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EC number: 444-860-9 | CAS number: 474510-57-1
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002-09-19 to 2002-10-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- adopted 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- adopted 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 444-860-9
- EC Name:
- -
- Cas Number:
- 474510-57-1
- Molecular formula:
- C21 H24 O4
- IUPAC Name:
- 2-hydroxy-1-(4-{[4-(2-hydroxy-2-methylpropanoyl)phenyl]methyl}phenyl)-2-methylpropan-1-one
- Details on test material:
- - Description: slightly yellow solid
- Purity: Unknown; excluded from the statement of compliance.
- Stability of test item dilution: Stable in PEG 300 at least 1 hour.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd, Biotechnology and Animal Breeding Division; CH-4414 Füllinsdorf / Switzerland
- Age at study initiation: Males: 9 weeks; Females: 10 weeks
- Weight at study initiation (mean): Males: 257.9 g; Females: 202.18 g
- Fasting period before study: no
- Housing: In groups of 5 rats/sex in Makrolon type 4 cage.
- Diet: Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 34/02
- Water: Community tap water from Füllinsdorf ad libitum.
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 30-70 %
- Air changes: 10-15 air changes per hour
- Photoperiod: 12 hours fluorescent light/ 12 hours dark, music during the light period
IN-LIFE DATES: From: 19-Sept-2002 To: 10-Oct-2002
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- polyethylene glycol
- Remarks:
- (PEG 300)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: approximately 10 % of the total body surface
- % coverage: no data
- Type of wrap if used: The dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the skin was flushed with lukewarm tap water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): no data
- Concentration (if solution): 500 mg/mL per kg bw, based on dose volume
- Constant volume or concentration used: yes
- For solids, paste formed: no
VEHICLE
- Amount(s) applied (volume or weight with unit): 4 mL/kg bw
- Concentration (if solution): no data
- Lot/batch no. (if required): 4333371/1 20602
- Purity: no data - Duration of exposure:
- single dose
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 rats
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Mortality / Viability: daily during acclimatization and twice daily during days 1 -15; body weights:on test days 1 (prior to administration), 8 and 15; clinical signs: daily during acclimatization and at approximately 1, 2, 3 and 5 hours after administration on test day 1. Once daily during days 2-15. All abnormalities were recorded.
- Necropsy of survivors performed: yes - Statistics:
- No statistical analysis was used.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred during the study.
- Clinical signs:
- other: No systemic or local signs of toxicity were observed during the study period.
- Gross pathology:
- No macroscopic findings were observed at necropsy.
Any other information on results incl. tables
The median lethal dose of the test item after single dermal administration to rats of both sexes, observed over a period of 15 days is: LD50 (rat): greater than 2000 mg/kg bw.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Conclusions:
- The dermal acute LD50 of the test material is >2000 mg/kg bw in Rats (both sexes).
- Executive summary:
In this guideline (OECD 402) study conducted with GLP certification, the acute dermal LD50 of the test material (EC 444-860-9) to the rat was determined to be >2000 mg/kg bw (both sexes). The test material was administered under occlusive conditions as a limit test (2000 mg/kg bw) to male and female for 24 hours, with a post application observation period of 15 days. The result of the test does not trigger classification of the test material as acutely toxic according to the EU Classification, Labelling, and Packaging (CLP) regulation (1272/2008).
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