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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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990-10-15 to 1990-10-18
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was conducted according to the appropriate OECD test guideline, with acceptable limitations, which were that only one dose was administered and only 1000 erythrocytes examined to determine the PCE/NCE ratio It was conducted in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- Version / remarks:
- 1984
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Automatically generated during migration to IUCLID 6, no data available
- IUPAC Name:
- Automatically generated during migration to IUCLID 6, no data available
- Details on test material:
- Quab 151, 88 %
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: BOR: NMRI (SPF Han)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Versuchtstierzucht GmbH &Co.KG., D-4799 Borchen
- Age at study initiation: 5 weeks
- Weight at study initiation: males 29-35 g, females 23-31 g
- Assigned to test groups randomly: yes
- Fasting period before study: 16 hours
- Housing: Macrolon cages, type II, 1 animal per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 55
- Air changes (per hr): no information
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- - Vehicle(s)/solvent(s) used: water
- Justification for choice of solvent/vehicle: none given in report
- Concentration of test material in vehicle: not stated - Duration of treatment / exposure:
- Single treatment
- Frequency of treatment:
- Single treatment
- Post exposure period:
- sampling at 24, 48 and 72 hours
Doses / concentrations
- Remarks:
- Doses / Concentrations:
82.5 mg/kg
Basis:
- No. of animals per sex per dose:
- 6 (control group) 7 (test group)
- Control animals:
- other: physiological saline
- Positive control(s):
- - cyclophosphamide
- Justification for choice of positive control(s): none given in report
- Route of administration: oral by gavage
- Doses / concentrations: 51.1 mg/kg bw
Examinations
- Tissues and cell types examined:
- bone marrow
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: based po toxicity study
DETAILS OF SLIDE PREPARATION:
air dried, stained with panoptic stain method developed by Pappenheim
METHOD OF ANALYSIS: 1000 PCE s scored under microscope (magnification 650-1000 x) for incidence of PCEs with micronuclei. Ratio of PCE to NCE was calculated based on 1000 erythrocytes.
- Evaluation criteria:
- A substance producing clear statistically significant positive response at all three test points is considered mutagenic.
- Statistics:
- Poisson test was applied
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- positive
- Toxicity:
- yes
- Remarks:
- slight to moderate clonic convulsions (all animals)
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
No statistically significant increase in micronucleated PCEs observed in males and females at 48 hours.
No statistically significant increase in micronucleated PCEs observed in males at 24 hour or in females at 72 hours.
No statistically significant increase in micronucleated PCEs observed in females at 72 hours.
Statistically significant increase in micronucleated PCEs observed in males at 72 hours due to exceptionally low negative control value.
At 24 hours a clear statistically significant increase in micronucleated PCEs was observed in females (p=0.000)
At 24 hours a statistically significant increase in micronucleated PCEs was observed in females (p=0.076)
When these values are combined the positive result is clearly statistically significant (p=0.000)
The test was not repeated to confirm this result because of the nature of the test material, and other positive results (not described in report).
Table 1 Results of in vivo micronucleus test (5 animals/sex, 1000 cells evaluated per animal) 24 hour sampling time
Sampling time |
Treatment |
Male/female |
PCE with MN |
Ratio PCE/NCE* |
24 hours |
Negative Control |
male |
1.6 ± 1.14 |
1.71-2.45 |
female |
1.4 ± 0.55 |
1.67-1.97 |
||
Test substance |
male |
3.2 ± 3.35 |
0.98-2.40 |
|
female |
7.2 ± 2.28 |
1.08-2.10 |
||
Positive control |
male |
30.8 ± 13.66 |
1.70-2.24 |
|
female |
27.6 ± 4.45 |
0.90-1.82 |
Table 2 Results of in vivo micronucleus test (5 animals/sex, 1000 cells evaluated per animal) 48 hour sampling time
Sampling time |
Treatment |
Male/female |
PCE with MN |
Ratio PCE/NCE* |
48 hours |
Negative Control |
male |
0.6 ± 0.89 |
1.20-2.09 |
female |
1.6 ± 0.55 |
1.42-2.13 |
||
Test substance |
male |
1.6 ± 1.52 |
0.96-1.82 |
|
female |
1.6 ± 0.89 |
1.06-2.01 |
||
Positive control |
male |
18.8 ± 3.77 |
0.32-0.62 |
|
female |
5.8 ± 2.77 |
0.75-1.19 |
Table 3 Results of in vivo micronucleus test (5 animals/sex, 1000 cells evaluated per animal) 72 hour sampling time
Sampling time |
Treatment |
Male/female |
PCE with MN |
Ratio PCE/NCE* |
72 hours |
Negative Control |
male |
0.4 ± 0.55 |
2.55-4.05 |
female |
0.6 ±0.55 |
1.78-3.47 |
||
Test substance |
male |
2.2 ± 1.48 |
1.22-2.97 |
|
female |
0.4 ± 0.89 |
1.78-2.91 |
||
Positive control |
male |
7.0 ± 1.73 |
0.16-0.46 |
|
female |
3.8 ± 1.3 |
0.34-1.31 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): positive
2,3-epoxypropyltrimethylammonium chloride has been tested in a valid study according to OECD 474 and under GLP. A statistically significant increase (p=0.000) in micronucleated PCEs was observed relative to the control at 24 hours (female, and both sexes combined). It is concluded that the test substance is positive for the induction of micronuclei under the conditions of the test.
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