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EC number: 942-400-6 | 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
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- Nanomaterial pour density
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- Endpoint summary
- Stability
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- 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
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From October 02 to December 14, 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to the Draize procedure which is similar to the current OECD Test Guideline No. 405.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Study was performed according to modified Draize procedure (Draize, 1944).
- GLP compliance:
- no
- Remarks:
- (pre-GLP)
Test material
- Reference substance name:
- Reaction mass of (+-)-(1RS,2SR,5SR,7RS,8SR)-5-METHYLTRICYCLO[6.2.1.02,7]UNDECAN-4-ONE and (+-)-(1RS,2SR,5RS,7RS,8SR)-5-METHYLTRICYCLO[6.2.1.02,7]UNDECAN-4-ONE
- Molecular formula:
- C12H18O
- IUPAC Name:
- Reaction mass of (+-)-(1RS,2SR,5SR,7RS,8SR)-5-METHYLTRICYCLO[6.2.1.02,7]UNDECAN-4-ONE and (+-)-(1RS,2SR,5RS,7RS,8SR)-5-METHYLTRICYCLO[6.2.1.02,7]UNDECAN-4-ONE
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): 5. 0878/2
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Summit View Farm, Belvidere, New Jersey, USA
- Weight at study initiation: 1.8-2.4 kg
- Diet: Wayne animal feed, ad libitum
- Water: Water, ad libitum
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- The treated eyes of all animals remained unwashed for 24 h.
- Observation period (in vivo):
- Days 1, 2 and 3 following instillation of the test material.
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
SCORING SYSTEM: According to Draize scale.
TOOL USED TO ASSESS SCORE: Readings were facilitated by hand-held lenses.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- (6 animals)
- Time point:
- other: Mean 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- (6 animals)
- Time point:
- other: Mean 24, 48 and 72 h
- Score:
- 0.06
- Max. score:
- 2
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- (6 animals)
- Time point:
- other: Mean 24, 48 and 72 h
- Score:
- 0.28
- Max. score:
- 3
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- (6 animals)
- Time point:
- other: Mean 24, 48 and 72 h
- Score:
- 0.17
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritant / corrosive response data:
- - Animals showed weak conjunctival reactions (redness and chemosis) which were reversible within 2 days.
- One animal showed iris reaction of grade 1 which was reversible within 2 days. - Other effects:
- None
Any other information on results incl. tables
Table 7.3.2/1: Mean eye irritation response data of 6 animals at each observation time
Score at time point / Reversibility |
Cornea |
Iris (/2) |
Conjunctivae |
|||
Opacity (/4) |
Area (/4) |
Redness (/3) |
Chemosis (/4) |
Discharge (/3) |
||
Day 1 (24 h) |
0 |
0 |
0.17 |
0.83 |
0.5 |
0.17 |
Day 2 (48 h) |
0 |
0 |
0 |
0 |
0 |
0 |
Day 3 (72 h) |
0 |
0 |
0 |
0 |
0 |
0 |
Mean |
0 |
0 |
0.06 |
0.28 |
0.17 |
0.06 |
Reversibility |
- |
- |
- |
Completely reversible |
Completely reversible |
Completely reversible |
Average time for reversion |
- |
- |
- |
2 days |
2 days |
2 days |
Table 7.3.2/2: Eye irritation response data for each animal at each observation time
Score at time point |
Cornea |
Iris (/2) |
Conjunctivae |
|||
Opacity (/4) |
Area (/4) |
Redness (/3) |
Chemosis (/4) |
Discharge (/3) |
||
Day 1 (24 h) |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 1 / 0 / 0 |
1 / 1 / 1 / 1 / 1 / 0 |
1 / 1 / 0 / 1 / 0 / 0 |
0 / 0 / 0 / 1 / 0 / 0 |
Day 2 (48 h) |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
Day 3 (72 h) |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
Average 24, 48 and 72 h |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0.33 / 0 / 0 |
0.33 / 0.33 / 0.33 / 0.33 / 0.33 / 0 |
0.33 / 0.33 / 0 / 0.33 / 0 / 0 |
0 / 0 / 0 / 0.33 / 0 / 0 |
Reversibility |
- |
- |
Completely reversible |
Completely reversible |
Completely reversible |
Completely reversible |
Average time (unit) for reversion |
- |
- |
2 days |
2 days |
2 days |
2 days |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, the test material is not classified as irritating to the eyes according to the annex VI of the Regulation EC No. 1272/2008 (CLP).
- Executive summary:
In an eye irritation study performed according to the Draize procedure which is similar to the current OECD Test Guideline No. 405, 0.1 mL of undiluted test material was instilled into the right eye of 6 New Zealand White rabbits while the left eye remained untreated and served as control. The treated eyes of all animals remained unwashed for 24 h. Animals were observed at 24, 48 and 72 after instillation of test material into eyes. The reactions in the conjunctivae (redness, chemosis and discharge), the iris and the cornea (opacity and area involved) were scored according to the Draize Scale.
The calculated mean score for all animals within 3 scoring times (24, 48 and 72 h) were 0.28 for redness, 0.17 for chemosis, 0.06 for iris lesions and 0.0 for corneal opacity. The observed conjunctival reactions and iris lesion (max. score = 1) were fully reversible within 48 hours.
Under the test conditions, the test material is not classified as irritating to the eyes according to the annex VI of the Regulation EC No. 1272/2008 (CLP).
Although some details on experimental conditions were missing, this study is considered as acceptable and satisfies the requirement for eye irritation endpoint.
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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