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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: - | 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:
- From January 14, to February 12, 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study performed according to OECD test guideline No. 420 and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Version / remarks:
- 30 May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- Adopted 17 December 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- 2002
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries, Test Data for Registration of Agricultural Chemicals, Acute oral toxicity (2-1-1), 12 Nousan No 8147, Agricultural Production Bureau
- Version / remarks:
- 24 November 2000
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- UK GLP Compliance Monitoring Programme (inspected on 2018-01-16 / signed on 2018-06-05)
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- (±)-1-[(1RS,2SR,4SR)-BICYCLO[2.2.1]HEPT-2-YL]-5-HEXEN-2-ONE
- Cas Number:
- 1352216-65-9
- Molecular formula:
- C13H20O1
- IUPAC Name:
- (±)-1-[(1RS,2SR,4SR)-BICYCLO[2.2.1]HEPT-2-YL]-5-HEXEN-2-ONE
- Reference substance name:
- (±)-1-[(1RS,2RS,4SR)-BICYCLO[2.2.1]HEPT-2-YL]-5-HEXEN-2-ONE
- Cas Number:
- 1352216-63-7
- Molecular formula:
- C13H20O1
- IUPAC Name:
- (±)-1-[(1RS,2RS,4SR)-BICYCLO[2.2.1]HEPT-2-YL]-5-HEXEN-2-ONE
- Test material form:
- liquid
- Details on test material:
- Appearance: Colourless liquid
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- Storage conditions: Dry area, protected from light, in a refrigerator (temp 2-8°C), store under nitrogen in a closed container after first opening.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS (RccHanTM:WIST)
- Source: Envigo RMS (UK) Ltd
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 153-176 g
- Fasting period before study: overnight prior to and approximately four hours after dosing.
- Housing: grouped in group of one or four rats in polypropylene cages with stainless steel mesh lids and furnished with softwood based bark-free fiber bedding.
- Diet (e.g. ad libitum): Rodent 2014C Teklad Global Certified Diet ad libitum. Not contaminated.
- Water (e.g. ad libitum): Tap water ad libitum. Not contaminated.
- Acclimation period: at least 5 days before treatment.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 40-70
- Air changes (per hr): TBC
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 14 January 2019 To: 12 February 2019
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: Corn oil was used because the test item did not dissolve/suspend in distilled water.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
DOSAGE PREPARATION: The test item formulations were prepared on the day of dosing. - Doses:
- 300 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 300 mg/kg bw: 1 female
2000 mg/kg bw: 5 females - Control animals:
- no
- Details on study design:
- SIGHTING TEST
- a single animal per dose, 300 and 2000 mg/kg bw
MAIN TEST
- 5 animals per dose level (made up of one animal from the sighting test dosed at the selected dose level together with an additional 4 animals)
- Duration of observation period following administration: 14 days
- Frequency of mortality / morbidity inspection: twice daily.
- Frequency of clinical observations: at least two occasions during the first hour following dosing (ca. thirty minutes apart) and thereafter at approximately hourly intervals for the remainder of Day 1 (for at least 4 hours). On subsequent days, the animals were observed at least once in the morning and once towards the end of the experimental day. On the day the study terminated there was only one observation (morning only).
- Weighing: recorded on Days -1, 1 (prior to dosing), 8 and 15.
- Necropsy of survivors performed: yes, on Day 15 by carbon dioxide asphyxiation. All animals were subject to a macroscopic examination. - Statistics:
- None
Results and discussion
- Preliminary study:
- In the absence of mortality at a dose levels of 300 and 2000 mg/kg bw, an additional group of animals was treated at the highest dose level (i.e 2000 mg/kg bw).
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality was observed.
- Mortality:
- There were no deaths.
- Clinical signs:
- other: Clinical signs observed were red extremities and elevated gait seen in all females dosed at 2000 mg/kg in the main and sighting studies and underactivity, piloerection, hunched posture and yellow staining in the ventral surface were seen in four females d
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- None
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- Oral LD50 Females > 2000 mg kg bw.
- Executive summary:
In an acute oral toxicity study performed according to the OECD test guideline No. 420 and in compliance with GLP, groups of fasted, eight to twelve weeks of age Wistar (RccHanTM:WIST) female rats were given a single oral dose of ST 03 C 18 as a suspension in corn oil. Following a sighting test using two single animals at dose levels of 300 and 2000 mg/kg bw. As no mortality or toxicity was observed at 2000 mg/kg bw, an additional four fasted female animals were given a single oral dose of test item, at the highest dose level (i.e 2000 mg/kg bw). Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.
Oral LD50 Females > 2000 mg/kg bw
There were no deaths during the study.
Clinical signs observed were red extremities and elevated gait seen in all females dosed at 2000 mg/kg in the main and sighting studies and underactivity, piloerection, hunched posture and yellow staining in the ventral surface were seen in four females dosed at 2000 mg/kg in the main study. Also, hindlimbs splayed was observed for one female dosed at 2000 mg/kg in the sighting study and unsteady gait was observed for two females dosed at 2000 mg/kg in the main study and one female in the sighting study dosed at 2000 mg/kg. These signs were first noted approximately one hour after dosing. Recovery of animals, as judged by external appearance and behavior, was complete by Day 3. No clinical signs were seen in any animal dosed at 300 mg/kg.
All animals showed expected gains in bodyweight.
No abnormalities were noted at necropsy.
Under the test conditions, ST 03 C 18 is not classified as toxic if swallowed according to the Regulation (EC) No. 1272/2008 (CLP) but is included in Category 5 according to the Global Harmonised System (GHS), based on the clinical observations.
This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.
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.