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EC number: 427-900-1 | CAS number: 198404-98-7
- 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
- Study period:
- From 17 September to 25 September 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
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
Test material
- Reference substance name:
- Cyclopropanemethanol, 1-methyl-2-[[(1S,3R,5R)- 1,2,2-trimethylbicyclo[3.1.0]hex-3-yl]methyl]-, (1S,2S)-, rel-
- Molecular formula:
- C15H26O
- IUPAC Name:
- Cyclopropanemethanol, 1-methyl-2-[[(1S,3R,5R)- 1,2,2-trimethylbicyclo[3.1.0]hex-3-yl]methyl]-, (1S,2S)-, rel-
- Reference substance name:
- Cyclopropanemethanol, 1-methyl-2-[[(1S,3R,5R)- 1,2,2-trimethylbicyclo[3.1.0]hex-3-yl]methyl]-, (1R,2R)-, rel-
- Molecular formula:
- C15H26O
- IUPAC Name:
- Cyclopropanemethanol, 1-methyl-2-[[(1S,3R,5R)- 1,2,2-trimethylbicyclo[3.1.0]hex-3-yl]methyl]-, (1R,2R)-, rel-
- Test material form:
- liquid
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Javanol
- Physical state: Pale yellow viscous liquid
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH - Birkendorferstrasse 65 - D-88397 Biberach/Riss
- Age at study initiation: 12 weeks
- Weight at study initiation:
Male: 2679 g
Female: 2940 and 2862 g
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): Pelleted standard Kliba 341, ad libitum
- Water (e.g. ad libitum):Community tap water from Itingen, ad libitum
- Acclimation period: four days under test conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 40-70%
- Air changes (per hr): 10-115
- Photoperiod (hrs dark / hrs light): 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.1 ml per animal of Javanol was applied undiluted as it was delivered by the sponsor
- Duration of treatment / exposure:
- On the day of treatment, the test article undiluted 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 a control.
- Observation period (in vivo):
- The ocular reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992 at approximately 1, 24, 48 and 72 hours after administration
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): None
SCORING SYSTEM:
The ocular reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992 at approximately 1, 24, 48 and 72 hours, as well as 7 days after application.
TOOL USED TO ASSESS SCORE: Eye examinations were made with a Varta Cliptrix diagnostic-lamp (A. Riegger, Basel / Switzerland).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 22
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 23
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 24
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: 22
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal: 23
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal: 24
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 22
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 23
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 24
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal: 22
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal: 23
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal: 24
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- Irritation: Application of the test article to healthy rabbit conjunctivae resulted in a primary eye irritation score of 0.78. Slight to moderate reddening and sweling of the conjunctivae were noted in all animals after one hour. Slight to moderate reddening of the conjunctivae persisted in all animals after 24 hours and in one animal after 48 hours. Moderate watery discharge was evident in all animals, as was hyperemia of the scleral blood vessels. All findings were reversible after 72 hours.
Corrosion: No corrosion of the cornea was observed at any of the reading times. - Other effects:
- Coloration: No staining of the cornea, sclera or conjunctivae by the test article was observed.
Body weights: The body weight of all rabbits were considered to be within the normal range of viariability.
Any other information on results incl. tables
Eye irritation score - individual values:
Animal number | sex | Evaluation interval | Corneal opacity | Iris | conjunctivae | cumulative | ||
Redness | Chemosis | Score | Mean | |||||
22 23 24 |
M F |
1 hour | 0 0 0 |
0 0 0 |
2 2 2 |
1 1 1 |
3.00 3.00 3.00 |
3.00 |
22 23 24 |
M F F |
24 hours | 0 0 0 |
0 0 0 |
0 0 2 |
1 1 2 |
1.00 1.00 4.00 |
2.00 |
22 23 24 |
M F F |
48 hours | 0 0 0 |
0 0 0 |
0 0 1 |
0 0 0 |
0.00 0.00 1.00 |
0.33 |
22 23 24 |
M F F |
72 hours | 0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0.00 0.00 0.00 |
0.00 |
Eye irritation scores - mean values after 24, 48 and 72 hours:
Animal number | Sex | Cornea opacity | N | Iris | N | Conjunctivae | Primary eye irritation score | |||
Redness | N | Chemosis | N | |||||||
22 23 24 |
M F F |
0.00 0.00 0.00 |
3 3 3 |
0.00 0.00 0.00 |
3 3 3 |
0.00 0.00 1.00 |
3 3 3 |
0.33 0.33 0.67 |
3 3 3 |
0.78 |
Mean score | 0.00 | 0.00 | 0.44 | 0.00 |
N = number of available data points
Eye irritation scores - assessment according to EC guidelines:
Evaluated intervals | Corneal opacity | Iris | Conjunctivae | |
Redness | Chemosis | |||
24 hours 48 hours 72 hours |
Not irritating | Not irritating | Not irritating | Not irritating |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the referred classification criteria, Javanol is considered to be 'not irritating' to the rabbit eye.
- Executive summary:
A key eye irritation study was performed according to OECD guideline 405 (adopted 1987), EEC Commission Directive 92/69/EEC (1992) and in compliance with GLP.
The primary eye irritation potential of the test article was investigated by instillation of 0.1 mL into one eye of each of three young adult New Zealand White rabbits. The treated eyes were not ronsed after application. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test article application. The scores of each animal at the following reading times (24, 48 and 72 hours) were used in calculating the respective mean values for each type of lesion. The primary irritation score was calculated by totalling the individual cumulative scores at 24, 48 and 72 hours and then divding the resulting total by the number of data points. The primary irritation score was 0.78 (max. 13). Reddening and/or swelling the conjunctivae were noted in all animals after 24 hours. Reddening was noted after 48 hours in one animal only. Watery discharge and hyperemia of the sclera blood vessels were seen in all animals after one hour. All findings were reversible after 72 hours.
No staining of the sclera, conjunctivae and cornea of the treated eyes by the test article was observed. No corrosion was observed at any measuring intervals. Under the conditions of the this test, Javanol is not considered to be an eye irritant.
Based upon the test results and in accordance to the Regulation (EC) No 1272/2008 (CLP) and Globally Harmonized System of Classification and Labeling of Chemicals (GHS), Javanol is not classified.
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