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EC number: 291-807-9 | CAS number: 90480-71-0
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1996/04/09-1996/04/13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to an OECD test guideline and in compliance with GLP. The study is a read across from hexadecanol (CAS 36653-82-4).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Hexadecan-1-ol
- EC Number:
- 253-149-0
- EC Name:
- Hexadecan-1-ol
- Cas Number:
- 36653-82-4
- IUPAC Name:
- hexadecan-1-ol
- Details on test material:
- - Name of test material (as cited in study report): KALCHOL 6098
- Physical state: white granular solid
- Lot/batch No.: 2439
- Storage condition of test material: room temperature in the dark
- Other: Data relating to the identity, purity and stability of the test material are the responsibility of the sponsor.
Constituent 1
Test animals / tissue source
- Species:
- other: New Zealand White rabbit
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.69-3.01kg
- Housing: The animals were individually housed in suspended metal cages.
- Diet: STANRAB SQC Rabbit Diet, Special Diets Services Ltd, Witham, Essex, UK (ad libitum)
- Water: tap water (ad libitum)
- Acclimation period: minimum of five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-19C
- Humidity (%): 56-61%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12h/12h
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The other eye of each rabbit was used as a control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A volume of 0.1ml of the test material which was found to weight approximately78mg was applied to the eye.
VEHICLE
-No vehicle. - Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 1h, 24h, 48h, 72h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No washing reported.
SCORING SYSTEM: Draize J H (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the toxicity of Household Substances,National Academy of Sciences, Washington DC p. 48 to 49. Classification According to a Modified Version of the Kay and Calandra System
TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by the use of the light source from a standard opthalmoscope.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: mean 24,48,72h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- other: Iridial inflammation
- Basis:
- animal #1
- Time point:
- other: mean 24,48,72h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No initial effect.
- Irritation parameter:
- other: Conjunctival redness
- Basis:
- animal #1
- Time point:
- other: mean 24h,48h,72h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- other: Conjunctival chemosis
- Basis:
- animal #1
- Time point:
- other: mean 24,48,72h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: mean 24,48,72h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No initial effect.
- Irritation parameter:
- other: Iridial infalmmation
- Basis:
- animal #2
- Time point:
- other: mean 24,48,72h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No initial effect.
- Irritation parameter:
- other: Conjunctival redness
- Basis:
- animal #2
- Time point:
- other: mean 24,48,72h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- other: Conjunctival chemosis
- Basis:
- animal #2
- Time point:
- other: mean 24,48,72h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- other: No initial effect.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: mean 24,48,72h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No initial effect.
- Irritation parameter:
- other: Iridial inflammation.
- Basis:
- animal #3
- Time point:
- other: mean 24,48,72h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No initial effect.
- Irritation parameter:
- other: Conjunctival redness
- Basis:
- animal #3
- Time point:
- other: mean 24, 48,72h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- other: Conjunctival chemosis
- Basis:
- animal #3
- Time point:
- other: mean 24,48,72h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No initial effect.
- Irritant / corrosive response data:
- The numerical values corresponding to each animal, tissue and observation time were recorded. The data relating to the conjunctivae were designated by the letters A (redness), B (chemosis) and C (discharge), those relating to the iris designated by the letter D and those relating to the cornea by the letter E (degree of opacity) and F (area of opacity). For each tissue the score was calculated as follows:
Score for the conjunctivae - (A+B+C)x2
Score for iris - Dx5
Score for cornea - (ExF)x5
Using the numerical data obtained a modified version of the system described by Kay J H and Calandra J C, J.Soc.Cosmet Chem., 1962 13 281-289 wasused to classify the ocular irritancy potential of the test material. This was achieved by adding together the scores for the cornea, iris and conjunctivae for each time point for each rabbit. The group means of the total scores for each observation were calculated. If any rabbit shows irreversible oculardamage the test material will be classified as corrosive to the eye.
Overall irritation score: Maximum group mean score 15.3 at 1 hour post instillation. Classified as a mild irritant according to a modified Kay and
Calandra system. - Other effects:
- DESCRIPTION OF LESIONS: Dulling of the cornea noted in 2 animals 1 hour after instillation, diffuse corneal opacity noted in 1 rabbit at 24 hours
post instillation. Iridial inflammation noted in 2 animals at 1 hour post instillation only. Moderate conjunctival irritation noted in all eyes at 1 hour
which reduced to minimal conjunctival irritation at 24 hours.
REVERSIBILITY: All eyes were normal at 48 and 72 hours post instillation.
OTHER EFFECTS: Residual test material noted around the treated eyes at 1 hour post instillation.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Kalcol 6098 is not an eye irritant according to EU or GHS criteria.
The result is a read across from hexadecanol (CAS 36653-82-4).
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