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EC number: 251-718-8 | CAS number: 33885-52-8
- 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:
- 2015-09-01 till 2015-09-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- OECD 438 guideline study in compliance with GLP, available as unpublished report, no restrictions, fully adequate for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- TNO Triskelion, Utrechtseweg 48, 3700 AV, Zeist
Test material
- Reference substance name:
- α,α,6,6-tetramethylbicyclo[3.1.1]hept-2-ene-2-propionaldehyde
- EC Number:
- 251-718-8
- EC Name:
- α,α,6,6-tetramethylbicyclo[3.1.1]hept-2-ene-2-propionaldehyde
- Cas Number:
- 33885-52-8
- Molecular formula:
- C14H22O
- IUPAC Name:
- 3-{6,6-dimethylbicyclo[3.1.1]hept-2-en-2-yl}-2,2-dimethylpropanal
- Test material form:
- liquid
1
Test animals / tissue source
- Species:
- other: eyes of male or female chickens (ROSS, spring chickens)
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Slaughterhouse v.d. Bor, Nijkerkerveen, The Netherlands
- Age at study initiation: approximately 7 weeks
- Weight at study initiation: approximately 1.5 - 2.5 kg
- Heads of the animals were cut off immediately after sedation of the animals by electric shock and incision of the neck for bleeding, and before they reached the next station on the process line. The heads were placed in small plastic boxes on a bedding of paper tissues moistened with isotonic saline. Next they were transported to the testing facility. During transportation, the heads were kept at ambient temperature.
- The preparation and validation of the eyes prior to the ICE-test were all according to OECD guideline 438.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Positive controls: Benzalkonium Chloride. Negative control: Phosphate buffered saline (PBS).
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 30 µL - Duration of treatment / exposure:
- 10 seconds
- Observation period (in vivo):
- 0, 30, 75, 120, 180, and 240 minutes
- Number of animals or in vitro replicates:
- 3 eyes
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: The eyes were rinsed with 20 mL saline
- Time after start of exposure: 10 seconds
SCORING SYSTEM: According to OECD 438 guideline.
TOOL USED TO ASSESS SCORE: All examinations were carried out with the hand-slit lamp microscope. Fluorescein retention was only scored at approximately 30 minutes after treatment. After the final examination, the test substance treated eyes, the negative and positive control eyes were preserved in a neutral aqueous phosphate-buffered 4% solution of formaldehyde. The corneas were embedded in paraffin wax, sectioned at ca 4 μm and stained with PAS (Periodic Acid-Schiff). The microscopic slides were subjected to histopathological examination.
CONTROLS: A negative control (30 µL physiological saline) and 3 positive controls (30 µL Benzalkonium Chloride 5%) were included.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- mean 240 min
- Value:
- 4
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Maximum value during the test
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- mean 180 min
- Value:
- 0.7
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Maximum value during the test
- Irritation parameter:
- fluorescein retention score
- Run / experiment:
- mean 30 min
- Value:
- 0
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- Slit-lamp examination:
The test substance caused very slight corneal swelling (4%), very slight or slight opacity (mean score of 0.7) and no fluorescein retention (mean score of 0.0). The negative control eye did not show any corneal effect and demonstrated that the general conditions during the tests were adequate. The positive control BAC 5% caused severe corneal effects and demonstrated the ICE test valid to detect severe eye irritants
Microscopic examination:
Microscopic examination of the corneas treated with the test substance revealed very slight erosion (two corneas) and slight necrosis (one cornea) of the epithelium. Microscopic examination of the cornea treated with the negative control (saline) did not reveal any abnormalities, apart from very slight vacuolation (top region) of the epithelium. The positive control BAC 5% caused moderate or severe erosion, slight vacuolation (one cornea; low region) of the epithelium, and endothelial necrosis.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not an eye irritant
- Remarks:
- in accordance with EU CLP (EC 1272/2008 and its updates)
- Conclusions:
- Under the test conditions (OECD 438 and GLP) the test substance is not considered to be an eye irritant.
- Executive summary:
In accordance to OECD guideline 438 and GLP the test substance was examined for its in vitro eye irritating potential using the Isolated Chicken Eye (ICE) Test. In the ICE test, 3 eyes were exposed to 30 µL test substance for 10 seconds. In addition, one negative control eye (30 µL saline) and three positive control eyes (30 µL Benzalkonium Chloride (BAC)) were tested. After the exposure the eyes were rinsed with 20 mL saline and were examined at approximately 0, 30, 75, 120, 180, and 240 minutes after treatment. The test substance caused very slight corneal swelling (4%), very slight or slight opacity (mean score of 0.7) and no fluorescein retention (mean score of 0.0). The negative control eye did not show any corneal effect and demonstrated that the general conditions during the tests were adequate. The positive control BAC 5% caused severe corneal effects and demonstrated the ICE test valid to detect severe eye irritants. Microscopic examination of the corneas treated with Pinyl Iso Butyraldehyde revealed very slight erosion (two corneas) and slight necrosis (one cornea) of the epithelium. Microscopic examination of the cornea treated with the negative control (saline) did not reveal any abnormalities, apart from very slight vacuolation (top region) of the epithelium. The positive control BAC 5% caused moderate or severe erosion, slight vacuolation (one cornea; low region) of the epithelium, and endothelial necrosis. Based on these results the test substance is not considered to be an eye irritant.
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