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EC number: 606-883-4 | CAS number: 219921-94-5
- 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:
- 10 November 1998 - 12 January 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD 405) and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (S)-3-Methyl-1-(2-piperidine-1-phenyl)butylamine compound with N-Acetyl-L-glutamic acid
- EC Number:
- 606-883-4
- Cas Number:
- 219921-94-5
- Molecular formula:
- C16-H26-N2 x C7-H11-N-O5
- IUPAC Name:
- (S)-3-Methyl-1-(2-piperidine-1-phenyl)butylamine compound with N-Acetyl-L-glutamic acid
- Details on test material:
- - Name of test material (as cited in study report): AGEE 623 Glutaminate; L-Glutamic acid, N-acetyl, compd. with (S)-alpha-(2-methylpropyl)-2-(1-piperidinyl)-benzenemethanamine
- Physical state: White solid
- Analytical purity: 100% (4% of (R)-(-)-enantiomer) measured peak HPLC
- Lot/batch No.: T29725
- Expiration date of the lot/batch: 31 December 1999
- Stability under test conditions: pure: at least 20 months; in solvent: stable for at least 2 hours in water and organic solvents
- Storage condition of test material: room temperature, light protected
- Other: Routine hygienic procedures will be sufficient to assure personnel health and safety
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Germany GmbH, 88353 Kißlegg
- Weight at study initiation: 3.2 kg, 3.7 kg, 5.0 kg
- Housing: individually housed in ABS - plastic rabbit cages
- Diet (e.g. ad libitum): ad libitum, Altromin 2123 maintenance diet rabbit
- Water (e.g. ad libitum): ad libitrum, tap water
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +- 3°C
- Humidity (%): 55 +- 10 %
- Air changes (per hr): at least x 10/ hour
- Photoperiod (hrs dark / hrs light): 12 : 12 hours, light/dark
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- A dose of 0.1 g was applied to the test site.
- Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after start of the treatment.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM:
The eye irritation scored were evaulated according to the scoring system by Draize (1959) and OECD 405 ( 24 April 2002).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 4
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 3
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- chemosis
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 4
- Max. score:
- 4
Any other information on results incl. tables
One hour after application all criteria of evaluation were rated at the highest possible score. The iris was not discernible through the opacity of the cornea. The alternations lasted up to the 72 h reading, when the animals were euthanised due to animal welfare. Severe corneal lesions were found upon fluorescein examination at the 72 h reading. The test item produced corrosion the eyes of all test animals. the total mean cumulative scores of the 24, 48 and 72 hour readings did exceed the limit values according to directive 93/21 EEC.
Individual and Total Mean Cumul.Score - 24, 48, 72 hour reading
Animal |
Sex |
Cornea |
Iris |
Conjunctivae |
Cumul. Score |
Primary Irrit. Score |
|
A |
B |
||||||
1 |
f |
4.00 |
* |
3.00 |
4.00 |
11.00* |
|
2 |
f |
4.00 |
* |
3.00 |
4.00 |
11.00* |
|
3 |
f |
4.00 |
* |
3.00 |
4.00 |
11.00* |
11.00* |
Total Mean: |
|
4.00 |
* |
3.00 |
4.00 |
|
|
*Iris not discernible through the opacity of the cornea
A=Redness; B=Chemosis
No other toxic effects were observed.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item caused severe erythema and swelling of the conjunctivae, opacity of the comea, the iris not being discernible through the opacity in all
animals at the 1 h reading, lasting up to 72 h after application.
Severe comeallesions were found upon fluorescein examination at the 72 h reading.
The total mean cumulative scores of the 24, 48 and 72 hour readings did exceed the limit values according to Directive 93/21 EEC.
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