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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- other: EU Risk Assessment
- Adequacy of study:
- other information
- Study period:
- No data
- 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-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other 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:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- not specified
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
- Details on test material:
- - Name of test material (as cited in study report): commercial preparation of EPTAC (QUAB 151)
- Analytical purity: varies between 70 and 75%
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Albino
- Details on test animals or test system and environmental conditions:
- no detail
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: intact or abraded skin
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 70-75%
VEHICLE
no data - Duration of treatment / exposure:
- 4h
- Observation period:
- 1; 24; 48; 72 hours after the treatment
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: The sample was instilled on 4 separate shaved locations of the back of animals. One side of the back, the skin was abraded while the other remained intact.
- % coverage: no data
- Type of wrap if used: occlusive (no more detail)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: no data
SCORING SYSTEM:
Results and discussion
In vivo
- Irritant / corrosive response data:
- At all time observation points (1; 24; 48 and 72 hrs), all individual scores were 0.00 for the intact aeras treated with EPTAC.
- Other effects:
- No data
Any other information on results incl. tables
No other information
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, the test item is not classified as irritating to skin according to the criteria of the CLP regulation (No. 1272/2008) and of the Directive 67/548/EEC.
- Executive summary:
In a skin irritation study (Degussa, 1985), considered as a Key study and performed similarly to the OECD guideline No. 404, three albino rabbits were exposed to 0.5 mL of the commercial preparation of 2,3-Epoxypropyltrimetylammonium Chloride (EPTAC) (referred as QUAB 151) for 4h under occlusive patch. The concentration was assumed varying between 70 and 75%.
The test sample was instilled on four separate shaved locations. One side of the back the skin was abraded while the other remained intact. For the calculation of irritation index, the scores from the intact areas were included only. The scoring was done within 1, 24, 48 and 72 hours after the end of the treatment. All the individual scores of the non-abraded skin treated with EPTAC were zero at all time points.
Another study was available (Degussa, 1981c) where the irritating properties of 2,3-epoxypropyltrimethyl ammonium chloride at 72% were investigated on 12 albino rabbits. On six rabbits, 0.5 mL of the test substance was instilled on an intact clipped area which was covered with a 1 sq. inch patch. Another group of six rabbits received the 0.5 mL of the substance on a skin area with slight abrasions to the stratum cornea, again covered with a patch wrapped with adhesive tape. Exposure time was 24 hours. Draize-scoring was used to calculate the irritation index at 24 and 72 hours after application on intact and abraded skin. The skin irritation effects were described as severe. They included well-defined erythema, slight ischemia, haemorrhages and slight to distinct incrustation and slight to moderate oedema. The average 24-h score on intact skin was 4.3 and 3.8 after 72 h and for abraded skin 6.3 both at 48 and at 72 hours. However, these positive results (evidence of a skin irritation) were obtained with worst case experimental conditions such as occlusive patch method and an exposure duration of 24h instead of a 4h exposure under semi-occlusive conditions according to the requirements of the current OECD guideline. Therefore, the results of this study are not considered to be relevant to draw a conclusion on skin irritation of EPTAC.
In conclusion, considering the results obtained in the Key study, the test item is not classified as irritating to skin according to the criteria of the CLP regulation (No. 1272/2008) and of the Directive 67/548/EEC.
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