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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: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From November 17, 2005 to March 17, 2006
- 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:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.2 (Acute Toxicity (Inhalation))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1300 (Acute inhalation toxicity)
- 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
- Details on test material:
- - Name of test material: LAE in ethanol
- Physical state: Spray can
- Lot/batch No.: LI-531
- Storage condition of test material: Room temperature / darkness
Constituent 1
- Specific details on test material used for the study:
- Substance: L.A.E. in ethanol
Batch number: LI-631 as of Oct. 19, 2005, content 0.634% of LAE
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Adult SPF bred Wistar Unilever rats, strain Hsd Cpb:WU from the experimental breeder Harlan-Winkelmann GmbH, Borchen (Germany) and Harlan Nederland (The Netherlands)
- Age at study initiation: 2 months old
- Weight at study initiation: Variation of individual weight did not exceed ±10% of the mean for each sex. Females: 173-187 g; males 176-201 g
- Housing: Singly in conventional Makrolon® Type IIIH cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days prior to start
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2ºC
- Humidity (%): 40-70%
- Air changes (per hr): 10 air changes per hour approximately
- Photoperiod (hrs dark / hrs light): 12 hours artificial light each 24 hours
IN-LIFE DATES: No mortalities
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Exposure tubes applying a directed-flow nose-only exposure principle.
- Exposure chamber volume: 50 L
- Source and rate of air: 20 l/min
- Method of conditioning air: Calibrated flowmeter/Soap bubble meter
- System of generating particulates/aerosols: Magnetic piston equipped with two electronic clocks
- Method of particle size determination: TSI-Laser velocimeter APS
- Treatment of exhaust air: Exhaust air was purified via cotton-wool/HEPA filters
- Temperature, humidity, pressure in air chamber: 21.9-23.2 ºC, humidity values were lower than recommended due to the use of conditioned, dry air for dispersion of the test substance.
TEST ATMOSPHERE
- Brief description of analytical method used: Gas chromatographic method (for propellants); HPLC (for the active ingredient)
- Samples taken from breathing zone: yes, in the vicinity of the breathing zone of the animals
VEHICLE
- Composition of vehicle (if applicable): Undiluted
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: Adequate to reach all potential target structures of the respiratory tract
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 4.6 um / 1.92 - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- Target concentration: 25000 mg/m3 (nominal 42000mg/m3).
- No. of animals per sex per dose:
- Group 1: Target concentration 0 mg/m3
5 male per dose
5 female per dose
Group 2: Target concentration: 25.000 mg/m3
5 male per dose
5 female per dose - Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Weighing record: before exposure, day 3, 7 and 14; Observations: Several times on the day of exposure, at least once daily thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight and reflexes. - Statistics:
- Statistical Evaluation of data:
Necropsy findings: In case of findings: Fisher test
Body weights: One-way ANOVA (vida infra)
Physiological data: Data of rectal temperature measurements are statistically evaluated using the ANOVA procedure (vida infra)
LC50: Rosello et al.; Schaper et al.
Analysis of variance: ANOVA (p= 0.05)
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 28 150 mg/m³ air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: LAE in ethanol
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5 883 mg/m³ air (analytical)
- Based on:
- act. ingr.
- Exp. duration:
- 4 h
- Remarks on result:
- other: LAE
- Mortality:
- Mortality was not observed.
- Clinical signs:
- other: Group 1: All rats tolerated the exposure without specific signs. Group 2/Males: Bradypnea, labored breathing patterns, irregular breathing patterns, high-legged gait, piloerection. Group 2/Females: Labored breathing patterns, irregular breathing patterns,
- Body weight:
- Comparisons did not reveal changes in body weights considered to be of toxicological significance.
- Gross pathology:
- Animals sacrified at the end of the observation period: The macroscopic findings were indistinguishable amongst the groups.
Any other information on results incl. tables
Results obtained after exposure of rats for 4 hours:
Group/sex |
Target concentration (mg/m3) |
Toxicological result(*) |
Onset and duration signs |
Onset mortality |
1 / m |
0 |
0/0/5 |
- |
- |
2 / m |
25000 |
0/4/5 |
0 d - 3 d |
- |
1 / f |
0 |
0/0/5 |
- |
- |
2 / f |
25000 |
0/1/5 |
0 d - 4 d |
- |
(*) Number of dead animals/Number of animals with signs after cessation of exposure/Number of animals exposed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- CLP Implementation.
- Conclusions:
- Combined experimental evidence suggest that the test substance has a mild respiratory tract irritation potential if exposure is sufficiently high. Thus, the LC50 is greater than 28150 mg/m3 (LAE in ethanol). The LC50 for LAE is greater than 5883 mg/m3 (analytical concentration).
- Executive summary:
The test conditions applied fulfilled recommendations of current test guidelines according to the OECD Guideline Nº 403 and EU method B.2, with regard to attainment of steady-state concentration, respirability of particles and the limit concentration tested. The aerosolized test substance proved to have virtually no acute inhalation toxicity to rats and mortality did not occurred even at levels of exposure exceeding significantly the limit concentration called for by the current testing guidelines applied. Combined experimental evidence, however, would suggest that the test substance has a mild respiratory tract irritation potential, if exposure to the aerosol is sufficiently high. Thus, for the test substance the LC50 is greater than 28150 mg/m3 (LAE in ethanol). The LC50 for LAE is greater than 5883 mg/m3 (analytical concentration).
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