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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 944-011-7 | 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:
- 1979-04-02 to 1979-04-20
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP study conducted similarly to OECD Guideline 401 with deviations: no data about purity and no certificate of analysis of the test substance; no. of animals at two dose levels < 5; no details on environmental conditions; observation period: 7 days
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- non-GLP study; no data about purity and no certificate of analysis of the test substance; no. of animals at two dose levels < 5; no details on environmental conditions; observation period: 7 days
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-6-yl pivalate
- EC Number:
- 268-259-4
- EC Name:
- 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-6-yl pivalate
- Cas Number:
- 68039-44-1
- Molecular formula:
- C15H22O2
- IUPAC Name:
- 3a,4,5,6,7,7a-hexahydro-1H-4,7-methanoinden-6-yl pivalate
- Reference substance name:
- 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-5-yl pivalate
- EC Number:
- 268-261-5
- EC Name:
- 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-5-yl pivalate
- Cas Number:
- 68039-45-2
- Molecular formula:
- C15H22O2
- IUPAC Name:
- 3a,4,5,6,7,7a-hexahydro-1H-4,7-methanoinden-5-yl pivalate
- Reference substance name:
- rel-(1R,2S,3aR,4S,5R,6aS,7R)-octahydro-1,5:2,4-dimethanopentalen-7-yl pivalate
- Molecular formula:
- C15H22)2
- IUPAC Name:
- rel-(1R,2S,3aR,4S,5R,6aS,7R)-octahydro-1,5:2,4-dimethanopentalen-7-yl pivalate
- Test material form:
- other: liquid, may crystalize to white solid
Constituent 1
Constituent 2
impurity 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): PM 343 Pivaloxycyclene
- Source: Proprietary Perfumes Ltd., UK
- Date received: 29 March 1979
- Physical state: Very pale yellow oily liquid
- Specific gravity: 1.01
- pH: 6.0
Test animals
- Species:
- mouse
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 4-5 weeks
- Housing: Animals were housed in individual cages.
- Fasting period before study: 4 h
- Diet: Commercial pelleted diet, ad libitum
- Water: Ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME ADMINISTERED: 10 mL/kg bw
- Doses:
- 2, 5 and 10 mL/kg bw
- No. of animals per sex per dose:
- 5 mL/kg bw: 3/sex/dose
2 and 10 mL/kg bw: 1/sex/dose - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days
- Survivors were weighed before killing for post-mortem examination at the end of the one week observation period.
- Necropsy of survivors or dead animals performed: Yes - Statistics:
- None
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 5 mL/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: equivalent to 5330 mg/kg bw; calculated using the density of 1.066 g/L (literature)
- Mortality:
- - Both mice (2/2) dosed at 10.0 mL/kg bw and 4/6 mice dosed at 5.0 mL/kg bw died within 24-48 h after treatment.
- Mortalities at 2, 5 and 10 mL/kg were 0, 67 and 100 %, respectively. - Clinical signs:
- - None of the animals were showing symptoms at 2 h after treatment.
- After 18 h, both mice dosed at 10.0 mL/kg bw and 4/6 mice dosed at 5.0 mL/kg bw were comatose, hypothermic, showing signs of stress and exhibiting laboured breathing. Two other mice dosed at 5.0 mL/kg bw appeared unaffected.
- Female mouse dosed at 2 mL/kg bw was showing signs of stress at 18 h after treatment, but recovered within 42 h. - Body weight:
- - Surviving animals gained weight during the 7 day observation period.
- Gross pathology:
- - Autopsy of the animals that died revealed gaseous distension of the stomach and irritation and gaseous distension of the duodenum and ileum with blood stained contents present.
- Where the stomach was in contact with the liver this organ appeared bleached and the mice also had pale kidneys.
- Other findings included congestion of the lungs, prominent distended gall bladders and distension of the bladder due to the presence of pale yellow urine.
- Surviving animals presented a normal appearance at autopsy. - Other findings:
- None
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 of PM 343 Pivaloxycyclene is higher than 2000 mg/kg bw in mice therefore it is not classified according to the Directive 67/548/EEC and the CLP Regulation.
- Executive summary:
In an acute oral toxicity study performed similarly to OECD Guideline 401, groups of mice were given a single oral dose of the test item, PM 343 Pivaloxycyclene, at 2, 5 and 10 mL/kg bw. Numbers of animals in the respective group were 1, 3 and 1 mice/sex/dose. Animals were observed for mortality, clinical signs and bodyweights for 7 days and were all macroscopically necropsied after sacrifice.
Mortalities at 2, 5 and 10 mL/kg were 0, 67 and 100 %, respectively. Surviving animals gained weight during the 7 day observation period and presented a normal appearance at autopsy. None of the animals were showing symptoms at 2 h after treatment. After 18 h, both mice dosed at 10.0 mL/kg bw and 4/6 mice dosed at 5.0 mL/kg bw were comatose, hypothermic, showing signs of stress and exhibiting laboured breathing. Two other mice dosed at 5.0 mL/kg bw appeared unaffected. Female mouse dosed at 2 mL/kg bw was showing signs of stress at 18 h after treatment, but recovered within 42 h. Autopsy of the animals that died revealed gaseous distension of the stomach and irritation and gaseous distension of the duodenum and ileum with blood stained contents present. Where the stomach was in contact with the liver this organ appeared bleached and the mice also had pale kidneys. Other findings included congestion of the lungs, prominent distended gall bladders and distension of the bladder due to the presence of pale yellow urine. In this study, the combined oral LD50 of the test item, PM 343 Pivaloxycyclene, in mice was considered to be approximately 5 mL/kg bw [equivalent to 5330 mg/kg bw; calculated using the density of 1.066 g/L (literature)].
The oral LD50 of PM 343 Pivaloxycyclene is higher than 2000 mg/kg bw in mice therefore it is not classified according to the Directive 67/548/EEC and the CLP Regulation.
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.