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EC number: 458-930-1 | CAS number: -
- 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
Specific investigations: other studies
Administrative data
- Endpoint:
- specific investigations: other studies
- 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:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- in vivo
- Endpoint addressed:
- skin irritation / corrosion
Test material
- Details on test material:
- - Name of test material (as cited in study report): Ceraphyl 55
- Supplied by: International Specialty Products Inc.
- Physical state:clear liquid
- Lot/batch No.: A7281
- Storage condition of test material: room temperature
- Sample preparation: the test article was used as received and mixed with a mixture of acetone/olive oil to appropriate concentrations.
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- Balb/c
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals, Boyertown, PA
- Received on: 04/06/2004 and 04/20/2004
- Date of birth: 2-15-2004 and 2-24/2004
- Weight at study initiation: 17-23 g
- Housing: 1/cage- suspended wire cages
- Diet (e.g. ad libitum): fresh PMI Rodent Chow (Diet 5001)
- Water (e.g. ad libitum): freely available
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled
- Photoperiod (hrs dark / hrs light): 12 hr light/ 12 hr dark
Administration / exposure
- Route of administration:
- dermal
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- TEST SITE
- Area of exposure: 2 cmx2 cm
- % coverage: 100%
- Type of wrap if used: no wrap used
- Time intervals for shavings or clipplings: the area was clipped free of hair once, before the test.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): washing done with distilled water
- Time after start of exposure: 24 hr
TEST MATERIAL
- Total dose: 5000 mg/kg
- Dose used (if solution): 25 ul - Duration of treatment / exposure:
- 0-23 days (depending on the application side)
Doses / concentrations
- Remarks:
- Doses / Concentrations:
25 ul
Basis:
other: contact
- No. of animals per sex per dose:
- General test:
2 groups - 5 animal each - Control animals:
- no
Examinations
- Examinations:
- Dermal observation, using the Draize Dermal Scoring Code below, were performed at the following intervals:
Group 1:
- dilution: 100%
- animals: 1-5
- ears (day): 0-3
- trunk (day): 0-3
Dermal observation, using the Draize Dermal Scoring Code below, were performed at the following intervals:
Group 2:
- dilution: 100%
- animals: 6-10
- ears (day): 0-3
- trunk (day): 0-3
Ear measuraments: ear thickness was measured to 0.01 mm using a thickness gauge at the following intervals:
Group 1: Day 0-3
Group 2: Day 0-3
Type and Frequency of Observation
- in vivo: All animals were observed at 1, 2 and 4 hr post dose and once daily for signs of pharmacologic or toxicologic effects. Animals were examined twice daily for mortality. Body weights were recorded pre-test, weekly, at death and at termination in the survivors.
-post mortem: Animals in a critical conditions and not expected to survive untill the next observation interval, were sacrificed using CO2. At study termination all survivors were sacrificed in the same manner. All animals were examined for gross pathology including auricular lymph nodes.
Results and discussion
- Details on results:
- Group 1: erythema scores ranged from 0 to 1 on both ears and trunk. No edema was noted. Four of five animals died within 72 hr of the 5000 mg/kg application. Pre-death physical signs included lethargy, ataxia, dyspnoea, tremors, flaccid muscle tone were recorded. Necropsy revealed abnormalities of the liver, gastrointestinal tract, emaciation and wetness of anogenital area (one animal). The auricular lymph nodes appeared normal.
Group 2: erythema and edema were absent on both ears and trunk. Three of five animals were sacrificed because the critical conditions (72 hr of the 5000 mg/kg application). Pre-death physical signs included lethargy, ataxia, dyspnoea, tremors, flaccid muscle tone were recorded. Necropsy revealed abnormalities of the liver, gastrointestinal tract, emaciation and wetness of anogenital area (one animal). The auricular lymph nodes appeared normal.
Group 3: erythema and edema were absent on both ears and trunk through day 9 and 10/11, respectively. No abnormal physical signs were recorded through day 8. Two animals experienced lethargy, wetness of the anogenital area. One animal died on day 10, the second was sacrificed due to the critical conditions.
Necropsy in those two animals showed abnormalities in the gastrointestinal tract and wetness of the anogenital area. The auricular lymph nodes appear larger than normal.
Group 4: erythema and edema were absent on both ears and trunk on days 0, 1, 2, 3, 4, 14 and 15. Signed of very well defined erythema was found on days 16, 17, 18. Edema was absent to very slight on days 16, 17, and 18. The trunk area showed dermal scores on days 16, 17, 18, absent on days 23,24,25.
No abnormal physical signs were recorded through day 15. One animal experienced lethargy, wetness of the anogenital area and on day 17 was sacrificed due to the critical conditions. Necropsy of the moribund animal showed wetness of the anogenital area. The auricular lymph nodes appear larger than normal. Alopecia at the base of the ears was notices in all the survived animals
Group 5: erythema and edema were absent on both ears and trunk on days 0, 1, 2, 3, 4, 14 and 15 and 16. Dermal scores were absent on days 23, 24, 25.
No abnormal physical signs were reordered during the study and necropsy resulted normal.
Group 6: erythema and edema of both ears were absent on day 23, 24, 25. No abnormal physical signs were recorded during the study and necropsy resulted normal.
Group 7 (control): No erythema or edema was noted. No abnormal physical signs were recorded during the study and necropsy resulted normal
Applicant's summary and conclusion
- Conclusions:
- Prolonged dermal exposure of mice ears to 75% of Ceraphyl 55 caused no abnormal physical signs and necropsy resulted normal.
- Executive summary:
The study was conducted to determine the potential toxicity of Ceraphyl 55 when applied dermally to the dorsal and trunk area and the irritation potential for irritation when administered to the ear. Thirty-five female Balb/C Mice were assigned to seven groups corresponding to 6 different concentrations and the control. The results of G (Group) 1 (100%) showed erythema scores ranged from 0 to 1 on both ears and trunk. No edema was noted. However, four of five animals died within 72 hr of the 5000 mg/kg application. Pre-death physical signs included lethargy, ataxia, dyspnoea, tremors, flaccid muscle tone were recorded. Necropsy revealed abnormalities of the liver, gastrointestinal tract, emaciation and wetness of anogenital area (one animal). The auricular lymph nodes appeared normal. In G2 (100%) erythema and edema were absent on both ears and trunk. Three of five animals were sacrificed because the critical conditions (72 hr of the 5000 mg/kg application). Pre-death physical signs included lethargy, ataxia, dyspnoea, tremors, flaccid muscle tone were recorded. Necropsy revealed abnormalities of the liver, gastrointestinal tract, emaciation and wetness of anogenital area (one animal). The auricular lymph nodes appeared normal. In G3 (75%) erythema and edema were absent on both ears and trunk through day 9 and 10/11, respectively. No abnormal physical signs were recorded through day 8. Two animals experienced lethargy, wetness of the anogenital area. One animal died on day 10, the second was sacrificed due to the critical conditions. Necropsy in those two animals showed abnormalities in the gastrointestinal tract and wetness of the anogenital area. The auricular lymph nodes appear larger than normal. Regarding G4 (75%), erythema and edema were absent on both ears and trunk on days 0, 1, 2, 3, 4, 14 and 15. Signed of very well defined erythema was found on days 16, 17, 18. Edema was absent to very slight on days 16, 17, and 18. The trunk area showed dermal scores on days 16, 17, 18, absent on days 23, 24, 25. No abnormal physical signs were recorded through day 15. One animal experienced lethargy, wetness of the anogenital area and on day 17 was sacrificed due to the critical conditions. Necropsy of the moribund animal showed wetness of the anogenital area. The auricular lymph nodes appear larger than normal. Alopecia at the base of the ears was notices in all the survived animals. In G5 (50%) erythema and edema were absent on both ears and trunk on days 0, 1, 2, 3, 4, 14 and 15 and 16. Dermal scores were absent on days 23, 24, 25. No abnormal physical signs were recorded during the study and necropsy resulted normal. In G6 (50%) erythema and edema of both ears were absent on day 23, 24, 25. No abnormal physical signs were recorded during the study and necropsy resulted normal. Finally, the G7 (control) showed no erythema or edema. No abnormal physical signs were recorded during the study and necropsy resulted normal.
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