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Diss Factsheets
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EC number: 258-007-1 | CAS number: 52558-73-3
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 9 Dec 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- adopted in March 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Version / remarks:
- adopted in April 2000
- Deviations:
- no
- GLP compliance:
- 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:
- other: human
- Strain:
- other: EpiDermTM Skin Corrosivity Test; reconstructed three-dimensional human epidermis (EPI-200)
Test system
- Type of coverage:
- other: in vitro system
- Preparation of test site:
- other: intact reconstructed human epidermis
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: concurrent control tissues treated with distilled water served as negative controls, positive controls were exposed to potassium hydroxide.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL
NEGATIVE CONTROL SUBSTANCE
- Amount(s) applied (volume or weight with unit): 50 µL distilled water
POSITIVE CONTROL SUBSTANCE
- Amount(s) applied (volume or weight with unit): 50 µL potassium hydroxide, 8N - Duration of treatment / exposure:
- 3 min and 1 h
- Observation period:
- Not applicable. Post-treatment incubation period 3 h.
- Number of animals:
- Not applicable. The test was performed in duplicate tissues for each treatment and control group.
- Details on study design:
- TEST SITE
- Area of exposure: 0.6 cm²
REMOVAL OF TEST SUBSTANCE
- Washing: Example: the test item was washed with saline solution from the skin surface.
- Time after start of exposure: 3 and 60 min
- Post-treatment incubation period: 3 h
CELL VIABILITY MEASUREMENTS:
For determining alterations in cell viability, MTT reduction assays were performed 3 h after the incubation period. Therefore, tissues were incubated in MTT solution for 3 h at 37 ± 1 °C and 5% CO2. After elimination of the MTT solution, tissues were washed 3 times in PBS.. After removing the tissue obtained dye solution was homogenized and transferred in triplicate aliquots of 200 µL to 96-well plate. The optical density was measured at 570 nm wave length in a plate spectrophotometer.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min
- Value:
- 27
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 min
- Value:
- 6
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- Based on the available data the substance has to be considered as corrosive under the conditions of the test.
Any other information on results incl. tables
Table 1: MTT assay after 3 min exposure
|
Negative control |
Positive control |
Test item |
|||
Tissue sample |
1 |
2 |
1 |
2 |
1 |
2 |
OD570 |
2.007 1.993 2.010 |
2.067 2.032 2.074 |
0.545 0.527 0.533 |
0.438 0.431 0.436 |
0.485 0.472 0.475 |
0.650 0.626 0.629 |
OD570(mean) |
2.003 |
2.058 |
0.535 |
0.435 |
0.477 |
0.635 |
OD570(mean values of replicates) |
2.031 |
0.485 |
0.556 |
|||
Viability (%) |
100 |
24 |
27 |
Table 2: MTT assay after 60 min exposure
|
Negative control |
Positive control |
Test item |
|||
Tissue sample |
1 |
2 |
1 |
2 |
1 |
2 |
OD570 |
1.841 1.848 1.853 |
1.687 1.640 1.658 |
0.168 0.163 0.191 |
0.251 0.250 0.252 |
0.091 0.093 0.086 |
0.119 0.117 0.116 |
OD570(mean) |
1.847 |
1.662 |
0.174 |
0.251 |
0.090 |
0.117 |
OD570(mean values of replicates) |
1.755 |
0.213 |
0.104 |
|||
Viability (%) |
100 |
12 |
6 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Skin corr. 1, H314. Classification according to Regulation (EC) No. 1272/2008 (CLP/EU GHS).
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