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EC number: 478-920-0 | CAS number: 457632-32-5
- 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
Endpoint summary
Administrative data
Description of key information
One Guideline study on skin irritation, in vivo
One Guideline study on eye irritation, in vivo
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10. December 2007 - 18. January 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 5-4-A
- Expiration date of the lot/batch: October 2008
- Purity test date: not stated
RADIOLABELLING INFORMATION (if applicable)
not applicable
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperater, light protected
- Stability under test conditions: stable under storage conditions
- Solubility and stability of the test substance in the solvent/vehicle: not applicable
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
none - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Netherlands BV
- Age at study initiation: 12 weeks (male) 11-12 weeks (female)
- Weight at study initiation: 2052 - 2147 g
- Housing: individually
- Diet (e.g. ad libitum): ad libitim
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 14 or 16 pellets of Nomcort HKP, placed on surgical gauze patch to cover an area of approx. 6 cm2
- Duration of treatment / exposure:
- 4
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2
- % coverage: not stated
- Type of wrap if used: semi-occlusive dressing, fixed with tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lukewarm water
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
1, 24, 48 and 72 hours
(indicate if minutes, hours or days)
SCORING SYSTEM:
- Method of calculation: according to Guideline - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Other effects:
- no other effects reported
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, Nomcort HK-P is not a skin irritant.
- Executive summary:
The primary skin irritation potential of Nomcort HK-P was investigated according to OECD test guideline no. 404. The test item was applied by topical semi-occlusive application on an area of approximately 6 cm2 to the intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. the scoring of skin reaction was performed 1, 24, 48 and 72 hours after removal of the dressing.
The mean score was calculated across 3 scoring times (24, 48 and 72 hours afterpatch removal) for each animal for erythema/eschar grades and for oedema grades, separately.
The test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The individual mean score for erythema/eschar and oedema for each of the three animals was therefore 0.
The test item caused no staining of the treated skin. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed.
Thus, the test item did not induce significant or irreversible damage to the skin.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19. June - 23 June 2000 (experimental interval)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- This test was designed to detennine the ocular irritation potential of substances in the non-rinsed
eyes of three (3) rabbits. The procedure is a modification of that desciibed by J.H. Draize (J.H. Draize, "Deimal Toxicity", Appraisal of the Safety of Chemicals in Foods, Drugs and
Cosmetics, (The Association of Food and Drug Officials of the United States, 1959), pp. 49 - 51.). This protocol was designed to satisfy the requirements of the Japanese Ministry of Health and
Welfare. - GLP compliance:
- no
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 0-3-A
- Expiration date of the lot/batch: not stated
- Purity test date: not stated
RADIOLABELLING INFORMATION (if applicable)
not applicabble
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: not stated
- Stability under test conditions: not stated
- Solubility and stability of the test substance in the solvent/vehicle: not applicable
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
not stated
Test Article is described as liquid - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Three (3), female, New Zealand white rabbits weighing approximately two (2) kilograms and
about three (3) months of age, were used for each test atiicle. The animals were obtained
through a suitably licensed dealer. The animals were checked carefully upon receipt for ocular
defects, diarrhea and dehydration, respiratory difficulties, postural deficiencies, and general
condition. Any animal exhibiting visible ocular defects or irritation, or poor condition, was
rejected.
The animals were acclimated for five (5) days prior to test initiation. They were individually
housed in stainless steel cages, in a temperature controlled room, with a 12 hour light/dark cycle
and identified through individual markings on the outer ear of each animal, as well as a cage
label. The room temperature was controlled to comply with Animal Welfare Regulations with an
approximate range of 65° to 15° F. The humidlity was also monitored. Diet consisted of Lab
Diet Certified Rabbit Diet #5322, at 100 grams per day per animal. Water was provided ad
libitum. - Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- 0.1 ml of 20 % solution.
- Duration of treatment / exposure:
- 24 hour before washing
- Observation period (in vivo):
- at 1, 24, 48 and 72 hours
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): if necessary, washing is done after 24 hours
- Time after start of exposure: 24 hours
SCORING SYSTEM:
comparable to Guideline:
A Opacity (0-4)
B Area of Cornea involved (0-4)
C Iris (0-2)
D Conjunctivae Redness (0-3)
E Conjunctivae Chemosis (0-4)
F Conjunctivae Discharge (0-3)
Total score = (A*B*5)+(C*5)+((A+B+C)*2) = 110
TOOL USED TO ASSESS SCORE: not stated - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- two animals showed in the course of the study mild redness of the conjunctivae (score 1). No other signs of irritation were noted.
- Other effects:
- no other effects noted
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this test, Nomcort HK-P elicited mild, reversible, conjunctival initation to the eyes of rabbits. However the effects are not sufficient for meeting the classification criteria.
- Executive summary:
Three (3) New Zealand white rabbits, free from visible ocular defects, each
received a single intraocular application of one-tenth of one milliliter (0.1 ml) of
the test article in one (1) eye. The contralateral eye, remaining untreated, served as
a control. The eyes of all animals remained unwashed for 24 hours. Observations
of corneal opacity, iritis, and conjunctivitis were recorded one (1), 24, 48, and 72
hours after treatment, and at four (4) and seven (7) days, if initation persisted. The
test article was uJed as a 20% suspension in distilled water, that had been heated at
approximately 70° C for 30 minutes. The mixture was allowed to cool prior to
dosing.
--------Average Draize Scores--------
Hours Days
1 24 48 72 4 7
Unwashed 2.0 0.7 0.7 0.7 0.0 -
Conclusion: Under the conditions of this test, this test article elicited mild, reversible,
conjunctival initation to the eyes of rabbits.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
The presented information is conclusive but not sufficient for classification.
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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