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EC number: 239-032-7 | CAS number: 14960-06-6
- 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

Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- Skin sensitisation study over a 6 weeks period involving three phases: (1) Induction, (2) Rest, (3) Challenge. The induction phase consisted of 9 consecutive applications of the test material for 24 hours and subsequent evaluations. The challenge phase was initiated after the rest period of 14 days in the sixth week of the study. Test substance was again applied for 24 hours and reactions graded 48 and 72 hours after application. A rechallenge was performed whereever there was evidence of possible sensitisation.
- GLP compliance:
- not specified
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
- Molecular formula:
- C18H35NO4.Na
- IUPAC Name:
- sodium 3-[(2-carboxyethyl)(dodecyl)amino]propanoate
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Sodium Lauriminodipropionate, MV#2764-178
- Substance type: foaming face wash formulation
- Physical state: test material is a foaming face wash containing 7.34% Deriphat 160C which is a 30 % solution of Sodium Laurimindiproprionate (MV#2764-178 - white pearlized lotion (tested as 2.0% (w/v) solution in distilled water)
- Analytical purity: contains 2.2 % of the test substance
- Composition of test material, percentage of components:
- Storage condition of test material: at room temperature
Method
- Type of population:
- general
- Ethical approval:
- confirmed and informed consent free of coercion received
- Subjects:
- - Number of subjects exposed: 110
- Sex: 12 male, 98 female
- Age: 18 to 25 (13 subject); 26 to 35 (17 subject); 36 to 45 (33 subjects); 46 to 55 (27 subjects); 56 to 65 (12 subjects); over 65 (8 subjects)
- Race: 17 caucasian, 92 hispanic, 1 other - Clinical history:
- - History of allergy or casuistics for study subject or populations: only subjects with no systemic or dermatological disorder were considered for the study
- Controls:
- none
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: occlusive
- Description of patch: non-porous, plastic film adhesive bandage with a 2 cm x 2 cm Webril pad affixed with hypoallergenic tape such as Scanpor or Micropore as needed
- Vehicle / solvent: water
- Concentrations: 2.0 % (w/v) solution for MV#2764-178
- Volume applied: 0.2 mL
- Testing/scoring schedule: 9 induction pads are consecutively applied each for 24 hours, reactions are scored 48 hours after application (if patch was applied on a friday, subjects removed the patch 24 hours later and reactions were scored the following monday (72 hours after application)); after scoring the next patch was applied; the induction phase is followed by a 2 week resting period, after which the challenge pads are applied to previously unexposed sites, the patches are again removed after 24 hours and reactions are scored 48 and 72 hours after application. In case of possible evidence for sensitization a rechallenge is conducted (occlusive and semiocclusive) 1 or two weeks after challenge, patches are again applied for 24 hours and scoring is done 48, 72 and 96 hours after application.
- Removal of test substance: removal of patch
EXAMINATIONS
Grading/Scoring system:
- no reaction
? doubtful response, barely perceptible erythema, only slightly different from surrounding skin
+ definite erythema, no edema
+* definite erythema, minimal or doubtful edema
++ definite erythema, definite edema
+++ definite erythema, definite edema & vesiculation
D or d damage to epidermis: d = drying/scaling; D = oozing, crusting and/or superficial erosions
Results and discussion
- Results of examinations:
- Only two subjects showed erythema and slight edema during the induction period, all other subjects were without reactions
Any other information on results incl. tables
Table1: Summary of Reaction Data
Induction | Challenge | ||||||||||
Grade | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 1 | 2 |
- | 106 | 105 | 103 | 106 | 105 | 99 | 101 | 92 | 94 | 102 | 103 |
? | 0 | 1 | 1 | 1 | 2 | 2 | 2 | 8 | 10 | 1 | 1 |
+ | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
+*p | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
++ | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
+++ | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
+*pD | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
NP | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
total readings | 106 | 106 | 104 | 107 | 107 | 101 | 104 | 101 | 104 | 103 | 104 |
# absent | 4 | 4 | 6 | 3 | 3 | 9 | 6 | 9 | 6 | 7 | 6 |
not applied | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
patch dislodged | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
total subjects | 110 | 110 | 110 | 110 | 110 | 110 | 110 | 110 | 110 | 110 | 110 |
Applicant's summary and conclusion
- Conclusions:
- Under the conditions employed in this study, there was no evidence of sensitization for the substance tested.
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