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EC number: 617-182-8 | CAS number: 809282-20-0
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- April 24th, 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 2004/73/EC
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Benzenemethanol, α-[(1S)-2-(dimethylamino)-1-methylethyl]-α-ethyl-3-methoxy-, (αR)-
- Cas Number:
- 809282-20-0
- Molecular formula:
- C15H25NO2
- IUPAC Name:
- Benzenemethanol, α-[(1S)-2-(dimethylamino)-1-methylethyl]-α-ethyl-3-methoxy-, (αR)-
- Test material form:
- solid: crystalline
- Details on test material:
- white crystalline solid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- One female albino New Zealand rabbit was supplied by the Elevage de Gérome (Quartier Labaste – F40260 Linxe).
It was kept during a minimal 5-day acclimatisation period.
During the test, the animal weighed between 2.47 and 2.54 kg.
Each animal was kept in an individual box installed in a conventional air conditioned animal husbandry; the environmental conditions were:
- Temperature: between 20˚C and 23˚C
- Relative humidity: between 45% and 66%
Drinking water (tap-water from public distribution system) and foodstuff were supplied freely.
Microbiological and chemical analyses of the water were carried out every six months by the Institut Européen de l’Environnement de Bordeaux (I.E.E.B.).
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- Treatment: 0.1 g of the test item was instilled into the conjunctival sac of one eye, the other eye remained untreated serving as control.
Initially, a single animal was treated. After consideration of the ocular responses produced in the first treated animal, two additional animals were not treated. - Observation period (in vivo):
- 5 days
- Number of animals or in vitro replicates:
- Initially, a single animal was treated. After consideration of the ocular responses produced in the first treated animal, two additional animals were not treated.
- Details on study design:
- Treatment: 0.1 g of the test item was instilled into the conjunctival sac of one eye, the other eye remained untreated serving as control.
Initially, a single animal was treated. After consideration of the ocular responses produced in the first treated animal, two additional animals were not treated.
Grading of reactions:
Ocular examinations were performed on both right and left eyes 1 hour, 24, 48 and 72 hours following treatment, according to the numerical evaluation.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- The ocular reactions observed during the study have been moderate to severe and not reversible during 5 days of the test:
- At the conjunctivae: a moderate redness, noted 1 hour after the test item instillation and still noted at the end of the observation (D5), associated with a slight chemosis, noted 1 hour after the test item installation and still noted at the end of the observation (D5);
- At the corneal level: a moderate opacity, registered 24 hours after the test item instillation, and still noted at the end of the observation (D5);
- At the iris level: a congestion was noted the 2nd day of the test;
It was noted an ulceration on the nictitating membrane from the 1st day of the test. This lesion persisted for 72 hours.
Taking into account the severity of the reactions, the test was stopped the 5th day of the test, in accordance with the principles of animal welfare.
Any other information on results incl. tables
Time after treatment |
Conjunctivae Chemosis (A) |
Conjunctivae Discharge (B) |
Conjunctivae Redness (C) |
Iris Lesion (D) |
Cornea Opacity (E) |
Cornea Opacity (F) |
1 hour |
1 |
1 |
2 |
0 |
1 |
3 |
24 hours | 1 | 0 | 2 | 1 | 2 | 3 |
48 hours | 1 | 0 | 2 | 0 | 2 | 3 |
72 hours | 1 | 0 | 2 | 0 | 2 | 2 |
Day 4 (D4) | 1 | 0 | 2 | 0 | 2 | 1 |
Total (24, 48 & 72 hours) |
3 | 6 | 1 | 6 | ||
Mean (24, 48 & 72 hours) |
1.0 |
2.0 |
0.3 |
2.0 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The results obtained, under these experimental conditions, enable to conclude that the test item T2955 needs to be classified as causing serious eyes damage (eye damage cat. 1; H318 Causes serious eye damage).
- Executive summary:
Summary:
The test item T2955 was instilled, into the eye of one New Zealand rabbit at the dose of 0.1 g. The experimental protocol was established on the basis of the official method as defined in the OECD guideline no 405 dated April 24th, 2002 and the test method B.5 of the directive 2004/73/EC.
The ocular reactions observed during the study have been moderate to severe and not reversible during 5 days of the test:
- At the conjunctivae: a moderate redness, noted 1 hour after the test item instillation and still noted at the end of the observation (D5), associated with a slight chemosis, noted 1 hour after the test item installation and still noted at the end of the observation (D5);
- At the corneal level: a moderate opacity, registered 24 hours after the test item instillation, and still noted at the end of the observation (D5);
- At the iris level: a congestion was noted the 2ndday of the test;
It was noted an ulceration on the nictitating membrane from the 1stday of the test. This lesion persisted for 72 hours.
Taking into account the severity of the reactions, the test was stopped the 5thday of the test, in accordance with the principles of animal welfare.
The results obtained, under these experimental conditions, enable to conclude that the test item T2955 needs to be classified causing serious eyes damage (eye damage cat. 1; H318 Causes serious eye damage).
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