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EC number: 688-011-2 | CAS number: 1243654-79-6
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From September 17, 2002, to October 1, 2002
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- not specified
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Pellicer
- IUPAC Name:
- Pellicer
- Details on test material:
- Chemical name: sodium salt as a condensation product of N-lauroyl-L-glutamic acid and L-lysine
Secondary name: LGM
Lot number: 2L-7
Description: clear colorless liquid
Purity: 30.0 wt%
Specific gravity: 1.06
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Sankyo Labo Service Corporation
- Age at study initiation: 5 weeks old
- Weight at study initiation: Mean: 106.8g for males and 98.0g for females
- Fasting period before study: 16 hours
- Housing: a group of five animals were housed on pulp bedding (Paper Clean, Japan SLC, Inc.,) in a flat-bottomed, polycarbonate cage.
- Diet: The animals had free access to pellet food (MF, Oriental Yeast Co., Ltd.) and water, except the period 16 hours before and 3 hours after administration during which only water was fed.
- Water: water was available throughout the study
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): temperature: 23°C ± 2°C
- Humidity (%): 50% ± 10%,
- Air changes (per hr): 17
- Photoperiod (hrs dark / hrs light): 12 hours light followed by 12 hours darkness
IN-LIFE DATES: From: Day 0 To: End of study
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: - not applicable
MAXIMUM DOSE VOLUME APPLIED: volume not stated in study report
DOSAGE PREPARATION (if unusual): sample provided for testing without dilution and used as supplied. - Doses:
- 2,000 mg/kg
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The observation for clinical signs was conducted on animal’s appearance, hair coat, position, posture, and behavior up to 6 hours after administration and on the following 14 days (everyday basis). During this period, food consumption and body weight were measured on the following days: the administration day, and 1, 2, 3, 4, 7, and 14 days after administration.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, food consumption - Statistics:
- No statistics used.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No rats died during the study
- Clinical signs:
- other: No particular symptoms of appearance, posture, and behavior were found in any rats during the observation period.
- Gross pathology:
- No significant changes were observed on the body surface, opening, cranial cavity, visceral organs in the pleuroperitoneal cavity, and lymph nodes
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of the study, it was concluded that the administration of the product to rats in a dose of 2000 mg/kg resulted in no toxic effects.
- Executive summary:
Single dose toxicity of sodium salt as a condensation product of N-lauroyl-L-glutamic acid and L-lysine in rats was investigated. The test was designed as a limit test, and a dose of 2000 mg/kg was administered to each male and female group of five Slc:Wistar rats.
The sample was provided for testing without dilution and administered in a single dose by oral gavage via a metal stomach tube. The viability and clinical signs of rats were observed for 14 days, during which their food consumption and body weight were measured. All rats were also examined by autopsy at the end of the observation period. Results showed that no rats died. In general, no significant changes were observed in any of the rats. Food consumption was normal throughout the observation period.
Body weight change showed steady increasing shifts, and the weight gain for 14 days was normal. In addition, no significant changes were observed in the autopsy report. Based on the above results, it was concluded that the administration of the product to rats in a dose of 2000 mg/kg resulted in no toxic effects.
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