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EC number: 443-870-0 | CAS number: 163520-33-0
- 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
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 May - 25 Jun 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)
- Version / remarks:
- Adopted in 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.9 (Repeated Dose (28 Days) Toxicity (Dermal))
- Version / remarks:
- Adopted in 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 82-2 (Repeated Dose Dermal Toxicity -21/28 Days)
- Version / remarks:
- Adopted in 1984
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 443-870-0
- EC Name:
- -
- Cas Number:
- 163520-33-0
- Molecular formula:
- C18H17NO3
- IUPAC Name:
- ethyl 5,5-diphenyl-4,5-dihydro-1,2-oxazole-3-carboxylate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- CRL:CD (SD) BR
- Details on species / strain selection:
- The rat was chosen as the test system according to regulatory guidelines.
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Ltd., Margate, UK
- Age at receipt: approximately 42 days
- Body weight at receipt: males: 180 - 196 g, females: 188 - 207 g
- Housing: individually, in polycarbonate cages with mesh bases suspended over waste trays. The waste tray of each cage was lined with absorbent paper
- Diet: ground laboratory rodent diet, Modified SQC Expanded Rat and Mouse Maintenance Diet No. 1 (Special Diet Services Ltd., Witham, UK), ad libitum
- Water: tap water in drinking water quality, ad libitum
- Acclimation period: 6 days
DETAILS OF FOOD AND WATER QUALITY: At their respective levels in the diet and water, none of the contaminants known or expected to be present was considered likely to influence the outcome of the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 27 May 1997 To: 25 Jun 1997
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: 1% (w/v) methyl cellulose in water
- Details on exposure:
- TEST SITE
- Area of exposure:dorsal area of the trunk
- % coverage: 10%
- Type of wrap if used: the test substance was held in contact with the skin on a 2 x 2 cm pad of porous gauze pad backed by aluminium foil which was held in place over the treatment site by elastic bandage
- Time intervals for shavings or clippings: clipping was repeated as necessary during the study
REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test material was rinsed of with soap and water
- Time after start of exposure: 6 h
TEST MATERIAL
- Amount applied: 5 mL/kg bw, daily preparation of test suspension
- Concentration: 2, 20 and 200 mg/mL
- Constant concentration used: yes
VEHICLE
- Amount(s) applied (volume or weight with unit): 5 mL/kg bw
USE OF RESTRAINERS FOR PREVENTING INGESTION: no - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The samples were analysed by extraction of AE F122006 from the suspensions by shaking with acetonitrile + methanol (90 + 10, v/v). The concentration of the test substance in the extract was measured by HPLC using UV detection.The mean results for the test suspension samples analysed and prepared for dosing were within the range 89.5 to 122.3% of nominal at the time of preparation (specified range +20% to -20% of nominal).
- Duration of treatment / exposure:
- 28 days (males)
29 days (females) - Frequency of treatment:
- 5 days/week, excluding weekends
Doses / concentrationsopen allclose all
- Dose / conc.:
- 10 mg/kg bw/day
- Dose / conc.:
- 100 mg/kg bw/day
- Dose / conc.:
- 1 000 mg/kg bw/day
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Dose levels were selected on the basis of findings in an earlier dose ranging study conducted immediately prior to this study with 4 groups of 3 males dosed at 0, 250, 500 and 1000 mg test substance kg bw/day for 7 days, excluding the weekend. There were no treatment-related effects at 1000 mg/kg bw/day, equivalent to the accepted international regulatory limit dose, in this range-finding study.
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Animals were observed each morning for abnormal behaviour, including neuro-muscular coordination and physical appearance. Animals were also observed in the afternoon on Mondays to Fridays except on public and Company holidays.
DETAILED CLINICAL OBSERVATIONS: No
DERMAL IRRITATION (if dermal study): Yes
- Time schedule for examinations: daily
BODY WEIGHT: Yes
- Time schedule for examinations: Each animal was weighed at randomisation, at the start of treatment, weekly thereafter and at
necropsy.
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
FOOD EFFICIENCY: No
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: Day 29
- Anaesthetic used for blood collection: Yes (ether)
- Animals fasted: No
- How many animals: 5 per sex and dose
- Parameters examined: Haematocrit (HCT), White blood cells (WBC), Haemoglobin (HB), Neutrophils (NEUT), Red blood cells (RBC), Lymphocytes (LYMP), Mean corpuscular volume (MCV), Monocytes (MONO), Mean corpuscular haemoglobin (MCH), Mean corpuscular haemoglobin concentration (MCHC), Eosinophils (EOS), Basophils (BASO), Large unstained cells (LUC), Platelets (PLT), Reticulocyte count (RET), Prothrombin time (PT), and Activated partial thromboplastin time (APTT).
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: Day 29
- Animals fasted: No
- How many animals: 5 per sex and dose
- Parameters examined: Total protein (PROT), Albumin (ALB), Total globulin (GLOB), A/G ratio (A/G), Calcium (CA), Phosphate (PO4), Sodium (Na), Potassium (K), Urea (UREA), Creatinine (CREAT), Glucose (GLUC), Total cholesterol (CHOL), Total bilirubin (TBIL), Chloride (Cl), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (AP), G-glutamyl transpeptidase (GGT), and Creatine kinase (CPK).
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, organ weights of kidneys, adrenals, liver and testes were recorded. Following tissues were fixed in 10% neutral buffered formalin: kidneys, liver, ovaries, pinnae, skin (treated and untreated), testes, adrenals, and any other tissue showing macroscopic abnormalities.
HISTOPATHOLOGY: Yes, of kidney and liver sections and treated and untreated skin. - Statistics:
- The significance of differences between control and treated groups was analysed by either parametric or non-parametric statistical tests as appropriate. A maximum 2-tailed probability value of 5% (p <0.05) was considered statistically significant.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- Test substance related clinical signs other than local dermal irritation were not evident.
- Dermal irritation:
- effects observed, treatment-related
- Description (incidence and severity):
- At 1000 mg/kg bw/day, slight dermal irritation, as indicated by skin reddening at the application site, was seen in all animals from Week 2 till study termination. Slight sloughing, defined as shedding of the superficial layer of skin at the application site, was seen in 3/5 males and 3/5
females from Week 2 until Week 3 and 4, respectively.
At 100 mg/kg bw/day, slight dermal irritation was seen in 2/5 females from Day 4 and 11 to Day 6 and 19, respectively. - Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- No treatment-related effects were observed. At the 1000 mg/kg bw/day dose level a mild decrease in cholesterol levels was observed in female animals compared with concurrent control, but this decrease was within the normal physiological range of control data.
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- 100 mg/kg bw/day: scabs at the application site in 2/5 female rats
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- At 1000 mg/kg bw/day, 3/5 males and 5/5 females had mononuclear cell infiltration of the dermis to a moderate degree.
At 100 mg/kg bw/day, 2/5 males and 3/5 females had moderate cell infiltration.
At 10 mg/kg bw/day, 1/5 males had a mild infiltration. Because a similar lesion was observed in a control female this is considered not to be induced by application of the test compound. - Histopathological findings: neoplastic:
- not examined
Effect levels
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- systemic
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no effects observed
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- local
- Effect level:
- 10 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no cell infiltration observed at doses <100 mg/kg bw/day
- Remarks on result:
- other: 0.5 mg/cm²/day, calculated based on a body weight of 200 g and a patch area of 4 cm²
- Key result
- Dose descriptor:
- LOAEL
- Remarks:
- local
- Effect level:
- 100 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- gross pathology
- histopathology: non-neoplastic
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Applicant's summary and conclusion
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.