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Diss Factsheets
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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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- 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 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class 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: White powder
- Lot/batch No.: 2625
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: Harlan U. K. Ltd., Bicester, Oxon, England
- Age at study initiation: 5-7 weeks
- Weight at study initiation: 90-118 g
- Fasting period before study: overnight
- Housing: Groups of 3 rats of the same sex in metal cages within the treatment group
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days prior to the start of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C):18.5-20
- Humidity (%):34-55%
- Photoperiod (hrs dark / hrs light): 12 h dark/ 12 h artificial light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 1% w/v aqueous methylcellulose
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20% w/v
DOSAGE PREPARATION (if unusual): on the day of dosing - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3 Female, Dose 2000 mg/kg
3 Male, Dose 2000 mg/kg - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Weight Record: Days 1, 8 and 15; Rats were checked daily at least for mortalities.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- Male: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0 - Clinical signs:
- Signs of toxicity related to dose levels: Clinical signs of reaction to treatment comprised of piloerection, salivation and hunched posture, seen in all animals on Day 1. In addition, abnormal gait and wet fur were observed in all females on Day 1. There were no other signs of reaction to treatment and recovery was complete in all males by Day 3 and in all females by Day 4.
- Body weight:
- All animals were considered to have achieved satisfactory bodyweight gains throughout the study.
- Gross pathology:
- No abnormalities were revealed at the macroscopic examination at study termination on Day 15.
Any other information on results incl. tables
Table 1: Mortality data:
Dose level (mg/Kg) |
Sex |
Nº of animals treated |
Deaths |
2000 |
Female |
3 |
0 |
2000 |
Male |
3 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- CLP Implementation.
- Conclusions:
- The acute toxicity study was realized according to OECD 423 guideline and EU method B.1 tris. The LD50 for the LAE is greater than 2000 mg/kg/bw.
- Executive summary:
According to OECD 423 guideline and EU method B.1 tris, this study was performed with the purpose of ranging LD50 for the test substance: Nα-Lauroyl-L-arginine ethyl ester monohydrochloride (LAE).
With this objective, a group of 6 fasted rats (three males and three females) received a single oral gavage dose of the test substance, formulated in 1%w/v aqueous methylcellulose and administered at a dose level of 2000 mg/kg bodyweight.
All animals were considered to have achieved satisfactory bodyweight gains throughout the study.
No abnormalities were revealed in any of the animals at the macroscopic examination at study termination on Day 15.
The acute lethal oral dose to rats of LAE was demonstrated in this study to be greater than 2000 mg/kg bodyweight.
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