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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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From March 16, 2000 to July 27, 2000
- 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:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- 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:
- - Name of test material: Nα-Lauroyl-L-arginine ethyl ester monohydrochloride
- Physical state: Powder
- Lot/batch No.: 2625
- Expiration date of the lot/batch: Not advised
- Storage condition of test material: 4ºC in the dark
Constituent 1
- Specific details on test material used for the study:
- Substance: L.A.E.
Batch number: 2625
Expiry date: March 14, 2000.
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hsd: Sprague-Dawley obtained from Harlan U.K. Ltd., Bicester, Oxon, England
- Age at study initiation: 8-12 weeks prior to dosing
- Weight at study initiation: 206-256 g
- Housing: Individually in metal cages fitted with grid floors to ensure rapid removal of waste material to undertrays.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days prior to the start of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5-20ºC
- Humidity (%): 42-56%
- Photoperiod (hrs dark / hrs light): 12 h artificial light each 24 hour period
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: 1% w/v aqueous methylcellulose
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 50 mmx50 mm
- % coverage: 10%
- Type of wrap if used: Porous gauze with a non-irritating dressing, further covered by a waterproof dressing encircled firmly around the trunk of the animal.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): With warm water (30-40ºC)
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 3.0 ml/kg bw
- Concentration (if solution): 667 mg/ml in 1% w/v methylcellulose - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations twice daily; The bodyweight of each rat was recorded on Days 1, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic appearance
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- Signs of toxicity related to dose levels:
There was no evidence of a systemic response in any animal throughout the study.
All animals were considered to have achieved satisfactory
bodyweight gains throughout the study. - Body weight:
- All animals were considered to have achieved satisfactory bodyweight gains throughout the study.
- Gross pathology:
- Effects on organs:
No macroscopic abnormalities were observed for animals killed at study termination on Day 15, with the exception of scabbing on the dose sites of three rats, plus thickening of the tissues on one. - Other findings:
- Signs of toxicity (local):
There were no deaths and no clinical signs of reaction to treatment observed in any animal throughout the study.
Well-defined irritation (erythema and oedema up to Grade 2) was notable in all rats following removal of the dressings on Day 2 and persistent at this level throughout the following days before resolving in all but two instances by Day 9. In two rats a dermal response persisted through to Day 12 or 14 before resolving. Associated with the dermal irritation were reactions characterised by blanching of the skin, localised spots and/or scabbing and/or thickening of the skin and desquamation. These responses had resolved in all but three instances by Day 15.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- CLP Implementation.
- Conclusions:
- Nα-Lauroyl-L-arginine ethyl ester monohydrochloride (L.A.E) was demonstrated to be greater than 2000 mg/kg bw.
- Executive summary:
According to the OECD Guideline Nº 402 and EU method B.3, a group of 10 rats, 5 males and 5 females, received a single topical application of the test substance formulated in 1% w/v aqueous methylcellulose and administered at a dosage of 2000 mg/kg bodyweight.
There were no clinical signs of reaction to Nα-Lauroyl-L-arginine ethyl ester monohydrochloride (L.A.E) treatment observed in any animal throughout the study.
Well-defined irritation (erythema and oedema up to Grade 2) was notable in all rats following removal of the dressings on Day 2 and persistent at this level throughout the following days before resolving in all but two instances by Day 9. In two rats a dermal response persisted through to Day 12 or 14 before resolving. Associated with the dermal irritation were reactions characterised by blanching of the skin, localised spots and/or scabbing and/or thickening of the skin and desquamation. These responses had resolved in all but three instances by Day 15.
No macroscopies abnormalities were observed for animals killed at study termination on Day 15, with the exception of scabbing on the dose sites of three rats, plus thickened tissues on one.
The acute lethal dermal dose to rats of L.A.E. was demonstrated to be greater than 2000 mg/kg bodyweight.
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