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EC number: 941-634-6 | CAS number: 1228284-78-3
- 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
- Remarks:
- The in vivo eye irritation study was conducted solely to comply with a non-EU national registration requirement, and has been provided here in accordance with REACH, Article 22(1)e.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 February 2014 to 06 March 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- methoxy[1-(2,4,6-trichlorophenyl)propan-2-yl]amine
- EC Number:
- 941-634-6
- Cas Number:
- 1228284-78-3
- Molecular formula:
- C10H12Cl3NO
- IUPAC Name:
- methoxy[1-(2,4,6-trichlorophenyl)propan-2-yl]amine
- Test material form:
- other: liquid
- Details on test material:
- - Physical state: Brown liquid
- Expiration date of the lot/batch: Recertification date end September 2015
- Storage condition of test material: Room temperature (<30°C), protected from light and humidity
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 12-13 weeks
- Weight at study initiation: 3378-3688 g
- Housing: Individually housed in AAALAC approved open-wire metal cages.
- Diet: UNI diet for rabbits ad libitum
- Water: Tap water ad libitum
- Acclimation period: At least 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.1-20.4
- Humidity (%): 28-68
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 25 February 2014 To: 06 March 2014
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- Single application (treated eye rinsed with physiological saline solution 1 hour after application).
- Observation period (in vivo):
- 72 hours.
- Number of animals or in vitro replicates:
- 3 males.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes
- Time after start of exposure: 1 hour.
SCORING SYSTEM: Draize (1977) and OECD 405 (02 October 2012)
TOOL USED TO ASSESS SCORE: Fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 24-72 h
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- Conjunctival redness (score 2), chemosis (score 1) and discharge (score 3) were seen in all rabbits 1 hour after treatment. Conjunctival redness (score 1 or 2), chemosis (score 1) and discharge (score 1 or 2 or 3) were seen in all rabbits and corneal opacity (score 1, area 3) was noted in one rabbit 24 hours after treatment. Conjunctival redness (score 1 or 2) and discharge (score 1) were seen in all rabbits 48 hours after treatment. All symptoms had fully reversed in all animals by the 72 hours observations. Fluorescein staining was positive in one rabbit at 24 hours after instillation. Fluorescein staining was negative in two animals at 24 and in all animals at 48 and 72 hours after instillation. Control eyes were symptom-free during the study.
- Other effects:
- None.
Any other information on results incl. tables
Table 1: Eye irritation scores according to the Draize scheme
Time |
Cornea |
Iris |
Conjunctiva |
||||||||||
|
|
|
|
Redness |
Chemosis |
||||||||
|
Animal number |
719 |
718 |
889 |
719 |
718 |
889 |
719 |
718 |
889 |
719 |
718 |
889 |
after 1 hour |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
2 |
2 |
1 |
1 |
1 |
|
after 24 hours |
1 |
0 |
0 |
0 |
0 |
0 |
2 |
2 |
1 |
1 |
1 |
1 |
|
after 48 hours |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
1 |
1 |
0 |
0 |
0 |
|
after 72 hours |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
mean scores 24-72 hours |
0.3 |
0 |
0 |
0 |
0 |
0 |
1.3 |
1.0 |
0.7 |
0.3 |
0.3 |
0.3 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item was graded as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to the modified Kay and Calandra classification system.
- Executive summary:
The test item was administered as a single dose of 0.1 mL into the conjunctival sac of the left eye of each of 3 young adult male New Zealand White rabbits, the untreated right eye served as a control. Irritation was scored approximately 1, 24, 48 and 72 hours after administration. Observations with fluorescein staining were made approximately 24 hours before and 24, 48 and 72 hours after treatment. Rabbits were treated with analgesic and anaesthetic as per the regulatory guideline.
Conjunctival redness (score 2), chemosis (score 1) and discharge (score 3) were seen in all rabbits at 1 hour after treatment. Conjunctival redness (score 1 or 2), chemosis (score 1) and discharge (score 1 or 2 or 3) were seen in all rabbits and corneal opacity (score 1, area 3) was noted in one rabbit at 24 hours after treatment. Conjunctival redness (score 1 or 2) and discharge (score 1) were seen in all rabbits at 48 hours after treatment. All symptoms had fully reversed in all animals by the 72 hours observations. Fluorescein staining was positive in one rabbit at 24 hours after instillation. Fluorescein staining was negative in two animals at 24 and in all animals at 48 and 72 hours after instillation. The control eye of animals was symptom-free during the study. No mortality occurred during the study. The bodyweights of all rabbits were considered to be within the normal range of variability.
The test item was graded as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to the modified Kay and Calandra classification system.
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