the Annex I
of the CLP Regulation (EC) N° 1272/2008. - Executive summary:
EPTAC causes mutations in E. coli WP2 and S. typhimurium 1535, 1537 and 100 but not in 1538 or 98. These mutations did not require metabolic activation to occur. The evidence from the bacterial mutagenicity tests suggests that EPTAC acts as a direct point mutagen by base pair substitution but not frame shift mutation. In addition, tests in two yeast strains have demonstrated that EPTAC can cause gene conversion in two different gene loci.
The positive response in the liver UDS test gives indications of increased DNA damage in mammalian cells as well.
In addition, a well-correlated dose-related increase of sister chromatid exchanges in the Chinese hamster V79 cells was seen.
Damage to chromosomes has been shown to occur in mammalian test systems in vitro. The results of the in vitro chromosome aberration tests in both rat liver cells and Hamster ovary cells showed that both the frequency of aberrations per cell, with or without gaps, and the percentage of cells with all aberrations increased with the dose.
Positive in vitro results show that in addition to causing point mutations in bacterial systems, EPTAC has clastogenic or aneugenic potential in mammalian cells as well.
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