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EC number: 226-073-0 | CAS number: 5261-99-4
- 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 06 December 2012 to 04 February 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline and EU method. GLP study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
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:
- [(±)-(4-amino-2-hydroxy-4-oxobutyl)trimethylammonium] chloride
- EC Number:
- 226-073-0
- EC Name:
- [(±)-(4-amino-2-hydroxy-4-oxobutyl)trimethylammonium] chloride
- Cas Number:
- 5261-99-4
- Molecular formula:
- C7H17N2O2.Cl
- IUPAC Name:
- 4-amino-2-hydroxy-N,N,N-trimethyl-4-oxobutan-1-aminium chloride
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Physical state: white powder
- Analytical purity: 99,4%
- Lot/batch No.: WI 2274
- Storage condition of test material: at room temperature not exceeding 40°C.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Institute of Occupational Medicine, Łódź
- Age at study initiation: The experiment was conducted on three females which were 5.5 months old.
- Weight at study initiation: 4.2-4.7 kg
- Housing: The animals were kept individually in metal cages with the following dimensions: 60 x 35 x 40 cm (length x width x height).
- Diet (e.g. ad libitum): LSK standard granulated laboratory fodder, ad libitum
- Water (e.g. ad libitum): drinking tap water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21°C
- Humidity (%): 30 – 65%
- Air changes (per hr): about 16 times/hour
- Photoperiod (hrs dark / hrs light): 12 hours light – 12 hours dark
IN-LIFE DATES: From: 12 December 2012 To: 24 December 2012
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The test item (grounded to a powder) in a volume of 0.1 mL (0.049 g) was administered to the conjunctival sac of one eye of the animal by gently pulling the lower eyelid away from the eyeball. - Observation period (in vivo):
- 1, 24, 48 and 72 hours as well as 7 days after the administration of the test item.
- Number of animals or in vitro replicates:
- Three females
- Details on study design:
- SCORING SYSTEM:
Cornea
Opacity: degree of density (readings should be taken from most dense area) *
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 area, no details of iris visible, size of pupil barely discernible 3
Opaque cornea, iris not discernible through the opacity 4
Maximum possible: 4 * The area of corneal opacity should be noted
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
Hemorrhage, gross destruction, or no reaction to light 2
Maximum possible: 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
Maximum possible: 3
Chemosis
Swelling (refers to lids and/or nictitating membranes)
Normal 0
Some swelling above normal 1
Obvious swelling, with partial eversion of lids 2
Swelling, with lids about half closed 3
Swelling, with lids more than half closed 4
Maximum possible: 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24-72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24-72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24-72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24-72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24-72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24-72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24-72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24-72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24-72 h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24-72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24-72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24-72 h
- Score:
- 0
- Irritant / corrosive response data:
- After the administration of the test item, some pathological changes were observed in the conjunctivas of the animals’ eyes. No pathological changes were stated in the cornea and iris.
During the reading which took place 1 hour after the administration of the test item, congestion of the nictitating membrane was observed in three animals. Moreover, erythema in the form of congestion (injection) of some blood vessels and circumcorneal injection were stated in animals no. 2 and 3. Swelling of the nictitating membrane was observed in animal no. 2.
During the reading which took place 24 hours after the administration of the test item, congestion of the nictitating membrane was observed in animals no. 2 and 3. Moreover, circumcorneal injection was stated in animal no. 2. No conjunctival edema was observed.
During the reading which took place 48 hours after the administration of the test item, congestion of the nictitating membrane was observed in animals no. 2 and 3.
During the reading which took place 72 hours after the administration of the test item, congestion of the nictitating membrane was observed in animal no. 2.
During the reading which took place 7 days after the administration of the test item, no pathological changes were observed in rabbit no. 2.
Any other information on results incl. tables
Table 1: Eye irritation scores
Animal |
Region of eye |
24 h |
48 h |
72 h |
7 d |
1 |
Cornea
|
0 |
0 |
0 |
- |
Iris
|
0 |
0 |
0 |
- |
|
Conjunctivae erythema |
0 |
0 |
0 |
- |
|
Conjunctivae swelling |
0 |
0 |
0 |
- |
|
2 |
Cornea
|
0 |
0 |
0 |
0 |
Iris
|
0 |
0 |
0 |
0 |
|
Conjunctivae erythema |
1 |
1 |
1 |
0 |
|
Conjunctivae swelling |
0 |
0 |
0 |
0 |
|
3 |
Cornea
|
0 |
0 |
0 |
- |
Iris
|
0 |
0 |
0 |
- |
|
Conjunctivae erythema |
1 |
1 |
0 |
- |
|
Conjunctivae swelling |
0 |
0 |
0 |
- |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the available results, the test substance is not classified as eye irritating.
- Executive summary:
The acute eye irritation/corrosion study, according to the OECD Guideline No. 405 / EU Method B.5., was performed in order to obtain information on health hazards likely to arise from possible contact of the test item. The study started with a preliminary study on one animal. The test item was grounded to a powder and administered to the conjunctival sac of one eye of the animal (rabbit no. 1). Its volume was 0.1 mL. The second eye served as a control. After the evaluation of the treated eye, the test item was applied to the eyes of the next two animals (rabbit no. 2 and 3). General clinical observations of the animals for morbidity and mortality were performed daily during the entire experiment. Detailed clinical observations for changes in the cornea, iris and conjunctiva were performed 1, 24, 48 and 72 hours (all animals) as well as 7 days (rabbit no. 2) after the administration of the test item. The animals’ body weight was determined on the administration day (day 0) and on the last day of the experiment. After the administration of the test item, some pathological changes were observed in the conjunctivas of the animals’ eyes. No pathological changes were stated in the cornea and iris. Based on the available results, the test substance is not classified as eye irritating.
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