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Diss Factsheets
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EC number: 207-431-5 | CAS number: 470-82-6
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- Between 25th March and 8th April 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- To address toxicological endpoints as part of the REACH registration of Cineole (Target Substance) it is proposed to read-across to Clarycet (Source Substance). The use of read-across works within the spirit of REACH and the stated aim of the legislation to reduce animal testing where possible. The Target Substance and Source Substance have been characterised in using the categories and databases present in the OECD (Q)SAR Toolbox. From the profile, it can be seen that the two substances share structural similarities and also "mechanistic action" similarities which are both general and endpoint specific. Therefore read-across is justified.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Clarycet
- IUPAC Name:
- Clarycet
- Reference substance name:
- 131766-73-9
- EC Number:
- 603-508-6
- Cas Number:
- 131766-73-9
- IUPAC Name:
- 131766-73-9
- Reference substance name:
- Tetrahydro-4-methyl-2-propyl-2H-pyran-4-yl acetate
- IUPAC Name:
- Tetrahydro-4-methyl-2-propyl-2H-pyran-4-yl acetate
- Details on test material:
- - Name of test material (as cited in study report): Clarycet (2H-Pyran-4-ol, tetrahydro-4-methyl-2-propyl acetate)
- Molecular weight (if other than submission substance): 200.28
- Smiles notation (if other than submission substance): C1(C)(OC(C)=O)CC(CCC)OCC1
- Structural formula attached as image file (if other than submission substance): see Fig.
- Physical state: Liquid
- Analytical purity: >94 %
- Impurities (identity and conce
- Lot/batch No.: 6370
- Storage condition of test material: Room temperature in the dark
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Ltd., Margate, Kent, England.
- Age at study initiation: 7 - 10 weeks
- Weight at study initiation: 216 - 244 g
- Fasting period before study:
- Housing: Individually in metal cages with wire mesh floors.
- Diet (e.g. ad libitum): Standard laboratory rodent diet ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Minimum period of 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Daily mean minimum and maximum temperatures were 21 - 23 °C
- Humidity (%): 54 % RH
- Air changes (per hr): 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light/dark
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 50 mm x 50 mm
- % coverage: 10 %
- Type of wrap if used: Gauze held in place with an impenetrable dressing encircled firmly around the trunk.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Skin was decontaminated usign warm water 30 - 40 °C and blotting dry with absorbent paper.
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.04 mL/kg body weight (specific gravity 0.98).
- Concentration (if solution): 2 g/kg bw
VEHICLE
- Amount(s) applied (volume or weight with unit): Not applicable
- Concentration (if solution): Not applicable
- Lot/batch no. (if required): Not applicable
- Purity: Not applicable - Duration of exposure:
- 24 h
- Doses:
- 2 g/kg bw
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1 (a period of 5 hours). On subsequent days the animals were observed once in the morning and again at the end of the experimental day.
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs, including the nature, severity, approximate time of onset and duration of each sign. Individual body weight of rats on Days 1 (day of dosing), 8 and 15.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 other: g/kg bodyweight
- Based on:
- test mat.
- Remarks on result:
- other: There were no deaths following exposure
- Mortality:
- There were no deaths following a single dermal dose of the test substance at 2 g/kg bodyweight.
- Clinical signs:
- other: There were no signs of systemic reaction. Sites of application of the test substance showed no irritation or other dermal changes (scores of zero of erythema and oedema were recorded for all animals).
- Gross pathology:
- Terminal autopsy revealed no macroscopic abnirmalities.
Any other information on results incl. tables
To address toxicological endpoints as part of the REACH registration of Cineole (Target Substance) it is proposed to read-across to Clarycet (Source Substance).
The use of read-across works within the spirit of REACH and the stated aim of the legislation to reduce animal testing where possible.
The Target Substance and Source Substance have been characterised in using the categories and databases present in the OECD (Q)SAR Toolbox. From the profile, it can be seen that the two substances share structural similarities and also "mechanistic action" similarities which are both general and endpoint specific.
Therefore read-across is justified.
See Section 13, document Read Across Justification_Clarycet.
Applicant's summary and conclusion
- Conclusions:
- The results of an acute dermal toxicity study on the structural analogue, Clarycet, are provided as part of a weight of evidence. The acute lethal dermal dose to rats of the test substance was found to be > 2.0 g/kg bodyweight.
- Executive summary:
An acute dermal toxicity study was performed according to OECD Guideline for Testing of Chemicals 402 "Acute Dermal Toxicity", and EEC Methods for the determination of toxcity, Directives 84/449/EEC (OJ No. L251, 19.9.84), Part B, Method B3. Acute Toxicity (Dermal).
The acute lethal dermal dose to rats of the test substance was found to be > 2.0 g/kg bodyweight.
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.
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