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Diss Factsheets
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EC number: 939-647-7 | CAS number: 1474044-68-2
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This OECD guideline and GLP-compliant study was performed on an analogue substance (for justification of read-across, please refer to the corresponding assessment report in Section 13).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Sodium N-(2-carboxyethyl)-N-dodecyl-β-alaninate
- EC Number:
- 239-032-7
- EC Name:
- Sodium N-(2-carboxyethyl)-N-dodecyl-β-alaninate
- Cas Number:
- 14960-06-6
- IUPAC Name:
- Sodium Lauriminodipropionate
- Test material form:
- other: liquid
- Details on test material:
- - Common name : Sodium lauriminodipropionate
- For more details, see below the Confidential details for test material
Constituent 1
- Specific details on test material used for the study:
- solid: particulate/powder migrated information: powder
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: male animals approx. 8 weeks, female animals approx. 12 weeks
- Weight at study initiation:203-236g
- Housing:Makrolon cage, type III
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period:Acclimatization period of at least 5 days before the beginning of the experimental phase
ENVIRONMENTAL CONDITIONS
- Temperature (°C):22°C +- 3°C
- Humidity (%):30 – 70%
- Air changes (per hr):10
- Photoperiod (hrs dark / hrs light):12 h / 12 h
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- olive oil
- Details on dermal exposure:
- TEST SITE
- Area of exposure:40 cm²
- % coverage: at least 10% of the body surface
- Type of wrap if used:semi-occlusive dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000mg/kg bw
- Constant volume or concentration used: yes
- For solids, paste formed: suspension in Olive Oil
VEHICLE (olive oil)
- Amount(s) applied (volume or weight with unit): 20 mL/kg bw (substance in vehicle)
- Concentration (if solution): 25 g/100 mL (concentration of substance in olive oil) - Duration of exposure:
- 24 hours
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Body weight determination: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation.
- Clinical observations: Recording of clinical signs several times on the day of administration, and at least once daily thereafter each workday for the individual animals.
- Scoring of skin findings: Individual readings 30 – 60 minutes after removal of the semi-occlusive dressing (day 1) and several times (see results) until the last day of observation
- Mortality: A check for any dead or moribund animals was made at least once each workday
- Pathology: Necropsy with gross-pathology examination on the last day of the observation period - Statistics:
- Common statistical procedures
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- discriminating dose
- Effect level:
- 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred
- Clinical signs:
- other: No systemic clinical signs were observed during clinical examination
- Gross pathology:
- No macroscopic abnormalities were observed
- Other findings:
- Skin effects at the application site comprised very slight erythema (grade 1) in all male animals and were observed on study day 1 and 2.
Skin effects at the application site comprised very slight erythema (grade 1) in four out of five female animals on study day 1 until day 2. One animal revealed very slight erythema on study day 1, well-defined erythema (grade 2) on study day 2 and again very slight erythema on day 3; additionally very slight edema (grade 1) was noted in this animal on day 2 and scaling on day 6. Scaling was also noted in two other animals on day 6; one of these animals also revealed incrustations on day 6.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EU GHS (CLP)
- Conclusions:
- Under the conditions of this study the median lethal dose (LD50) of the test item after dermal application was found to be higher than 5000 mg/kg bw in male and female rats.
- Executive summary:
In an acute dermal toxicity study (Limit Test), young adult Wistar rats (5 males and 5 females)were dermally exposed to a single dose of 5000 mg/kg bw of sodium lauriminodipropionate (as a suspension in olive oil) to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi-occlusive dressing for 24 hours according to the OECD 402 test guideline. The application area comprised at least 10% of the total body surface area. The animals were observed for 14 days.
The following test item-related local effects were recorded during the course of the study: very slight to well-defined erythema (grade 1 to 2), very slight edema (grade 1), incrustations and scaling.
The mean body weight of the male animals increased within the normal range throughout the study period. The mean body weight of the female animals did not significantly change during the first post-exposure observation week. This difference is commonly observed in the rat strain used, because in the required age range the female animals have already reached the phase of slow growth.
No signs of systemic toxicity or mortality were observed in the animals. No macroscopic pathologic abnormalities were noted in the animals upon necropsy.
Accordingly, the acute dermal median lethal dose (LD50) was determined to be higher than 5000 mg/kg bw.
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