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EC number: 427-900-1 | CAS number: 198404-98-7
- 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:
- From 5 october 1999 to 26 october 1999
- 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 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Cyclopropanemethanol, 1-methyl-2-[[(1S,3R,5R)- 1,2,2-trimethylbicyclo[3.1.0]hex-3-yl]methyl]-, (1S,2S)-, rel-
- Molecular formula:
- C15H26O
- IUPAC Name:
- Cyclopropanemethanol, 1-methyl-2-[[(1S,3R,5R)- 1,2,2-trimethylbicyclo[3.1.0]hex-3-yl]methyl]-, (1S,2S)-, rel-
- Reference substance name:
- Cyclopropanemethanol, 1-methyl-2-[[(1S,3R,5R)- 1,2,2-trimethylbicyclo[3.1.0]hex-3-yl]methyl]-, (1R,2R)-, rel-
- Molecular formula:
- C15H26O
- IUPAC Name:
- Cyclopropanemethanol, 1-methyl-2-[[(1S,3R,5R)- 1,2,2-trimethylbicyclo[3.1.0]hex-3-yl]methyl]-, (1R,2R)-, rel-
- Test material form:
- liquid
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- Substance identity: Javanol
Appereance: Liquid
Test animals
- Species:
- rat
- Strain:
- other: HanBrl: WIST (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd - Biotechnology & Animal Breeding Division CH-4414 Füllinsdorf / Switzerand
- Age at study initiation:
Males: 9 weeks
Females: 12 weeks
- Weight at study initiation:
Males: 235.2 to 242.5 g
Females: 201.3 to 221.4 g
- Fasting period before study: NA
- Housing: individually in Makrolon type-3 cages
- Diet (e.g. ad libitum): Pelleted standard Kliba 3433, ad libitum
- Water (e.g. ad libitum):Community tap water from Itingen, ad libitum
- Acclimation period: 7 days under laboratories conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 40-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 24 hours before treatment the backs of the animals were clipped with an eletric clipper
- % coverage: 10% of total body surface
- Type of wrap if used: semi-occlusive dressing and fixed with an elastic adhesive bandage.
REMOVAL OF TEST SUBSTANCE
- Twenty-four hours after the application, the dressing was removed and the skin was flushed with lukewarm tap water and dried with disposable paper towels and the reaction sites were assessed.
TEST MATERIAL
- Amount applied (volume or weight with unit): 2000 mg/kg body weight - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- Mortality/Viability:four times during test day 1 and once daily for surviving animals during days 2-15.
Body weights: on test day 1 (pre-administration), 8 and 15 for surviving animals.
Clinical signs: each animal was examined for changes in appearance and behaviour four times during day 1, and once daily for surviving animals during days 2-15.
Necropsy: Necropsies were performed by experienced prosectors. At the end of observation period all animals were sacrificed by intraperitoneal injection of Narcoren at a dose of at least 2.0 ml/kg body weight. The animals were examined macroscopically and all abnormalities recorded. Thereafter, they were discarded. - Statistics:
- No statistical analysis was used as no deaths occured.
Results and discussion
Effect levels
- Key result
- 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.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The median lethal dose of Javanol after a single dermal administration to rats of both sexes, observed over a period of 14 days is:
LD50 rat : greater than 2000 mg/kg body weight - Executive summary:
The acute dermal toxicity of the test material was assessed in five male and five female HanIbm: WIST (SPF) rats. The animals were dermally treated with undiluted Javanol at 2000 mg/kg bw. The test material was applied to the clipped skin (backs) of the rats and covered with semi-occlusive dressing for 24 hours. After the 24hr exposure period, the skin was flused with water and the site assessed for reactions and the animals were observed over a 14 -day period. The animals examined for clinical signs four times during day 1 and once daily during days 2 -15, along with mortality/viability
Body weights were recorded on day 1 prior to administration and on days 8 and 15. At termination, all animals were necropsied and examined macroscopically. No deaths occured during the study and no systemic or local signs of toxicity observed during the observation period. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy. The LD50 for this study was greater than 2000 mg/kg body weight.
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