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EC number: 422-120-6 | CAS number: 166432-53-7
- 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:
- 10-01-1995 to 27-01-1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study performed under GLP. All relevant validity criteria were met.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 422-120-6
- EC Name:
- -
- Cas Number:
- 166432-53-7
- Molecular formula:
- C14H22O
- IUPAC Name:
- 2-methyl-4-(2,2,3-trimethylcyclopent-3-en-1-yl)pent-4-enal
- Test material form:
- liquid
- Details on test material:
- - Physical state: Liquid
- Storage condition of test material: in the refrigerator in the dark
- Other: clear colourless liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Recognised animal supplier
- Age at study initiation: Young adult
- Weight at study initiation: 2.6 – 2.9 kg
- Housing: Individually housed in grid bottomed metal cages
- Diet: certified rabbit diet ad libitum (details in the full study report)
- Water: filtered certified water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 -21
- Humidity (%): 35 - 60
- Air changes (per hr): Not reported, however reported as air conditioned
- Photoperiod: 12 hours light / 12 hours dark
IN-LIFE DATES: From: 10-01-1995 To: 14-01-1995
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
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- A volume of 0.1 mL of the test item, was placed into the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for a few seconds immediately and then moved gently to distribute the test item around the surface of the eye. The left eye remained untreated (and was used for control purposes).
- Observation period (in vivo):
- Ocular assessment was conducted at approximately 1, 24, 48 and 72 hours after instillation of the test item, according to numerical evaluation.
- Number of animals or in vitro replicates:
- 3 (sex not specified).
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): None
- Time after start of exposure: Not applicable.
SCORING SYSTEM:
The irritation was assessed using criteria consistent with Draize (1977) numerical scoring system. At each observation period, each eye was assessed for damage or irritation to the cornea, iris and conjunctiva using the untreated eye as a control.
TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by the use of the light from a standard light source according to BS 950 (artifical daylight for the assessment of colour).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: mean; n=3
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: mean; n=3
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: mean; n=3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: mean; n=3
- Irritant / corrosive response data:
- No corneal or Iridial inflammation effects were noted. Very slight conjunctival reactions (redness, score = 1) was noted in treated eyes 1 hour after treatment. No chemosis effects were noted. All effects resolved within 24 hours observation.
- Other effects:
- - Lesions and clinical observations: None reported.
- Ophthalmoscopic findings: None reported.
- Histopathological findings: None reported.
- Effects of rinsing or washing: Not applicable.
- Other observations: None reported.
Any other information on results incl. tables
Table 1. Individual scores and mean scores for 24, 48 and 72 hours
Organism number and sex |
Time after treatment |
Corneal Opacity |
Iridial Inflammation |
Conjunctival Redness |
Conjunctival Chemosis |
1 (sex not specified) |
1h |
0 |
0 |
1 |
0 |
|
24 h |
0 |
0 |
0 |
0 |
|
48 h |
0 |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
0 |
|
Day 4 |
- |
- |
- |
- |
Mean (24 – 72 h) |
|
0.00 |
0.00 |
0.00 |
0.00 |
|
|
|
|
|
|
2 (sex not specified) |
1h |
0 |
0 |
1 |
0 |
|
24 h |
0 |
0 |
0 |
0 |
|
48 h |
0 |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
0 |
|
Day 4 |
- |
- |
- |
- |
Mean (24 – 72 h) |
|
0.00 |
0.00 |
0.00 |
0.00 |
|
|
|
|
|
|
3 (sex not specified) |
1h |
0 |
0 |
1 |
0 |
|
24 h |
0 |
0 |
0 |
0 |
|
48 h |
0 |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
0 |
|
Day 4 |
0 |
0 |
0 |
0 |
Mean (24 – 72 h) |
|
0.00 |
0.00 |
0.00 |
0.00 |
|
|
|
|
|
|
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study the test item is not irritating to the eye.
- Executive summary:
The study was performed to EU Method B.5 and/or a method equivalent or similar to OECD TG 405 under GLP to assess the irritancy potential of the test item to the eye following a single application in the New Zealand White rabbit. A volume of 0.1 ml of the test item was placed into the left eye of three animals sequentially using the first as a sentinel. The other eye remained untreated and was used for control purposes. Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment. A single application of the test item to the non-irrigated eye of three rabbits produced no corneal or Iridial inflammation effects. Slight conjunctival reaction (hyperaemia or redness, score = 1 and/or discharge, score = 1) was noted in treated eyes at 1 hour after treatment. No chemosis effects were noted. All treated eyes appeared normal at the 24 hours observation point. Under the conditions of this study, the test item is not considered to be irritating to the eye.
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