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Diss Factsheets
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EC number: 200-624-5 | CAS number: 66-25-1
- 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 vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018-03-01 to 2018-03-01
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- OGYEI, Budapest (21.04.2016)
Test material
- Reference substance name:
- Hexanal
- EC Number:
- 200-624-5
- EC Name:
- Hexanal
- Cas Number:
- 66-25-1
- Molecular formula:
- C6H12O
- IUPAC Name:
- hexanal
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- Water
- Reference substance name:
- 3,4-dihydro-2,5,7,8-tetramethyl-2-(4,8,12-trimethyltridecyl)-2H-benzopyran-6-ol
- EC Number:
- 233-466-0
- EC Name:
- 3,4-dihydro-2,5,7,8-tetramethyl-2-(4,8,12-trimethyltridecyl)-2H-benzopyran-6-ol
- Cas Number:
- 10191-41-0
- Molecular formula:
- C29H50O2
- IUPAC Name:
- 2,5,7,8-tetramethyl-2-(4,8,12-trimethyltridecyl)chroman-6-ol
- Test material form:
- liquid
- Details on test material:
- - State of aggregation: clear liquid
Constituent 1
impurity 1
additive 1
Test animals / tissue source
- Species:
- chicken
- Strain:
- other: ROSS 308
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: TARAVIS KFT. 9600 Sárvár, Rábasömjéni út 129. Hungary
- indication of any existing defects or lesions in ocular tissue samples: the selected eyes were examined with the slit lamp microscope to ensure that they were in good condition. The focus was adjusted to see clearly the isotonic saline which was flowing on the cornea surface. Eyes with a high baseline fluorescein staining (i.e., > 0.5) or corneal opacity score (i.e., > 0.5) were rejected.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 30 µL
- Duration of treatment / exposure:
- 10 seconds exposure
- Duration of post- treatment incubation (in vitro):
- up to 240 minutes after the post-treatment rinse
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SELECTION AND PREPARATION OF ISOLATED EYES
: The eyeball was carefully removed from the orbit by holding the nictitating membrane with surgical forceps, while cutting the eye muscles with bent scissors. Care was taken to remove the eyeball from the orbit without cutting off the optical nerve too short. The procedure avoided pressure on the eye while removing the eyeball from the orbit, in order to prevent distortion of the cornea and subsequent corneal opacity. Once removed from the orbit, the eye was placed onto damp paper and the nictitating membrane was cut away with other connective tissue. The prepared eyes were kept on the wet papers in a closed box so that the appropriate humidity was maintained.
EQUILIBRATION AND BASELINE RECORDINGS : At the end of the acclimatization period, a zero reference measurement was recorded for cornea thickness and opacity to serve as a baseline (t=0) for each individual eye. The cornea thickness of the eyes should not change by more than ±5-7 % within approximately 45 to 60 minutes before the start of application. Slight changes in thickness (0 % to 2 %) were observed in the eyes, finding considered as normal when maintaining enucleated eyes. Following the equilibration period, the fluorescein retention was measured. Baseline values were required to evaluate any potential test item related effects after treatment. The location of any minor findings was marked on the record sheet as a drawing, if applicable. If any eye was considered to be unsuitable following baseline assessment, it was discarded.
NUMBER OF REPLICATES : test item: 3, positive control: 3, negative control: 1
NEGATIVE CONTROL USED : NaCl, 9 g/L saline
POSITIVE CONTROL USED: Acetic acid, 10 % (v/v)
APPLICATION DOSE AND EXPOSURE TIME : 30 µl, 10 seconds exposure
OBSERVATION PERIOD : 240 min
REMOVAL OF TEST SUBSTANCE
- Volume and washing procedure after exposure period: 20 ml saline solution
SCORING SYSTEM:
- Mean corneal swelling (%)
- Mean maximum opacity score
- Mean fluorescein retention score at 30 minutes post-treatment
DECISION CRITERIA: decision criteria as indicated in the TG were used.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- percent corneal swelling
- Value:
- >= 14 - <= 18
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- cornea opacity score
- Value:
- 1.7
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- fluorescein retention score
- Value:
- 0.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- other: overall ICE Class
- Remarks on result:
- other: 1x I, 2x III
Any other information on results incl. tables
Test Item: Hexanal
Observation |
Value |
ICE Class |
Mean maximum corneal swelling at up to 75 min |
14 % |
III |
Mean maximum corneal swelling at up to 240 min |
18 % |
II |
Mean maximum corneal opacity |
1.7 |
III |
Mean fluorescein retention |
0.5 |
I |
Other Observations |
None |
|
Overall ICE Class |
1xI, 2xIII |
Applicant's summary and conclusion
- Interpretation of results:
- other:
- Remarks:
- Not ocular corrosive (not Cat. 1). The assay does not allow a conclusion regarding ocular irritation (Cat. 2)
- Conclusions:
- In this ICET, hexanal did not cause ocular corrosion or severe irritation in the enucleated chicken eye. The overall ICE score was 1xI, 2xIII.
Positive and negative controls showed the expected results. The experiment was considered to be valid. - Executive summary:
The severe eye irritation potential of the test item hexanal was analysed in an Isolated Chicken Eye Test (ICET) according to OECD TG 438 under GLP conditions. Isolated chicken eyes were exposed to 30 µL of undiluted hexanal for 10 seconds, followed by a post-treatment observation period of up to 240 min. In this ICET, hexanal did not cause ocular corrosion or severe irritation in the enucleated chicken eyes. The overall ICE score was 1xI, 2xIII. Positive and negative controls showed the expected results. The experiment was considered to be valid.
According to the OECD TG 438, the overall classification of hexanal is neither UN GHS Category I (an ocular corrosive or severe eye irritant) nor No Category.
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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