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EC number: 412-450-9 | CAS number: 131766-73-9 CLARYCET
- 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:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducting according to OECD method by a GLP accredited laboratory.
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Directive 84/449/EEC, Annex V, Method B5 and OECD guideline for Toxicity Testing of Chemicals, No. 405.
- GLP compliance:
- yes
Test material
- Reference substance name:
- A mixture of: trans-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran; cis-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran
- EC Number:
- 412-450-9
- EC Name:
- A mixture of: trans-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran; cis-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran
- Cas Number:
- 131766-73-9
- Molecular formula:
- C11H20O3
- IUPAC Name:
- reaction mass of: trans-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran cis-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Three healthy female adult rabbits of the New Zealand White strain were used. Animals weighed 3.6-4.4 kg and were approximately 14 to 16 weeks of age prior to treatment (Day 1). Animals were individually housed in metal cages with perforated floors. Animals had free access to drinking water and SDS Stanrab (P) Rabbit Diet. Animal room temperature was maintained a mean maximum of 18.2°C and a mean minimum of 18.1°C. Mean relative humidity was 50.5%. Air exhange was maintained at approximately 19 air changes per hour and lighting was controlled to give 12 hours light and 12 hours dark in each 24 hour period.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The contralateral eye of the animal remained untreated.
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- After instillation, the test substance remained in the eye.
- Observation period (in vivo):
- Examination of the eyes was made after 1 hour and 1, 2, 3, 4 and 7 days after instillation.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- The eyes of each animal were examined prior to instillation of the test material to ensure that there was no pre-existing corneal damage, iridal or conjunctival inflammation. A 0.1 ml aliquot of the test material was placed into the lower everted lid of one eye of each animal. The eyelids were then gently held together for one second before releasing. The contralateral eye remained untreated and served as a control. All animals were observed daily for signs of ill health or toxic signs. Examination of the eyes was made after 1 hour and 1, 2, 3, 4 and 7 days after instillation. Observation of the eyes was aided by the use of a handheld light. Grading and scoring of ocular lesions were performed using a numerical scoring system 0-4 for the cornea, iris, conjunctivae and chemosis
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Remarks:
- (mean score 2)
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritant / corrosive response data:
- Corneal opacities developed 1 or 24 hours after instillation in all three animals. The responses persisted 1, 2 or 3 days before resolving. A diffuse crimson-red colouration of the conjunctivae was observed in all three animals. This was accompanied in one animal by obvious swelling with partial eversion of the eyelids. All reactions had resolved four or seven days after instillation. Under the conditions of the study, instillation of 100% test substance into the rabbit eye elicited corneal opacification and slight conjunctival irritation.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the study, instillation of 100% test material into the rabbit eye elicited transient corneal opacification and slight conjunctival irritation. The test substance does not require labelling for eye irritation.
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