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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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 23 September to 14 October 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- 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:
- - Name of test material (as cited in study report): Javanol
- Physical state: Pale yellow viscous liquid
Test animals
- Species:
- rat
- Strain:
- other: Hanlbm: WIST (SPF) rats
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd
Wölferstrasse 4, CH-4414 Fullinsdorf / Switzerland
- Age at study initiation:
Males: 8 weeks
Females: 10 weeks
- Weight at study initiation:
Males: 201 - 211 g
Females: 174 - 187 g
- Fasting period before study: overnight prior to intubation
- Housing: Makrolon type-4 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: one week under laboratory 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
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 400
- Details on oral exposure:
- The animals received a single dose of the test article on a mg/kg body weight/day basis by oral gavage following fasting for approximately 17 hours, but with free access to water. Food was provided again approximately 3 hours after dosing.
Dose / kg body weight/day : 2000 mg
Application volume / kg body weight/day : 10ml
Rationale: Oral administration was used as this one possible route of human exposure during manufacture, handling and use of the test article. - Doses:
- 2000 mg/ kg bw/d
- 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. 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
- Mortality:
- No deaths occurred during the study.
- Clinical signs:
- other: No clinical signs of toxicity were observed during the study period.
- Gross pathology:
- No macroscopic findings were observed at the necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The median lethal dose of Javanol after single oral administration to rats of both sexes, observed over a period of 14 days is :
LD50 : greater than 2000 mg/kg - Executive summary:
The study was performed to assess the acute oral toxicity of Javanol in Wistar (SPF) rats, in accorance with the GLP principles and following OECD 401 test guidelines (adopted 1987) and Method B1 Acute Toxicity-Oral (Acute Toxic Class Method) of the EC Directive No. 92/69/EEC. In the study, a group of five male and five female HanIbm: WIST (SPF) rats was treated with Javanol at 2000 mg/kg by oral gavage. The test article was suspended in vehicle polyethylene glycol (PEG400) at a concentration of 0.2 g/ml and administered at a volume of 10 ml/kg. The animals were examined for clinical signs four times during day 1 once daily during days 2 -15. Mortality/viability were recorded together with clinical signs at the same time intervals. Body weights were recorded on day 1 prior to administration and on days 8 and 15. All animals were necropsied and examined macroscopically.
No deaths occured during the study and no clinical signs of toxicity were observed during the observation period.
The body weight of the animals was within the range of physiological variability known for rats of this strain and age and no macroscopic findings were observed at necropsy.
The LD50 for the study was greater than 2000 mg/kg bw. Therefore, it is not classified according to the Regulation (EC) No. 1272 -2008 and according to the GHS. No signal word or hazard statement is required.
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