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EC number: 240-539-0 | CAS number: 16484-77-8
- 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:
- 24 January 1990 to 22 March 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- Version / remarks:
- 1984
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- (R)-2-(4-chloro-2-methylphenoxy)propionic acid
- EC Number:
- 240-539-0
- EC Name:
- (R)-2-(4-chloro-2-methylphenoxy)propionic acid
- Cas Number:
- 16484-77-8
- Molecular formula:
- C10H11ClO3
- IUPAC Name:
- (R)-2-(4-chloro-2-methylphenoxy)propionic acid
- Test material form:
- solid: flakes
- Remarks:
- Brown coloured hard flakes
- Details on test material:
- - Storage conditions: Room temperature protected from light.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Two and one-half to three months of age on arrival. The rabbit was approximately three months old on the day of dosing.
- Weight at study initiation: Bodyweight on the day of dosing was 2.79 kg.
- Housing: Individually housed in suspended stainless-steel cage mounted in mobile batteries. The cage measured 61 x 76 x 46 cm high and was fitted with perforated counter-sunk floor panels. A tray beneath the floor was lined with absorbent crepe paper which was changed regularly.
- Diet: ad libitum access to a commercially available standard pelleted rabbit diet.
- Water: ad libitum access to tap water supplied to each cage by an automatic piped system. The water was supplied by the East Anglian Water Company.
- Acclimation period: An acclimatisation period of at least seven days was allowed before administration of the test material. During this time the health status of the animal was monitored and a record kept. This record was consulted before the animal was allocated to study.
ENVIRONMENTAL CONDITIONS
- Temperature: Target value for temperature was 18 °C (range 15 - 23 °C)
- Humidity: Target value for humidity was 55 % R.H. (range 40 - 70 % R.H.)
- Air changes: Approximately 15 complete air changes per hour without re-circulation
- Photoperiod: 12 hours of artificial light per day
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 g of the test material - Duration of treatment / exposure:
- Single exposure
- Observation period (in vivo):
- The animal was sacrificed by intravenous injection of sodium pentobarbitone B.Vet.C immediately after the 72 hour examination.
- Number of animals or in vitro replicates:
- One acclimatised male rabbit was used on this study.
- Details on study design:
- - Both eyes of the animal were examined before administration of the test material for signs of pre-existing irritation, reaction or abnormality which would prevent it from being used on the study.
- Bodyweight was recorded for the animal on the day of receipt and at regular intervals thereafter, until the rabbit began treatment.
- The dose was instilled into the right eye by pulling the lower eyelid away from the eyeball to form a cup into which 0.1 g of the test material was dropped. The eyelid was gently held together for one second and then released. The left eye remained untreated.
- The behaviour of the rabbit was observed for several minutes immediately following instillation of the test material to allow assessment of the initial pain response
- The animal was returned to its cage and checked at least twice during the first hour after dosing and at regular intervals throughout the day to ensure no severe injury passed un-noticed. Ocular reactions to treatment were assessed one hour, 24, 48 and 72 hours after treatment.
- The untreated eye was used as a comparison with the treated eye during assessment of ocular lesions.
- The animal was checked daily to ensure the treated eye was not subject to infection or causing distress.
REMOVAL OF TEST SUBSTANCE
The test material was not removed.
SCORING SYSTEM:
Cornea
0 = No opacity
1 = Scattered or diffuse areas of opacity, (other than slight dulling of normal lustre) details of iris clearly visible
2 = Easily discernible translucent areas, details of iris slightly obscured
3 = Nacreous areas, no details of iris visible, size of pupil barely discernible
4 = Complete corneal opacity, iris not discernible
The presence or absence of ulceration or stippling of the cornea was designated by + (positive) or - (negative). Redness of the cornea such as pannus formation is described on an individual basis.
Iris
0 = Normal
1 = Markedly deepened folds, congestion, swelling, moderate circumcorneal injection (any of these or any combination of them), iris still reacting to light (sluggish reaction is positive)
2 = No reaction to light, haemorrhage, gross destruction (any or all of these)
Conjunctivae: Redness (refers to palpebral and bulbar conjunctivae)
0 = Vessels normal
1 = Some vessels definitely injected
2 = Diffuse, crimson-red, individual vessels not easily discernible
3 = Diffuse beefy-red
Chemosis (lids and/or nictitating membrane)
0 = No swelling
1 = Any swelling above normal (including nictitating membrane)
2 = Obvious swelling with partial eversion of lids
3 = Swelling with lids about half-closed
4 = Swelling with lids more than half-closed
The presence or absence of necrosis or ulceration of the conjunctiva was designated by + (positive) or - (negative).
TOOL USED TO ASSESS SCORE:
- An ophthalmoscope was used to facilitate inspection of the eyes.
- The presence of corneal lesions was confirmed by fluorescein treatment. One drop of Fluorescein Sodium B.P. (Smith and Nephew Limited) was dropped directly onto the cornea. The rabbit was allowed to blink before excess fluorescein was flushed out of the eye with physiological saline. Corneal damage was confirmed by distinctive yellow colouration of any injured areas when viewed under ultra-violet illumination.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- - Injection of the conjunctival blood vessels, a diffuse crimson-red and a beefy-red appearance to the conjunctiva, very slight and slight chemosis and slight and moderate discharge with mucus were apparent during the 72 hour observation period.
- Slight opacity covering the entire cornea was observed one hour after instillation and was accompanied by two discrete areas of severe opacity (total of approximately half of the area of the cornea) at the 24, 48 and 72 hour examinations.
- Iridial congestion was apparent at the 72 hour examination.
- Due to the severity of the reaction, the animal was humanely killed following the 72 hour examination. No further animals were committed to the study.
- Instillation of the test material caused very slight initial pain response.
Applicant's summary and conclusion
- Interpretation of results:
- other: Classified according to EU criteria as Category 1
- Conclusions:
- Under the conditions of this study the test material was considered to be 'severely irritant' with irreversible effects to the eye.
- Executive summary:
The eye irritation potential of the test material was assessed according to the standardised guidelines OECD 405 and US EPE OPP 81-4 and in compliance with GLP.
The potential of the test material to cause damage to the conjunctiva, iris or cornea was assessed in one New Zealand White rabbit subjected to a single ocular instillation of 0.1 g of the test material on Day 1. Ocular reactions were examined 1, 24, 48 and 72 hours after treatment.
Injection of the conjunctival blood vessels, conjunctival redness (diffuse and beefy-red appearance), slight chemosis and moderate discharge with mucus were apparent during the 72 hour observation period.
Slight opacity (covering the entire cornea) was observed one hour after instillation and was accompanied by two discrete areas of severe opacity (total of approximately half of the area of the cornea) at the 24, 48 and 72 hour examinations. Iridial congestion was apparent at the 72 hour examination. Due to the severity of the reaction, the animal was humanely killed following the 72 hour examination. No further animals were committed to the study.
Instillation of the test material caused very slight initial pain response.
Under the conditions of this study the test material was considered to be 'severely irritant' with irreversible effects to the eye.
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