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EC number: 405-040-6 | CAS number: 63500-71-0 CIS/TRANS-TIMO; FLOROL; FLOROSA
- 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:
- sub-chronic toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 411 (Subchronic Dermal Toxicity: 90-Day Study)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.28 (Sub-Chronic Dermal Toxicity Test: 90-Day Repeated Dermal Dose Study Using Rodent Species)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- BASF SE
- Limit test:
- no
Test material
- Reference substance name:
- A mixture of: cis-tetrahydro-2-isobutyl-4-methylpyran-4-ol; trans-tetrahydro-2-isobutyl-4-methylpyran-4-ol
- EC Number:
- 405-040-6
- EC Name:
- A mixture of: cis-tetrahydro-2-isobutyl-4-methylpyran-4-ol; trans-tetrahydro-2-isobutyl-4-methylpyran-4-ol
- Cas Number:
- 63500-71-0
- Molecular formula:
- C10 H20 O2
- IUPAC Name:
- 4-methyl-2-(2-methylpropyl)oxan-4-ol
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Pyranol
- Physical state: liquid / colorless, clear
- Analytical purity: 99.6 corr. area %
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Isomers composition: mixture of two diasteromers
- Homogenicity: given (visually)
- Test substance No.: 09/0639-4
- Lot/batch No.: 00027577L0
- Date of production: 29 Oct 2013
- Expiration date of the lot/batch:
- Stability under test conditions: 29 Oct 2015, stability under storage conditions over the test periond was guaranteed by the sponsor
- Storage condition of test material: ambient (room temperature)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:WI(HAN)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services GmbH, Sulzfeld, Germany
- Age at study initiation: 63 ± 1 days
- Weight at study initiation:
- Fasting period before study:
- Housing: animals were housed individually in makrolon cages, type M III with dust-free wooden bedding
- Diet: ground Kliba mouse/rat maintenance diat “GLP”, meal ad libitum
- Water: ad libitum
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- corn oil
- Details on exposure:
- TEST SITE
- Area of exposure: intact clipped skin of the back (dorsal and dorsolateral areas of the trunk)
- % coverage: not less than 10% of the body surface
- Type of wrap if used: semiocclusive dessing (4 layers of absorbent gauze and strech bandage)
- Time intervals for shavings or clipplings: at least once a week (depending on hair growth)
REMOVAL OF TEST SUBSTANCE
- Washing: with lukewarm water
- Time after start of exposure: after removal of the dressing (at least 6 hours)
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 ml/kg bw in corn oil - Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- at least 6 hours daily
- Frequency of treatment:
- 5 days per week (once daily)
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100, 300 and 1000 mg/kg bw/d
Basis:
nominal per unit body weight
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice on workdays, daily on weekends/public holidays
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: once before beginning of the applicationperiod (day 0) and subsequently once a week
DERMAL IRRITATION: Yes
- Time schedule for examinations: once each workday (immediately before application)
BODY WEIGHT: Yes
- Time schedule for examinations: before the start of application peroid, on day 0 and thereafter at weekly intervals
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
WATER CONSUMPTION: Yes
- Time schedule for examinations: daily by visual inspection
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: before administration and toward the end of the application peroid
- Dose groups that were examined: control and high dose (other dose groups will be examined only if there is a striking discrepancy between the highest dose group and the control group)
HAEMATOLOGY: Yes
- Time schedule for collection of blood: day 92 (males) and day 93 (females)
- Anaesthetic used for blood collection: Yes (isoflurane)
- Animals fasted: Yes (fasting peroid of about 16 to 20 hours)
- Blood was taken from the retro-bulbar venous plexus.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: day 92 (males) and day 93 (females)
- Anaesthetic used for blood collection: Yes (isoflurane)
- Animals fasted: Yes (fasting peroid of about 16 to 20 hours)
- Blood was taken from the retro-bulbar venous plexus.
URINALYSIS: Yes
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: once towards the end of treatment
- Dose groups that were examined: all animals
- Battery of functions tested: Home cage observation, open field observation, Sensory motor tests/ reflexes, Motor activity - Sacrifice and pathology:
- All animals were sacrified by decapitation under isoflurane anesthesia.
GROSS PATHOLOGY: Yes
Anesthetized animals, adrenal glands, kidneys, liver, tested and thyroid glands were weighed.
HISTOPATHOLOGY: Yes
The following organs or tissues will be fixed in 4% formaldehyde solution or in modified Davidson's solution:
All gross lesions, Adrenal glands, Aorta, Bane marrow (femur), Brain, Cecum, Cervix, Coagulating gland, Colon, Duodenum, Epididymides, Esophagus, Extraorbital lacrimal glands, Eyes with optic nerve (modified Davidson's solution), Femur with knee joint, Harderian gland, Heart, Ileum, Jejunum (with Peyer's patches), Kidneys, Larynx, Liver, Lung, Lymph nodes (mesenteric and axillary lymph nodes), Mammary gland (male+female), Nose (nasal cavity), Ovaries, Oviducts, Pancreas, Parathyroid glands, Pharynx, Pituitary gland, Prostate, Rectum, Salivary glands (mandibular and sublingual glands), Seminal vesicles, Sciatic nerve, Skeletal muscle, Skin treated, Skin untreated, Spinal cord (cervical, thoracic and lumbar cord), Spleen, Sternum with marrow, Stomach (forestomach and glandular stomach), Testes, Thymus, Thyroid glands, Trachea, Urinary bladder, Uterus, Vagina - Statistics:
- food consumption, body weight, body weight change: DUNNETT's test
Feces, rearing, grip strength forelimbs, grip strength hindlimbs, foot-splay test, motor activity: KRUSKAL-WALLIS test and WILCOXON-test
Results and discussion
Results of examinations
- Details on results:
- CLINICAL SIGNS AND MORTALITY
No animal died during the administration period.
Some male and female animals showed slight erythema, erosion and scales. These finding are attributed to the irritating properties of the test substance. No other abnormal clinical signs were observed.
BODY WEIGHT AND WEIGHT GAIN
Mean body weight change in females of test group 3 (1000 mg/kg bw/d) was significant higher on study day 0-14.
FOOD CONSUMPTION
No test substance-related observations were noted.
WATER CONSUMPTION
No test substance-related observations were noted.
OPHTHALMOSCOPIC EXAMINATION
No test substance-related observations were noted. All findings were assessed as being incidental in nature since they occurred in individual animals only and did not show a dose-response relationship.
HAEMATOLOGY
No treatment-related changes among haematological parameters were observed.
In males of test group 2 (300 mg/kg bw/d) staticical significant decreases in the total values of white blood cells, neutrophiles, lymphocytes and monocytes were observed. These alterations were not dose-dependent and therefore they were regarded as incidental and not treatment-related.
CLINICAL CHEMISTRY
No treatment-related changes among clinical chemistry parameters were observed.
In females of test group 2 (300 mg/kg bw/d) and 3 (1000 mg/kg bw/d) glucose values were silghtly but statistically significant increased (4.99 and 4.72 mmol/l) compared to controls (5.36 mmol/l). Although the increases in glucose were statistically significantly different to the control value and showed a dose-response relationship, these isolated findings were assessed as being fortuitous since similar increases were not observed in the males.
URINALYSIS
No treatment-related, adverse changes among urinalysis parameters were observed.
NEUROBEHAVIOUR
Deviations from "zero values" were obtained in several animals. However, as most findings were equally distributed between test-substance treated groups and controls, were without a dose-response relationship or occurred in single animals only, these observations were considered to have been incidental.
ORGAN WEIGHTS
No effects on mean absolute and relative organ weights were observed.
GROSS PATHOLOGY
All findings occurred individually. They were considered to be incidental or spontaneous in origin and without any relation to treatment.
HISTOPATHOLOGY
All findings occurred individually. They were considered to be incidental or spontaneous in origin and without any relation to treatment.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no treatment-related, adverse effects were observed
Target system / organ toxicity
- Critical effects observed:
- not specified
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.
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