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Diss Factsheets
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EC number: 248-469-2 | CAS number: 27458-92-0
- 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:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Isotridecan-1-ol
- EC Number:
- 248-469-2
- EC Name:
- Isotridecan-1-ol
- Cas Number:
- 27458-92-0
- Molecular formula:
- C13H28O
- IUPAC Name:
- 2-methyldodecan-1-ol
- Details on test material:
- - Name of test substance: Tridecanol N
- Degree of purity: 99.9 %
- Physical state / appearance: Liquid / colorless-clear
- Lot/batch No.: continuous production
- Homogeneity: Homogeneous by visual inspection
- Storage conditions: Room temperature, covered with N2
- Stability under test conditions: The stability of the test substance in the vehicle for a time period of 4 hours was confirmed by analysis.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Centre Lago S.A., 01540 Vonnas, France
- Age at study initiation: About 4 months
- Weight at study initiation: 3.07 - 3.20 kg
- Housing: Single housing
- Diet: Kliba-Labordiaet, Provimi Kliba SA, Kaiseraugst, Switzerland (about 130 g/animal per day)
- Water: Tap water ad libitum
- Acclimation period: At least 5 days before the beginning of the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- 24 hour(s)
- Observation period (in vivo):
- 72 h (2 animals), 7 days (1 animal)
- Number of animals or in vitro replicates:
- 3 (2 females and 1 male)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): with tap water
- Time after start of exposure: 24 h
SCORING SYSTEM: according to OECD 405
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- (animal 1-3)
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: cornea opacity (score 1) only observed in one animal
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- (animal 1-3)
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects observed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- (animal 1-3)
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h - 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- (animal 1-3)
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: chemosis (score 1) observed in 3 animals
- Irritant / corrosive response data:
- Moderate conjunctival redness (grade 2), slight conjunctival chemosis (grade 1) and moderate to severe discharge (grade 2 - 3), were observed in all animals 1 hour after application.
Slight conjunctival redness (grade 1) was noted in 1 animal 24 and 48 hours after application. Moderate conjunctival redness (grade 2) was observed in 2 animals 24 hours after application and decreased to slight conjunctival redness (grade 1) after 48 hours after application. In one of these two animals slight conjunctival redness persisted up to 72 hours after application. Additionally slight corneal opacity (grade 1) and loss of corneal tissue was noted in this animal 48 and 72 hours after application.
The ocular reactions were reversible in 2 animals after 72 hours and in 1 animal within 7 days after application.
Mean scores calculated for each animal over 24, 48 and 72 hours were 0.0, 0 .7 and 0 .0 for corneal opacity, 0.0, 0.0 and 0.0 for iris lesions, 0.7, 1.3 and 1.0 for redness of the conjunctiva and 0.0, 0.0 and 0.0 for chemosis.
INDIVIDUAL OCULAR EXAMINATIONS AND MEAN VALUES
Readings Animal Cornea Iris Conjuntiva Additional Findings
Opacity Area of Redness Chemosis Discharge
cornea
involved
-------------------------------------------------------------------------------------------------------------------
1h 1 0 0 0 2 1 2
1h 2 0 0 0 2 1 3
1h 3 0 0 0 2 1 2
-------------------------------------------------------------------------------------------------------------------
24h 1 0 0 0 1 0 0
24h 2 0 0 0 2 0 0
24h 3 0 0 0 2 0 0
-------------------------------------------------------------------------------------------------------------------
48h 1 0 0 0 1 0 0
48h 2 1 1 0 1 0 0 LC
48h 3 0 0 0 1 0 0
-------------------------------------------------------------------------------------------------------------------
72h 1 0 0 0 0 0 0 SD
72h 2 1 1 0 1 0 0 LC
72h 3 0 0 0 0 0 0 SD
-------------------------------------------------------------------------------------------------------------------
7d 2 0 0 0 0 0 0
-------------------------------------------------------------------------------------------------------------------
Mean 1 0.0 0.0 0.7 0.0
Mean 2 0.7 0.0 1.3 0.0
Mean 3 0.0 0.0 1.0 0.0
-------------------------------------------------------------------------------------------------------------------
Mean 0.2 0.0 1.0 0.0
-------------------------------------------------------------------------------------------------------------------
Explanation of findings:
LC = Loss of corneal tissue
SD = Study discontinued because the animal was free of findings
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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