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Diss Factsheets
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EC number: 947-850-7 | CAS number: -
- 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:
- weight of evidence
- Study period:
- 16 Jun 2013 to 15 Jan 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- adopted 24 February, 1987
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Groupe Interministeriel des Produits Chimique, Fait a Ivry, France, 13 Sep 2013
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- N-lauroylsarcosine
- EC Number:
- 202-608-3
- EC Name:
- N-lauroylsarcosine
- Cas Number:
- 97-78-9
- Molecular formula:
- C15H29NO3
- IUPAC Name:
- N-dodecanoyl-N-methylglycine
- Test material form:
- other: waxy solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Janvier, Le Genest St Isle, France
- Age at study initiation: 7 weeks (males), 8 weeks (females)
- Weight at study initiation: 232-252 g (males), 207-224 g (females)
- Housing: Individually during treatment, then in groups of five from day 1 on in solid- bottomed clear polycarbonate cages with a stainless steel mesh lid. Dust free sawdust was used as bedding, changed at least twice per week
- Diet: SAFE - A04, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): 13
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 30 Jul 2013 To: 13 Aug 2013
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: 10%
- Type of wrap if used: porous gauze dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated areas were rinsed with distilled water
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.14 mL/kg bw (corresponding to 2 g/kg, according to the calculated density) - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: examination of behavioural or toxic effects/mortality daily, weighing was performed on D0 and then on D2, D7 and D14.
- Necropsy of survivors performed: yes, on D14
- Other examinations performed: clinical signs, body weight, organs likely to be modified in cases of acute toxicity. Organs presenting macroscopic anomalies could optionally be removed and preserved for subsequent microscopic examinations.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occured during the study period.
- Clinical signs:
- other: No systemic clinical signs of toxicity related to the administration of the test item were observed up to the end of the 14-day observation period.
- Gross pathology:
- Macroscopic examination at the end of the study revealed no treatment-related changes.
- Other findings:
- - Other observations: Cutaneous reactions (erythema, dryness and scab) were noted from Day 1 in all animals and remained until Day 14 (scab) in all females and one in one male.
Any other information on results incl. tables
Conclusion:
The dermal LD50 of the test item in the rat was higher than 2000 mg/kg/bw.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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