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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
Endpoint summary
Administrative data
Description of key information
Two GLP in-vitro studies for Skin irritation/corrosion were conducted with the substance according to OECD 431 and 439.
In the in vitro EPISKIN (SM) model test according to OECD 431, the results indicate that the test item is not corrosive. In the in vitro EPISKIN (SM) model test according to OECD 439 the mean cell viability was 42% compared to the negative control and therefore irritant.
One GLP in-vitro Eye irritation test in Isolated Chicken Eyes was conducted according to OECD 438 and one in-vivo acute eye irritation study in rabbits accordimg to OECD 405 was conducted with the test item. Mild irritation were noted in all animals in the in vivo study but all symptoms had fully reversed in all animals by the 72 -hour observation.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: UN (2009), United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS), third revised edition, UN New York and Geneva.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EpiSkin™ SOP, Version 1.8 (February 2009), ECVAM Skin Irritation Validation Study: Validation of the EpiSkin™ test method 15 min - 42 hours for the prediction of acute skin irritation of chemicals.
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Species:
- other: Reconstructed human epidermis model EPISKIN (SM)
- Details on test animals or test system and environmental conditions:
- HUMAN SKIN: EPISKIN (SM) (Manufacturer: SkinEthic, France, Batch No.:13-EKIN-045, Expiry Date: 23 December 2013) is a three-dimensional human epidermis model.
EXPERIMENTAL DATES: From: 18 December 2013 To: 20 December 2013 - Duration of treatment / exposure:
- 15 mins
- Irritation / corrosion parameter:
- other: other: optical density
- Value:
- 0.311
- Remarks on result:
- other:
- Remarks:
- Basis: mean. (migrated information)
- Irritation / corrosion parameter:
- other: other: viability
- Value:
- 42
- Remarks on result:
- other:
- Remarks:
- Basis: mean. (migrated information)
- Irritant / corrosive response data:
- The optical density for the test item treated skin was 0.311 and had a viability of 42%.
The optical densities for the negative and positive controls were 0.740 and 0.088, respectively and had viabilities of 100% and 12% respectively.
The test item is, therefore, considered to be irritant to skin, as the mean relative viability after 15 minutes exposure and 42 hours post incubation, is less or equal to 50% of the negative control. The positive control was irritant. - Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: UN GHS
- Conclusions:
- In an in vitro EPISKIN (SM) model test, the results indicate that the test item is Irritant [UN GHS: Category 2].
- Executive summary:
The reconstructed human epidermis model EPISKIN (SM) is designed to predict and classify the skin irritant potential of chemicals, by measuring its cytotoxic effect, as reflected in the MTT assay, on the EPISKIN reconstituted human epidermis. This method is approved by international regulatory agencies as a replacement for the identification of irritants / corrosives in the in vivo rabbit skin assay (OECD 404).
Disks of EPISKIN (three units / chemical) were treated with the test item and incubated for 15 minutes at room temperature. Exposure of test material was terminated by rinsing with phosphate buffered saline (PBS). Epidermis units were then incubated at 37°C for 42 hours in an incubator with 5% CO2. The viability of the epidermis on each disk was assessed by incubating the tissues for 3 hours with MTT solution at 37°C in 5% CO2 protected from light. The formazan extract in acidified isopropanol was then spectrophotometrically evaluated for optical density (OD) and quantified. SDS 5% and PBS treated epidermis were used as positive and negative controls, respectively. An additional disk was used to provide an estimate of colour contribution from the test item. For each treated tissue viability was expressed as a % relative to negative control. If the mean relative viability after 15 minutes exposure and 42 hours post incubation is less or equal (≤) to 50% of the negative control, the test substance is considered to be irritant to skin.
Following exposure with the test item, the mean cell viability was 42% compared to the negative control and, therefore, irritant. All validity criteria were within acceptable limits and therefore the study can be considered as valid.
In the in vitro EPISKIN (SM) model test, the results indicate that the test item is Irritant [UN GHS: Category 2].
Reference
Table 1: Optical density and calculated % viability of cells
Substance |
Optical density |
Viability (%) |
|
Negative control PBS |
1 |
0.770 |
104 |
2 |
0.728 |
98 |
|
3 |
0.721 |
97 |
|
mean |
0.740 |
100 |
|
Positive control SDS 5% |
1 |
0.100 |
14 |
2 |
0.095 |
13 |
|
3 |
0.070 |
9.5 |
|
mean |
0.088 |
12 |
|
Test item |
1 |
0.259 |
35 |
2 |
0.415 |
56 |
|
3 |
0.259 |
35 |
|
mean |
0.311 |
42 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- 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.
- 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)
- 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 - 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 - 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.
- 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.
Reference
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 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the above stated assessment of the skin irritation/corrosion potential, N-methoxy-1 -(2,4,6 -trichlorophenyl)propan-2 -amine does have to be classified for Skin Irritation Category 2 (H315 Causes skin irritation) according to CLP (Regulation (EC) No 1272/2008 Of the European parliament and of the Council.
N-methoxy-1 -(2,4,6 -trichlorophenyl)propan-2 -amine does not have to be classified for Eye irritation according to CLP (Regulation (EC) No 1272/2008 Of the European parliament and of the Council.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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