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EC number: 272-897-9 | CAS number: 68919-40-4
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 15 to 29 June 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Animals were observed until Day 7 instead of Day 21
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Imidazolium compounds, 1-[2-(2-carboxyethoxy)ethyl]-1(or 3)-(2-carboxyethyl)-4,5-dihydro-2-norcoco alkyl
- EC Number:
- 272-897-9
- EC Name:
- Imidazolium compounds, 1-[2-(2-carboxyethoxy)ethyl]-1(or 3)-(2-carboxyethyl)-4,5-dihydro-2-norcoco alkyl
- Cas Number:
- 68919-40-4
- Molecular formula:
- R_C8 H14 N2 O4 Na With R=Cn H2n+1 n=8, 10, 12, 14, 16, 18
- IUPAC Name:
- disodium 3-({2-[N-(2-hydroxyethyl)hexadecanamido]ethyl}amino)propanoate 3-[(2-hexadecanamidoethyl)(2-hydroxyethyl)amino]propanoate
- Test material form:
- liquid
1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: 8803149
- Expiration date of the lot/batch: not specified
- Purity test date: not specified
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals, Boyer town, PA.
- Age at study initiation: not specified (young animals)
- Weight at study initiation: 2.48 to 2.61 kg
- Housing: in suspended wire mesh cages
- Diet (e.g. ad libitum): purina rabbit pellets ad libitum
- Water (e.g. ad libitum): water at libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 5°C
- Humidity (%): not specified
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: 15 June 1988 To: 22 June 1988
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 sample of the test material was placed in the conjunctival sac of the right eye of each rabbit.
- Concentration (if solution): as such - Duration of treatment / exposure:
- single adminstration on Day 0
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: recording of grade of ocular lesions (cornea, iris, conjunctivae)
Pre-screening: All rabbits used in this study received a pre-screening examination designed to detec pre-exicsting ocular irritation or corneal change.
Dose application: A 0.1 mL of test material was placed in the conjunctival sac of the right eye of each rabbit. The left eye served as control and was not treated. The lids of the treated eye were gently held together for 1 second before releasing them to prevent loss of the test material.
Observation: The ocular reactions were graded at 24, 48, 72 hours and on Days 4 and 7 using the grading system as the one described in the OECD 405 guideline.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- On the basis of the results of this in vivo study in rabbit, the registered substance is considered a severe eye irritant (Eye Damage 1, H318) according to criteria of CLP and GHS UN.
- Executive summary:
The registered substance (product name = Miranol C2M AA) has been tested for acute ocular irritation in 3 New-Zealand White rabbits according to Draize test, and in compliance with Good Laboratory Practice. The test article, a liquid, was instillated as such in a single dose of 0.1 ml into the conjunctival sac of the right eye of the animal. The left eye remained untreated and served as a control. The eyes were not rinsed. Ocular examinations were performed at 24, 48, 72 hours after treatment, and at day 4 and 7.
Corneal opacity (score 2) was observed in all three rabbits at 24 hours. The reaction was still present in two animals at day 7 with grade 2, and with grade 1 in one animal. The mean scores (24-48-72 hours) calculated for each animal were 2.0 - 2.0 - 2.0. Iris reaction was observed between 24 hours and day 4 in one animal, and starting at day 3 in a second animal, whereas no reaction was observed in the third one. The mean scores (24-48-72 hours) calculated for each animal were 1.0 - 0.0 - 0.3.
Conjunctival redness (score 2 to 3) and chemosis (score 1 to 3) were observed and persisted until day 7 in all three animals. The mean scores (24-48-72 hours) calculated for each animal were 3.0 - 2.0 – 2.0 for redness, and 2.7 – 2.0 - 1.3 for chemosis.
In addition, ocular discharge was observed all three animals throughout the observation period.
On the basis of these results the registered substance is considered a severe eye irritant (Eye Damage 1, H318) according to criteria of CLP and GHS UN.
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