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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- Between 02 April 1991 and 15 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:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
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: Clear colourless liquid
- Analytical purity: > 94 %
- Lot/batch No.: 6370
- Storage condition of test material: Room temperature in the dark
Constituent 1
Constituent 2
Constituent 3
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: froxfield Farms (UK) Ltd, Petersfield, Hampshire, England.
- Age at study initiation: 14 - 16 weeks
- Weight at study initiation: 3.6 to 4.4 kg
- Housing: Individually in metal cages with perforated floors.
- Diet (e.g. ad libitum): SDS Stanrab (P) diet ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Acclimated for unspecified time period.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Mean maximum: 8.2 °C; mean minimum: 18.1 °C
- Humidity (%): 50.5 %
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12 hours light/dark
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The contralateral eye remained untreated in each rabbit.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): - Duration of treatment / exposure:
- The test substance was not removed from the eye by washing.
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- Three
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not done.
- Time after start of exposure: Not applicable.
SCORING SYSTEM: See other information on materials and methods.
TOOL USED TO ASSESS SCORE: None specified
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 3.3
- Max. score:
- 13
- Reversibility:
- fully reversible within: 7 Days
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: Day 1
- Score:
- 5
- Max. score:
- 13
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: Day 7
- Score:
- 0
- Max. score:
- 13
- Reversibility:
- fully reversible
Any other information on results incl. tables
Corneal opactities had developed one or 24 hours (1 day) after instillation in all three animals. The responses persisted up to three days before resolving.
A diffuse crimson-red colouration of the conjunctivae in all three animals. This was accompanied in one animal by obvious swelling with partial everson of the eyelid.
All reactions had resolved four or seven days after instillation.
Ocular reactions elicited by the test substance:
Rabbit No. and Sex |
Region of the eye |
One hour |
Days after instillation |
|||||
1 |
2 |
3 |
4 |
7 |
||||
587 F |
Cornea |
0 |
2 |
1 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
||
Conjunctiva |
Redness |
2 |
2 |
2 |
1 |
1 |
0 |
|
Chemosis |
2 |
2 |
1 |
1 |
0 |
0 |
||
588 F |
Cornea |
0 |
1 |
1 |
1 |
1 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
||
Conjunctiva |
Redness |
2 |
2 |
2 |
2 |
2 |
0 |
|
Chemosis |
1 |
|
1 |
1 |
1 |
0 |
||
629 F |
Cornea |
1 |
2 |
1 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
||
Conjunctiva |
Redness |
1 |
2 |
2 |
1 |
0 |
0 |
|
Chemosis |
1 |
1 |
1 |
0 |
0 |
0 |
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
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The results of an in vivo eye irritation study on the structural analogue, Clarycet, are provided as part of a weight of evidence. The test substance was assessed for eye irritation according to OECD 405. Instillation of the test substance into the rabbit eye elicited transient corneal opacification and slight conjunctival irritation. The test substance does not require labelling with the risk phrase R36 "irritating to eyes", as described in the EEC Directives 83/467/EEC and 86/43/EEC, Annex VI Part II(D).
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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