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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 vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- yes
- Remarks:
- Cytotoxicity not evaluated (report not available)
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
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
Test animals
- Species:
- mouse
- Strain:
- other: BOR:NMRI
- Sex:
- male/female
Administration / exposure
- Route of administration:
- intraperitoneal
- Details on exposure:
- Three groups of 18 five-weeks old mice each were administered a single 10 ml/kg intraperitoneal injection of either EPTAC, physiological saline or
cyclophosphamide. The test material dose corresponded to 82.4 mg/kg and the positive control was 51.1 mg/kg. - Duration of treatment / exposure:
- 6 mice per sex and per control group and 7 mice of the treated group were killed 24, 48 and 72 hours after injection.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
82.4 mg/kg
Basis:
nominal conc.
- No. of animals per sex per dose:
- 6 mice/sex/control group and 7 mice/treated group
- Control animals:
- yes
- Positive control(s):
- Cyclophosphamide
- Route of administration: intraperitoneal
- Doses / concentrations: 51.1 mg/kg
Examinations
- Tissues and cell types examined:
- Bone marrow from mice of the treated and control groups was removed for erythrocyte analysis. For each sampling, five mice per sex and per group were used and 1000 polychromatic erythrocytes (PCE) were counted per animal.
- Evaluation criteria:
- The ratio of polychromatic to normochromatic (PCE/NCE) was used to assess the toxicity of the substance.
- Statistics:
- The PCE indices with micronuclei were statistically analysed by using a Poisson test on each treatment group, sex and both sexes combined.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- positive
- Toxicity:
- yes
- Remarks:
- slight to moderate clonic convulsions
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- In clinical examination, toxic symptoms, manifested as slight to moderate clonic convulsions, were observed in the EPTAC treated animals. At 72 h
there is a significant increase in the PCE/NCE in males. However, the authors of the report stated that the control values were exceptionally low based on intralaboratory and literature reported historical control incidences. The positive result of the males also caused a significant increase when both sexes were combined. On the other hand, at 24 h, there was a clear, statistically significant increase of micronucleated PCE in females. In males of
this sampling time, the number of PCEs was double the size than in respective negative controls with p-value of 0.076. The increase remained
significant even when both sexes were evaluated as one group.
Any other information on results incl. tables
Table 7.6.2 a PCEs with micronuclei scored in 1000 PCEs with PCE/NCE in control animals
PCE and PCE/NCE / animal Control group |
24h |
48h |
72h |
|||||||||
PCE (M) |
PCE/ NCE (M) |
PCE (F) |
PCE/ NCE (F) |
PCE (M) |
PCE/ NCE (M) |
PCE (F) |
PCE/ NCE (F) |
PCE (M) |
PCE/ NCE (M) |
PCE (F) |
PCE/ NCE (F) |
|
1 |
3 |
2.05 |
1 |
1.77 |
1 |
1.40 |
1 |
2.13 |
0 |
2.55 |
0 |
2.41 |
2 |
0 |
1.71 |
1 |
1.97 |
2 |
2.04 |
2 |
1.86 |
1 |
4.05 |
0 |
3.33 |
3 |
1 |
1.93 |
2 |
1.67 |
0 |
2.09 |
1 |
1.72 |
1 |
2.70 |
1 |
2.70 |
4 |
2 |
2.45 |
2 |
1.67 |
0 |
1.20 |
2 |
1.57 |
0 |
2.80 |
1 |
2.80 |
5 |
2 |
1.89 |
1 |
1.96 |
0 |
1.75 |
2 |
1.42 |
0 |
3.41 |
1 |
3.41 |
Mean |
1.6 |
1.4 |
0.6 |
1.6 |
0.4 |
0.6 |
Table 7.6.2 b PCEs with micronuclei scored in 1000 PCEs with PCE/NCE in EPTAC treated animals
PCE and PCE/NCE / animal 82.5 mg/kg EPTAC (i.p.) |
24h |
48h |
72h |
|||||||||
PCE (M) |
PCE/ NCE (M) |
PCE (F) |
PCE/ NCE (F) |
PCE (M) |
PCE/ NCE (M) |
PCE (F) |
PCE/ NCE (F) |
PCE (M) |
PCE/ NCE (M) |
PCE (F) |
PCE/ NCE (F) |
|
1 |
2 |
1.99 |
8 |
2.10 |
2 |
1.08 |
1 |
1.71 |
2 |
1.70 |
0 |
1.81 |
2 |
1 |
0.98 |
4 |
1.17 |
3 |
0.96 |
1 |
2.01 |
2 |
1.22 |
0 |
2.58 |
3 |
1 |
2.40 |
10 |
1.08 |
3 |
1.08 |
1 |
1.40 |
3 |
2.97 |
2 |
1.78 |
4 |
9 |
2.40 |
8 |
1.21 |
0 |
1.82 |
2 |
1.06 |
4 |
1.55 |
0 |
2.89 |
5 |
3 |
2.29 |
6 |
1.11 |
0 |
1.17 |
2 |
1.34 |
0 |
1.98 |
0 |
2.91 |
Mean |
3.2 |
7.2 |
1.6 |
1.6 |
2.2 |
0.4 |
Table 7.6.2 c Statistical evaluation of mouse micronucleus test
PCE with micronuclei/Group |
24h |
48h |
72h |
|||
M |
F |
M |
F |
M |
F |
|
EPTAC |
16 |
36 |
8 |
8 |
11 |
2 |
Negative control |
8 |
7 |
3 |
8 |
2 |
3 |
F |
1.7778 |
4.5000 |
2.000 |
0.8889 |
3.6667 |
0.5000 |
p-value |
0.076 |
0.000 |
0.113 |
0.589 |
0.011 |
0.812 |
Positive control |
154 |
138 |
94 |
29 |
35 |
19 |
Negative control
|
8 |
7 |
3 |
8 |
2 |
3 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): positive
Under the test conditions, EPTAC is considered as clastogenic in vivo (mouse). - Executive summary:
- In an in
vivo chromosome aberration test performed according to OECD guideline
No 474 and in compliance with GLP, mice (BOR:NMRI) were
exposed by intraperitoneal injection to EPTAC at a concentration of 82.5
mg/kg. Positive
controls induced the appropriate response.
There was a clear statistically significant increase of micronucleated PCE in males and females.
Under the test conditions, EPATC was clastogenic in mouse in vivo.
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