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EC number: 434-630-6 | CAS number: 60372-77-2
- 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:
- From November 11, 1996 to February 18, 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Guideline study with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
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
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 434-630-6
- EC Name:
- -
- Cas Number:
- 60372-77-2
- Molecular formula:
- Hill formula: C20H41N4O3Cl
- IUPAC Name:
- ethyl N2-dodecanoyl-l-argininate hydrochloride
- Test material form:
- solid: particulate/powder
- Details on test material:
- Nature of substance: powder
- Name of test material: Nα-Lauroyl-L-arginine ethyl ester monohydrochloride
- Analytical purity: 90%
- Lot/batch No.: 5159
- Storage condition of test material: Room temperature, darkness
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: B&K Universal GJ, S. L.
- Age at study initiation: 9-10 weeks
- Weight at study initiation: 2.4 Kg
- Housing: Individually in steel cages (48x59x37 cm)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22 ºC
- Humidity (%): 45-80 %
- Photoperiod (hrs dark / hrs light): 12 hours each 24 hours.
IN-LIFE DATES: From: November 11, 1996; To: December 2, 1996
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.1 mL (84 mg)
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM:
Cornea Opacity: Degree of density (area most dense taken for reading)
- No ulceration or opacity: 0
- Scattered or diffuse areas of opacity (other than slight dulling of normal lustre),
details of iris clearly visible: 1
- Easily discernible translucent area, details of iris slightly obscured: 2
- Nacreous area, no details of iris visible, size of pupil barely discernible: 3
- Opaque cornea, iris not discernible through the opacity: 4
Iris:
- Normal: 0
- Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia,
or injection, any of these or combination of any thereof, iris still reacting to light
(sluggish reaction is positive): 1
- No reaction to light, haemorrhage, gross destruction (any or all of these): 2
Conjunctivae: Redness (refers to palpebral and bulbar conjunctivae)
- Blood vessels normal: 0
- Some blood vessels definitely hyperaemic (injected): 1
- Diffuse, crimson colour, individual vessels not easily discernible: 2
- Diffuse beefy red: 3
Edema: Lids and/or nictitating membranes
- No swelling: 0
- Slight swelling (includes nictitating membranes): 1
- Obvious swelling with partial eversion of lids: 2
- Swelling with lids about half-closed: 3
- Swelling with lids more than half-closed: 4
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 4
- Reversibility:
- not fully reversible within: 21 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 4
- Reversibility:
- not fully reversible within: 21 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 4
- Reversibility:
- not fully reversible within: 21 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 7 d
- Score:
- 3
- Remarks on result:
- other: At 24h: not possible (white corneal opacity and suppuration)
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Reversibility:
- not fully reversible within: 21 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Reversibility:
- not fully reversible within: 21 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 4
- Reversibility:
- not fully reversible within: 21 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 4
- Reversibility:
- not fully reversible within: 21 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 4
- Reversibility:
- not fully reversible within: 21 d
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- not determinable
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- not determinable
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- not determinable
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes not fully reversible within 21 days
- Other effects:
- It was not possible to assess the effects of the test substance on the iris due to the opacity of the cornea.
Any other information on results incl. tables
Table 1: Acute eye irritation: Results.
Animal Nº. |
REGION OF EYE |
1 h |
24 h |
48 h |
72 h |
7d |
14 d |
21 d |
|
1 |
Cornea |
Density |
3 |
4 |
4 |
4 |
4 |
3 |
4 |
Iris |
0 |
- |
- |
- |
- |
- |
- |
||
Conjunctiva |
Hyperaemia |
2 |
* |
* |
* |
3 |
2 |
2 |
|
Edema |
4 |
4 |
4 |
4 |
4 |
3 |
3 |
||
2 |
Cornea |
Density |
3 |
4 |
4 |
4 |
4 |
4 |
4 |
Iris |
0 |
- |
- |
- |
- |
- |
- |
||
Conjunctiva |
Hyperaemia |
2 |
* |
3 |
3 |
3 |
2 |
2 |
|
Edema |
4 |
4 |
4 |
4 |
4 |
4 |
3 |
||
3 |
Cornea |
Density |
3 |
4 |
4 |
4 |
4 |
4 |
4 |
Iris |
0 |
- |
- |
- |
- |
- |
- |
||
Conjunctiva |
Hyperaemia |
2 |
* |
* |
3 |
3 |
2 |
2 |
|
Edema |
4 |
4 |
4 |
3 |
3 |
2 |
2 |
-: Not possible (corneal opacity)
*: Not possible (white corneal opacity and suppuration)
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Remarks:
- CLP Implementation.
- Conclusions:
- The scope of this experimental study was to evaluate the degree of eye irritation or corrosion caused by Nα-Lauroyl-L-arginine ethyl ester monohydrochloride (LAE) after a single application to the surface of 3 rabbit's eye. Observations to obtain current results were recorded until 21 days after administration. Results showed that the substance is causing severe ocular damage and is classified as eye irritating.
- Executive summary:
The aim of this Study was to determine the degree of eye irritation or corrosion caused by Nα-Lauroyl-L-arginine ethyl ester monohydrochloride (LAE) after a single application to the surface of the rabbit's eye.
A total of 3 albino rabbits were tested by a single application of 0.1 ml (90% purity of the test substance) to one of the eye, the untreated eye serves as the control. The degree of eye irritation/corrosion was evaluated by scoring lesions of conjunctiva, cornea and iris at specific intervals.
The animal behavior was observed immediately after instillation of the product and then were returned to their cages and checked at regular intervals.The degree of ocular irritation was evaluated in each rabbit at 1, 24, 48 and 72 hours after treatment, following the criteria set out below. Additional observations were made at 7, 14 and 21 days after administration to assess the reversibility or irreversibility of the same.After assessment and evaluation of the alterations according to the OECD GUIDELINE FOR TESTING OF CHEMICALS, protocol no. 405, of 24thFebruary 1987 and the EEC Directive of the 31stMy 1992 (92/69/EEC) Annex, PartB, Method B.5, it is considered to cause irreversible effects on the eye (Category I) according to CLP Regulation.
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