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EC number: 811-285-3 | CAS number: 1637294-12-2
- 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:
- Sep to Nov 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2012
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- 1998
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-[2-methyl-4-(2-methylpropyl)phenyl]propanal
- EC Number:
- 811-285-3
- Cas Number:
- 1637294-12-2
- Molecular formula:
- C14H20O
- IUPAC Name:
- 3-[2-methyl-4-(2-methylpropyl)phenyl]propanal
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Identification: NYMPHEAL
Appearance: Colourless to pale yellow liquid
Batch: SC00018060
Purity/Composition: See Certificate of Analysis
Test item storage: At room temperature protected from light
Stable under storage conditions until: 28 April 2017 (expiry date)
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Albino rabbit, New Zealand White, (SPF-Quality)
- Details on test animals or tissues and environmental conditions:
- Number of animals 3 Males
Age and body weight At start of dosing, the animals were between 12 and 24 weeks old and body weights were at least 1.5 kg.
Identification Earmark.
Health inspection At least prior to dosing. It was ensured that the animals were healthy and that the eyes were free from any abnormality.
Conditions
Environmental controls for the animal room were set to maintain 18 to 24°C, a relative humidity of 40 to 70%, at least 10 air changes/hour, and a 12-hour light/12-hour dark cycle. Any variations to these conditions were maintained in the raw data and had no effect on the outcome of the study.
Accommodation
Animals were individually housed in labeled cages with perforated floors (Ebeco, Germany, dimensions 67 x 62 x 55 cm) and shelters (Ebeco, Germany, dimensions 40 x 32 x 23 cm). Acclimatization period was at least 5 days before start of treatment under laboratory conditions.
Diet
Pelleted diet for rabbits (Global Diet 2030 from Harlan Teklad®, Mucedola, Milanese, Italy) approximately 100 grams per day. Hay (TecniLab-BMI BV, Someren, The Netherlands) and wooden sticks (Swedish aspen wood, Bioservices, Uden, The Netherlands) were available during the study period.
Water
Free access to tap water.
Diet, water, bedding and cage enrichment evaluation for contaminants and/or nutrients was performed according to facility standard procedures. There were no findings that could interfere with the study.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 0.1 mL of Nympheal (100%)
- Duration of treatment / exposure:
- Single samples of 0.1 mL of NYMPHEAL were instilled into one eye of each of three rabbits. Observations were made 1, 24, 48 and 72 hours and 7 days after instillation.
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3 male rabbits
- Details on study design:
- The study was performed in a stepwise manner and was started by treatment of a single rabbit (sentinel). The two other animals were treated in a similar manner 1 week later, after considering the degree of eye irritation observed in the first animal.
One hour prior to instillation of the test item, buprenorphine (Buprenodale®, Dechra Ltd., Stoke-on-Trent, United Kingdom) 0.01 mg/kg was administered by subcutaneous injection in order to provide a therapeutic level of systemic analgesia.
Five minutes prior to instillation of the test item, two drops of the topical anesthetic alcaine 0.5% (SA Alcon-Couvreur NV, Puurs, Belgium) were applied to both eyes.
Each animal was treated by instillation of 0.1 mL of the test item, in the conjunctival sac of one of the eyes after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test item. The other eye remained untreated and served as the reference control.
Immediately after the 24-hour observation, a solution of 2% fluorescein (Merck, Darmstadt, Germany) in water (adjusted to pH 7.0) was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage. This procedure was repeated to assess recovery. Any bright green stained area, indicating epithelial damage, was estimated as a percentage of the total corneal area.
Immediately after fluorescein examination on Day 2, in order to provide a continued level of systemic analgesia, buprenorphine 0.01 mg/kg and meloxicam (Metacam®, Boehringer Vetmed GmbH, Ingelheim/Rhein, Germany) 0.5 mg/kg were administered by subcutaneous injection.
After the final observation, the animals were sacrificed by intra-venous injection of Euthasol® 20% (AST Farma BV, Oudewater, The Netherlands).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 195
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal: 195
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 195
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: 195
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Reversibility:
- fully reversible within: 72hrs
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 211
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal: 211
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Reversibility:
- fully reversible within: 48hrs
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 211
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: 211
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 212
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal: 212
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 212
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: 212
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- Irritation
Instillation of 0.1 mL of NYMPHEAL into one eye of each of three rabbits resulted in effects on the cornea, iris and conjunctivae. The effects on the cornea consisted of slight dulling of the normal luster of the cornea and epithelial damage with an area of 25% in one animal only. The corneal injury resolved within 72 hours. Iridial irritation was observed 24 hours after installation for one animal only. The irritation of the conjunctivae consisted of redness, chemosis and discharge and completely resolved within 7 days in all animals.
Corrosion
There was no evidence of ocular corrosion. - Other effects:
- Coloration / Remnants
No staining of (peri) ocular tissues by the test item was observed and no test item remnants were seen.
Toxicity / Mortality
No signs of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Any other information on results incl. tables
List of Study Plan Deviations
1. Deviations from the maximum level of daily mean relative humidity occurred.
Evaluation: Laboratory historical data do not indicate an effect of the deviations.
The study integrity was not adversely affected by the deviation.
List of Standard Operating Procedures Deviations
Any deviations from standard operating procedures were evaluated and filed in the study file. There were no deviations from standard operating procedures that affected the integrity of the study.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Based on these results NYMPHEAL should be classified as Irritating to eyes (Category 2) according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).
- Executive summary:
SUMMARY
Acute eye irritation/corrosion study with NYMPHEAL in the rabbit.The study was carried out based on the guidelines described in: OECD No.405 (2012) "Acute Eye Irritation / Corrosion" EC, No 440/2008, B5: "Acute Toxicity: Eye Irritation/Corrosion" EPA, OPPTS 870.2400 (1998): "Acute Eye Irritation" JMAFF Guidelines (2000), including the most recent revisions. Single samples of 0.1 mL of NYMPHEAL were instilled into one eye of each of three rabbits. Observations were made 1, 24, 48 and 72 hours and 7 days after instillation. Instillation of NYMPHEAL into one eye of each of three rabbits resulted in effects on the cornea, iris and conjunctivae. The effects on the cornea consisted of slight dulling of the normal luster of the cornea and epithelial damage with an area of 25% in one animal only. The corneal injury resolved within 72 hours. Iridial irritation was observed 24 hours after installation for one animal only. The irritation of the conjunctivae consisted of redness, chemosis and discharge and completely resolved within 7 days in all animals.
Based on these results NYMPHEAL should be classified as Irritating to eyes (Category 2) according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).
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