Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 942-597-9 | CAS number: -
- 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:
- 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Guideline study performed under GLP. All relevant validity criteria were met.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- [(1R,2S)-1-methyl-2-[(2R)-5-methylhex-4-en-2-yl]cyclopropyl]methanol; [(1R,2S)-1-methyl-2-[(2S)-5-methylhex-4-en-2-yl]cyclopropyl]methanol; [(1S,2R)-1-methyl-2-[(2R)-5-methylhex-4-en-2-yl]cyclopropyl]methanol; [(1S,2R)-1-methyl-2-[(2S)-5-methylhex-4-en-2-yl]cyclopropyl]methanol
- EC Number:
- 942-597-9
- Cas Number:
- 1655500-83-6
- Molecular formula:
- C12H22O
- IUPAC Name:
- [(1R,2S)-1-methyl-2-[(2R)-5-methylhex-4-en-2-yl]cyclopropyl]methanol; [(1R,2S)-1-methyl-2-[(2S)-5-methylhex-4-en-2-yl]cyclopropyl]methanol; [(1S,2R)-1-methyl-2-[(2R)-5-methylhex-4-en-2-yl]cyclopropyl]methanol; [(1S,2R)-1-methyl-2-[(2S)-5-methylhex-4-en-2-yl]cyclopropyl]methanol
- Test material form:
- other: liquid
- Details on test material:
- Batch VE00340479
Purity 87.8% (Sum of the four isomers)
Constituent 1
- Specific details on test material used for the study:
- GR-50-1408 is the Givaudan identification code which was employed for ROSYFOLIA during the early, developmental and testing period.
The test substance was dosed undiluted as delivered by the sponsor. The test substance was kept at room temperature protected from light for a maximum of 4 hours prior to dosing. Based on the test substance data provided by the sponsor, it was considered that the test substance remained stable during this relatively short time period.
No correction was made for the purity/composition of the test substance. Adjustment was made for specific gravity of the test substance.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Species: Rat, Wistar strain, Crl:WI (outbred, SPF-Quality). Recognized by international guidelines as the recommended test system (e.g. OECD, EC).
Source: Charles River Deutschland, Sulzfeld, Germany.
Number of animals Pilot Study: 1 female. Main Study: 4 females per dose group (females were nulliparous and non-pregnant).
Age and body weight: Young adult animals (approx. 8-9 weeks old) were selected. Body weight variation did not exceed +/- 20% of the sex mean.
Identification: Earmark
Health inspection: At least prior to dosing. It is ensured that the animals were healthy and without any abnormality that might affect the study integrity
Environmental controls for the animal room were set to maintain 18 to 24°C, a relative humidity of 40 to 70%, at least 10 air changes/hour, and a 12-hour light/12-hour dark cycle. Any variations to these conditions were maintained in the raw data and had no effect on the outcome of the study.
Accommodation
Group housing of 3 animals per cage in labeled Makrolon cages (MIV type; height 18 cm.) containing sterilized sawdust as bedding material (Lignocel S 8-15, JRS - J.Rettenmaier & Söhne GmbH + CO. KG, Rosenberg, Germany) and paper as cage-enrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom). Acclimatization period was at least 5 days before start of treatment under laboratory conditions.
Free access to tap water and to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany).
Diet, water, bedding and cage enrichment evaluation for contaminants and/or nutrients was performed according to facility standard procedures. There were no findings that could interfere with the study.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- The test substance was dosed undiluted as delivered by the sponsor
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 2.265 mL/kg body weight
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Based on resuts from the Pilot Study - Doses:
- Single dose 2000 mg/kg (2.265 mL/kg) body weight.
- No. of animals per sex per dose:
- Four females were dosed at 2000 mg/kg body weight.
- Control animals:
- no
- Details on study design:
- Based on this "Pilot Study" results, the fixed dose level was selected for the main study where 4 females were dosed at 2000 mg/kg body weight via oral gavage and observed over a 14 day period. The animals were fasted prior to dosing and received food 3-4 hrs post-dosing. The animals were observed for signs or mortatlity twice daily, body weights recorded on days 1, 8 and 15. Clinical signs were observed on the day of dosing (Day1) and once daily until Day 15 and macroscopic examination performed after terminal necropsy.
- Statistics:
- None
Results and discussion
- Preliminary study:
- A "Pilot Study" was conducted in which females were orally administered the test substance at 2000 mg/kg body weight.. The test system and procedures were identical to those used during the main study. No mortality occurred. Hunched posture, piloerection and ptosis were noted on Days 1 and/or 2. Body weight gain was considered to be normal. No necropsy findings were noted. A fixed dose of 2000 mg/kg body weight was selected for the main study.
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred
- Clinical signs:
- other: Hunched posture and/or piloerection were noted for all animals between Days 1 and 7. Additionally, one animal showed flat posture, laboured respiration, lean appearance and ptosis on Days 1 and/or 2.
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Conclusions:
- The minimum oral lethal dose of Rosyfolia in rats was established to exceed 2000 mg/kg body weight. The LD50 cut-off value was considered to exceed 2000 mg/kg body weight.
- Executive summary:
An acute oral toxicity study was performed in rats in accordance with OECD 420 guideline for "Acute Oral Toxicity-Fixed Dose Procedure" and EC, No440/2008, B1: Acute oral toxicity, Fixed Dose Procedure. Initially, in a Pilot Study, Rosyfolia was administered by oral gavage to one female Wistar rat at 2000 mg/kg body weight and no mortality occurred or signs of significant toxicity were observed. In this main study, four female fasted rats were administered a single dose of the test article via gavage at a dose of 2000 mg/kg body weight and observed for 14 days. Clinical signs were confined to hunched posture and/or piloerection, noted for all animals between Days 1 and 7. Additionally, one animal showed flat posture, labored respiration, lean appearance and ptosis on Days 1 and/or 2. There were no effects on body weight gain and by the end of the observation period, no deaths occurred. No macroscopic abnormalities were recorded. In this study, the acute oral LD50for Rosyfolia was determined to be greater than 2000 mg/kg body weight.
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.