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Diss Factsheets
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EC number: 201-219-6 | CAS number: 79-69-6
- 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:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- rel-(E)-4-((1R,5R)-2,5,6,6-tetramethylcyclohex-2-en-1-yl)but-3-en-2-one
- Cas Number:
- 599-45-1
- Molecular formula:
- C14H22O
- IUPAC Name:
- rel-(E)-4-((1R,5R)-2,5,6,6-tetramethylcyclohex-2-en-1-yl)but-3-en-2-one
- Reference substance name:
- rel-(E)-4-((1R,5S)-2,5,6,6-tetramethylcyclohex-2-en-1-yl)but-3-en-2-one
- Cas Number:
- 472-46-8
- Molecular formula:
- C14H22O
- IUPAC Name:
- rel-(E)-4-((1R,5S)-2,5,6,6-tetramethylcyclohex-2-en-1-yl)but-3-en-2-one
- Reference substance name:
- 3-Buten-2-one, 4-(2,5,6,6-tetramethyl-1-cyclohexen-1-yl)-, (3E)-
- Cas Number:
- 72074-84-1
- Molecular formula:
- C14H22O
- IUPAC Name:
- 3-Buten-2-one, 4-(2,5,6,6-tetramethyl-1-cyclohexen-1-yl)-, (3E)-
- Reference substance name:
- 3-Buten-2-one, 4-(2,2,3,6-tetramethyl-3-cyclohexen-1-yl)-, [1α(E),6α]-
- Cas Number:
- 140632-46-8
- Molecular formula:
- C14H22O
- IUPAC Name:
- 3-Buten-2-one, 4-(2,2,3,6-tetramethyl-3-cyclohexen-1-yl)-, [1α(E),6α]-
- Reference substance name:
- 4-Penten-2-one, 5-(1,3,4-trimethyl-3-cyclohexen-1-yl)-, (E)-
- Cas Number:
- 162282-94-2
- Molecular formula:
- C14H22O
- IUPAC Name:
- 4-Penten-2-one, 5-(1,3,4-trimethyl-3-cyclohexen-1-yl)-, (E)-
Constituent 1
Constituent 2
impurity 1
impurity 2
impurity 3
- Specific details on test material used for the study:
- Identification: Irone Alpha
Description: pale yellow liquid
Batch Number 9000372727
Stability of test item: Stable under storage conditions, expiration date 17-Feb-2002
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Rationale: Recognized by the international guidelines as the recommended test system
Source: Elevage Scienfitique des Dombes, F-01400 Chatillon sur Charlaronne / France
Number of Animals: 1 male and 2 females
Age at start of treatment: 14 weeks (male), 12 and 13 weeks (females)
Body weights at start of treatment: 2.8 - 3.1 kg
Identification: By unique cage number and corresponding ear number
Acclimatization: Five to six days under laboratory conditions after health examination. Only anomals without any visual signs of illness were used for the study.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 ml / animal
- Duration of treatment / exposure:
- The treated eyes were not rinsed after instillation.
- Observation period (in vivo):
- 1, 24, 48 and 72 hours as well as 7 days after application.
- Number of animals or in vitro replicates:
- 1 male and 2 females
- Details on study design:
- Treatment
The eyes of the animals were examined one day prior to test item administration.
Animals with overt signs of ocular injury or irritation which may have interfered with the interpretation of the results were not used in the test.
On the day of treatment, Irone Alpha was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of test item. The right eye remained untreated and served as the reference control. The treated eyes were not rinsed after instillation.
Observations
Viability/Mortality: Daily from delivery of the animals to the termination of test
Clinical signs: Daily from delivery of the animals to the termination of test
Body weights: At the start of acclimatization, on the day of application and at termination of observation
Irritation Scores
The ocular reaction was assessed according to the numerical scoring system listed in the EEC Commision Directive 92/69/EEC, July 31, 1992 at approximately 1, 24, 48 and 72 hours as well as 7 days after application.
Necropsy
All rabbits were sacrificed by an intravenous injection of NARCOREN into the ear at a dose of at least 1 ml/kg bosy weight and discarded.
No necropsy was performed on the animals sacrificed at termination of observation.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.11
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No corneal and iridal effects were observed. Some blood vessels of the conjunctivae/nictitating membrane were definitely hyperemic in all animals at the 1-hour reading. The slight redness was still observeed in one animal at the 24 hours. Slight swelling of the conjunctivae/nictitating membrane was still observed in all animals at the 1-hour reading. A slight redness of the sclera was seen n all animals at the 1- and 24- hour reading. It persisted in one animal at the 48 and 72 hurs, A slight watery discharge was noted on one animal at the 1-hour reading. All eye reactions were clear within 7 days after treatment.
- Other effects:
- No staining of treated eyes was observed.
No corrosion of the cornea was observed at any of the reading times.
The body weights of all the rabbits were considered to be within the normal range of variability.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based upon the referred classification criteria (EEC Commision Directive 93/21/EEC of April 27, 1993), Irone Alpha is considered to be 'not irritating' to the rabbit eye.
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