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EC number: 256-283-8 | CAS number: 46830-22-2
- 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:
- Start of the experimental phase December 13, 2013; Termination of the in-life phase January 13, 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented GLP guideline study on a well characterized test material.
Data source
Reference
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Benzyldimethyl[2-[(1-oxoallyl)oxy]ethyl]ammonium chloride
- EC Number:
- 256-283-8
- EC Name:
- Benzyldimethyl[2-[(1-oxoallyl)oxy]ethyl]ammonium chloride
- Cas Number:
- 46830-22-2
- Molecular formula:
- C14H20NO2.Cl
- IUPAC Name:
- benzyldimethyl[2-(prop-2-enoyloxy)ethyl]azanium chloride
- Reference substance name:
- Benzyldimethyl[2-[(1-oxoallyl)oxy]ethyl]-ammonium chloride
- IUPAC Name:
- Benzyldimethyl[2-[(1-oxoallyl)oxy]ethyl]-ammonium chloride
- Test material form:
- other: Colorless liquid
- Details on test material:
- - Name of test material (as cited in study report): Flocryl™ ADAM/BZCL 80%
- Substance type: Organic
- Physical state: Colorless liquid
- Analytical purity: Monomer concentration: 78.6%
- Impurities: Water (>21%)
- Composition of test material, percentage of components: 78.6
- Purity test date: 04.12.2013
- Lot/batch No.: ADBZ 5-47-13-14-D
- Expiration date of the lot/batch: not available
- Stability under test conditions: Stable
- Storage condition of test material: +10°C to +25°C
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Manfred Bauer Kaninchen, Lohe 7/1, 74632 Neuenstein,Germany
- Age at study initiation: Approx. 5 - 6 months
- Weight at study initiation: 3.8 - 3.9 kg
- Housing: For 8 hours following test item application, the animals were kept singly in restrainers which allowed free movement of the head but prevented a complete body turn, wiping of the eyes with the paws and excluded irritation of the eye by excrements and urine.
During the acclimatisation period and after the 8-hour period in restrainers, the animals were kept singly in cages with dimensions of 380 mm x 425 mm x 600 mm (manufacturer: Dipl.Ing. W. EHRET GmbH, 16352 Schönwalde, Germany).
- Diet (e.g. ad libitum): The food was available ad libitum before and after the exposure period.
- Water (e.g. ad libitum): Tap water was offered daily ad libitum.
- Acclimation period: At least 20 adaptation days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C (maximum range).
- Humidity (%): The relative humidity amounted to 30% - 70% (maximum range).
- Air changes (per hr): 15 to 20 times
- Photoperiod (hrs dark / hrs light): Rooms were lit (150 lux at approx 1.5 m room height) and darkened on a 12-hour light/12-hour dark cycle.
IN-LIFE DATES: From: December 01, 2014 To: Termination of the in-life phase January 13, 2014
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye served as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL of the test item were administered into one eye. The test item was placed into the conjunctival sac of the right eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second in order to prevent loss of the material. The left eye, which remained untreated, served as a control.
- Concentration (if solution):
VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity: - Duration of treatment / exposure:
- The test was performed initially using one animal. As no corrosive or severe irritant effects were observed in this animal, 2 further animals were employed 24 hours after start of the initial test.
Sixty minutes prior to test item administration, 0.01 mg Buprenovet®/kg b.w. were administered by subcutaneous injection to all animals to provide a therapeutic level of systemic analgesia to avoid or minimize pain and distress.
Five minutes prior to the test item administration, two drops of Ophtocain®, a topical anaesthetic, was applied to each eye of all animals, to the right eye, in which the test item was to be applied, and to the left eye, which served as control.
Eight hours after administration, Buprenovet 0.01 mg/kg, s.c. and Metacam 0.5 mg/kg, s.c. were administered to provide a continued therapeutic level of systemic analgesia. No washout after 24 hours was performed. - Observation period (in vivo):
- The eyes were examined ophthalmoscopically with a slit lamp prior to the administration and 1, 24, 48, 72 hours and 4 to 7 days after the administration. The eye reactions were observed and registered.
- Number of animals or in vitro replicates:
- 3 male animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Eight hours after administration, Buprenovet 0.01 mg/kg, s.c. and Metacam 0.5 mg/kg, s.c. were administered to provide a continued therapeutic level of systemic analgesia. No washout after 24 hours was performed.
- Time after start of exposure: Eight hours after administration
SCORING SYSTEM:
Reactions were scored according to the following scheme:
CORNEA
Opacity degree of density (area most dense taken for reading)
no ulceration or opacity 0
scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible 1
easily discernible translucent area, details of iris slightly obscured 2
nacreous areas, no details of iris visible, size of pupil barely discernible 3
opaque cornea, iris not discernible through the opacity 4
IRIS
normal 0
markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia, or injection, iris reactive to light (a sluggish reaction is considered to be an effect) 1
haemorrhage, gross destruction, or no reaction to light 2
CONJUNCTIVAE
Redness (refers to palpebral and bulbar conjunctivae, excluding cornea and iris)
normal 0
some blood vessels hyperaemic (injected) 1
diffuse, crimson colour; individual vessels not easily discernible 2
diffuse beefy red 3
CHEMOSIS
Swelling: refers to lids and/or nictitating membranes
normal 0
some swelling above normal 1
obvious swelling with partial eversion of lid 2
swelling with lids about half-closed 3
swelling with lids more than half-closed 4
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
One day before and 24 hours after administration, fluorescein was applied to the eyes before being examined to aid evaluation of the cornea for possible lesions. The fluorescein test was repeated on each day of observation. Fluorescein SE Thilo drops (ALCON PHARMA GmbH, 79108 Freiburg, Germany).
Fluorescein-Test:
DEGREE OF STAINING
no staining 0
scattered or diffuse colouration, details of iris clearly visible 1
easily discernible translucent area, details of iris slightly obscured 2
opalescent areas, details of iris not discernible, extent of pupil difficultly determinable 3
opaque cornea, iris not discernible through the opacity
INVOLVED AREA OF CORNEA
none 0
up to 1/4 of the surface 1
1/4 to 1/2 of the surface 2
1/2 to 3/4 of the surface 3
3/4 to whole surface. 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 60 minutes after instillation
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 hours to 5 days after instillation
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 6 days after instillation
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 7 days after instillation
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No observed effect
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: All time points
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No effect observed
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: All time points
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No effect observed
- Irritant / corrosive response data:
- The fluorescein tests revealed corneal staining in animal no. 2 (24 hours to 4 days after instillation, up to 1/4 of the surface).
In addition, lacrimation was observed in all animals 24 and 48 hours, in animal no. 1 until 6 days and in animal no. 2 until 4 days after instillation. - Other effects:
- There were no systemic intolerance reactions.
Any other information on results incl. tables
Time after |
C O R N E A |
I R I S |
C O N J U N C T I V A E |
F l u o r e s c e i n T e s t |
||
|
Opacity |
|
Redness# |
Chemosis## |
Grade |
Area |
|
Animal no. : 1 / 2 / 3 |
|||||
Right eye: 0.1 mLTest item/animal |
||||||
before dosing |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
60 minutes |
0/0/0 |
0/0/0 |
2/2/1 |
0/0/0 |
-/-/- |
-/-/- |
24 hours |
0/0/0 |
0/0/0 |
1a/2a/1a |
0/0/0 |
0/1/0 |
0/1/0 |
48 hours |
0/0/0 |
0/0/0 |
1a/1a/1a |
0/0/0 |
0/1/0 |
0/1/0 |
72 hours |
0/0/0 |
0/0/0 |
1a/1a/1 |
0/0/0 |
0/1/0 |
0/1/0 |
4 days |
0/0/0 |
0/0/0 |
1a/1a/1 |
0/0/0 |
0/1/0 |
0/1/0 |
5 days |
0/0/0 |
0/0/0 |
1a/1/1 |
0/0/0 |
0/0/0 |
0/0/0 |
6 days |
0/0/0 |
0/0/0 |
1a/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
7 days |
0/-/- |
0/-/- |
0/-/- |
0/-/- |
0/-/- |
0/-/- |
# refers to palpebral and bulbar conjunctivae; excluding cornea and iris
## swelling: refers to lids and/or nictitating membrane
a lacrimation
- no examination
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the study conditions, the substance was non- irritating to eyes
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