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EC number: 433-930-4 | CAS number: 247089-62-9
- 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
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
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
Test material
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK, Margate, Kent, England.
- Age and weight at study initiation: Animals used within the study were at least 6 weeks old and body weights were less than 3.5 kg.
- Accomodation: Individually housed in labelled cages with perforated floors (Scanbur, Denmark) and equipped with an automatic drinking system (ITL, Bergen, The Netherlands).
- Diet (e.g. ad libitum): Standard laboratory rabbit diet (Charies River Breeding and Maintenance Diet for Rabbits, Altromin, Germany) approx. 100 g. per day. Certificates of analysis were examined and retained in the NOTOX archives. In addition, hay (BMI, Helmond, the Netheriands) was provided once a week.
- Water (e.g. ad libitum): Free access to tap-water. Certificates of quarteriy analysis were examined and retained in the NOTOX archives.
- Acclimation period: Acclimatisation period was at least 5 days before start of treatment under laboratory conditions.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 27.6 ± 1.0 mg of the test substance (a volume of approximately 0.1 ml) in the conjunctival sac of one of the eyes
- Duration of treatment / exposure:
- 24h
- Observation period (in vivo):
- The eyes of each animal were examined approximately 1, 24, 48 and 72 hours after instillation of the test substance.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- After administration, the lids were then gently held together for about one second to prevent loss of the test substance. The other eye remained untreated and served as the reference control.
Immediately after the 24 hour observation, a solution of 2% fluorescein in water (adjusted to pH 7.0) was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage. Any bright green stained area, indicating epithelial damage, was estimated as a percentage of the total corneal area.
SCORING SYSTEM:
CORNEAL IRRITATION
Opacity: degree of density (area most dense taken for reading)
No ulceration or opacity (may include slight dulling of normal lustre) 0
Scattered or diffuse areas of opacity, details of iris clearly visible 1
Easily discemible translucent area, details of iris slightly obscured 2
Nacreous area, no details of iris visible, size of pupil barely discemible 3
Opaque cornea, iris not discemible through the opacity 4
Area of comea involved:
No ulceration or opacity 0
One quarter or less but not zero 1
Greater than one quarter, but less than half 2
Greater than half, but less than three quarters 3
Greater than three quarters, up to whole area 4
IRIS
Normal 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia,
or injection, any of these or combination thereof, iris still reacting to light
(sluggish reaction is positive) 1
No reaction to light, hemorrtiage, gross destruction (any or all of these) 2
CONJUNCTIVAL IRRITATION
Redness (refers to palpebrae and sclera, excluding comea and iris):
Blood vessels normal 0
Some blood vessels definitely hyperaemic (injected) 1
Diffuse, crimson color, individual vessels not easily discemible 2
Diffuse beefy red 3
Chemosis (refers to lids and/or nictitating membranes):
No swelling 0
Any swelling above normal (Includes nictitating membranes) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half closed 3
Swelling with lids more than half closed 4
Discharge:
No discharge (may include small amounts observed in inner canthus of normal animals) 0
Any amount different from normal and/or lacrimation 1
Discharge with moistening of the lids and hairs just adjacent to lids 2
Discharge with moistening of the lids and hairs (considerable area around the eye) 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: all time points
- Score:
- 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: all time points
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: all time points
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: all time points
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Instillation of approximately 28 mg of the test substance (a volume of approximately 0.1 ml) into one eye of each of three rabbits resulted in irritation of the conjunctivae, which was seen as redness and discharge. The irritation had completely resolved within 24 hours in two animals and within 48 hours in the other animal. No iridial irritation or corneal opacity were observed, and treatment of the eyes with 2% fluorescein, 24 hours after test substance instillation revealed no corneal epithelial damage in any of the animals. There was no evidence of ocular corrosion.
- Other effects:
- Red staining of the fur on the head and paws, caused by the test substance, was noted throughout the observation period. Remnants of the test substance were present in the eyes of all animals on day 1 and on the outside of the eyelids of all animals on day 2. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information
- Conclusions:
- Based on these results TKP 50048 induces minor eye irritation.
- Executive summary:
Single samples of approximately 28 mg of TKP 50048 (a volume of approximately 0.1 ml) were instilled into one eye of each of three rabbits. Observations were made 1, 24, 48 and 72 hours after instillation.
Instillation of the test substance resulted in irritation of the conjunctivae, which was seen as redness and discharge. The irritation had completely resolved within 24 hours in two animals and within 48 hours in the other animal. Red staining of the fur on the head and paws, caused by the test substance, was noted throughout the observation period. Remnants of the test substance were present in the eyes of all animals on day 1 and on the outside of the eyelids of all animals on day 2.
Based on these results TKP 50048 induces minor eye irritation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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