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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- other: EU Risk Assessment report
- 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:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye 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 / tissue source
- Species:
- rabbit
- Strain:
- other: Albino
- Details on test animals or tissues and environmental conditions:
- no detail
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): no data
VEHICLE
not applicable - Duration of treatment / exposure:
- the test substance was instilled and not rinsed. The scoring was performed at 1; 24; 48 and 72 hrs after the beginning of the treatment.
- Observation period (in vivo):
- within 21 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not applicable as no rinsing is done.
- Time after start of exposure: not applicable
SCORING SYSTEM: draize scale
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: no data
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- Mean individual score
- Time point:
- other: Overall 24, 48 and 72 hrs
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- Mean individual score
- Time point:
- other: Overall 24, 48 and 72 hrs
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- Mean individual score
- Time point:
- other: Overall 24, 48 and 72 hrs
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- Mean individual score
- Time point:
- other: Overall 24, 48 and 72 hrs
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- other: in one animal, congestion of the iris is irreversible
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- Mean individual score
- Time point:
- other: Overall 24, 48 and 72 hrs
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- other: In one animal, congestion of the iris was irreversible
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- Mean individual score
- Time point:
- other: Overall 24, 48 and 72 hrs
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- other: In one animal, congestion of the iris was irreversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- Mean individual score
- Time point:
- other: Overall 24, 48 and 72 hrs
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- Mean individual score
- Time point:
- other: Overall 24, 48 and 72 hrs
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- Mean individual score
- Time point:
- other: Overall 24, 48 and 72 hrs
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- Mean individual score
- Time point:
- other: Overall 24, 48 and 72 hrs
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- Mean individual score
- Time point:
- other: Overall 24, 48 and 72 hrs
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- Mean individual score
- Time point:
- other: Overall 24, 48 and 72 hrs
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not specified
- Irritant / corrosive response data:
- See details in table 7.3.2/1. In one animal, congestion of the iris persisted after the 21 day observation period. There was no detail on the reversibility of the other analysed parameters (cornea, conjunctivae and chemosis)
- Other effects:
- no data.
Any other information on results incl. tables
Table 7.3.2/1: Scores obtained after an instillation of EPTAC into the right conjunctival sac of the 3 rabbits.
Score at time point |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
24 h |
2/1/1 |
2/2/2 |
3/3/3 |
2/1/3 |
48 h |
1/1/1 |
2/1/2 |
3/3/3 |
3/2/3 |
72 h |
2/1/1 |
2/1/2 |
3/3/3 |
3/2/3 |
Average 24h, 48h, 72h |
1.7/1.0/1.0 |
2.0/1.3/2.0 |
3.0/3.0/3.0 |
2.7/1.7/3.0 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, the test substance is classified as Eye Dam. 1 (H318, Causes serious eye damage) according to the CLP regulation (No. 1272/2008) and as Risk of serious damage to eyes (Xi, R41) according to the Directive 67/548/EEC.
- Executive summary:
In an eye irritation study (Degussa, 1986a) performed according to the OECD guideline No. 405 protocol, 0.1 mL of a commercial solution (referred as QUAB 151) of 2,3-epoxypropyltrimethyl ammonium chloride (purity assumed to be 70-75%) (EPTAC) was instilled into the conjunctival sac of the right eye of three albino rabbits. No rinsing was performed. Cornea, iris and conjunctiva was examined and scored qualitatively and quantitatively after 1, 24, 48 and 72 hours. The rabbits were then observed for 21 days. EPTAC was severely irritating to eyes considering the scores obtained for the iris lesion (> 1.5). Furthermore, the effect on iris was persistent within 21 days in one animal which is also a criterion to classify the test substance as severe irritating to eyes.
Therefore, under the test conditions, EPTAC is classified as Eye Dam. 1 (H318, Causes serious eye damage) according to the CLP regulation (No. 1272/2008) and as Risk of serious damage to eyes (Xi, R41) according to the Directive 67/548/EEC.
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