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EC number: 271-685-3 | CAS number: 68604-33-1 This substance is identified by SDA Substance Name: C14-C18 and C16-C18 unsaturated alkyl carboxylic acid ammonium salt and SDA Reporting Number: 04-006-01.
- 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
Direct observations: clinical cases, poisoning incidents and other
Administrative data
- Endpoint:
- direct observations: clinical cases, poisoning incidents and other
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Publication on non-guideline study, classification on the basis of the available results is not possible.
Data source
Reference
- Reference Type:
- publication
- Title:
- Cutaneous response to irritants
- Author:
- Santucci, C., Cannistraci, C., Lesnoni, I., Ferraro, C., Rocco, M., Dell'Anna, L., Giannarelli, D., Cristaudo, A.
- Year:
- 2 003
- Bibliographic source:
- Contact Dermatitis 48: 69-73
Materials and methods
- Study type:
- study with volunteers
- Endpoint addressed:
- skin irritation / corrosion
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Several substances (including the analogue substance) were tested for their skin irritation potential. They were applied to healthy skin and to skin exhibiting pre-existing dermatitis for the purpose of comparison.
- GLP compliance:
- no
Test material
- Reference substance name:
- Potassium oleate
- EC Number:
- 205-590-5
- EC Name:
- Potassium oleate
- Cas Number:
- 143-18-0
- Molecular formula:
- C18H34O2.K
- IUPAC Name:
- potassium octadec-9-enoate
- Test material form:
- other: liquid
Constituent 1
Method
- Type of population:
- general
- Subjects:
- - Number of subjects exposed: 520
- Sex: male and female
- Age: 8-73 years
- Known diseases:
group 1: 40 healthy subjects (10 men and 30 women)
group 2: 19 mean and 21 women with atopic dermatitis
group 3: 26 men and 31 women with active psoriasis
group 4: 31 men and 93 women with eczema, giving positive patch test responses
group 5: 53 men and 87 women with eczema with no patch test responses
group 6: 21 men and 58 women with active urticaria
group 7: 14 men and 26 women with generalized pruritus - Ethical approval:
- not applicable
- Route of exposure:
- dermal
- Reason of exposure:
- intentional
- Exposure assessment:
- measured
- Details on exposure:
- 15 µL of the substance (concentration 5 %) were applied to the skin for a duration of 2 days. Two patches were therefore applied to the upper back. Additionally patches were applied to patients with urticaria, these were removed after 30 min.
- Examinations:
- - Other: the skin was examined and scored according to the following system:
0: no visible reaction
1: erythema
2: erythema with oedema
3: erythema with oedema and papules
4: erythema with vesicles or bullae
Readings were performed one hour after patch removal (after 2 days of exposure) and immediately after removal of the patches (after 30 min of exposure). - Medical treatment:
- none
Results and discussion
- Clinical signs:
- After 2 days of exposure with the analogue substance positive responses were found in 0.2 % of the test persons. Exposure with the positive controls led to positive reactions in 36 % (BAK), 38 % (SLS) and 1.3 % (DMSO) persons, respectively. Positive responses to both BAK and SLS were seen in 22 %.
- Effectivity of medical treatment:
- not applicable
- Outcome of incidence:
- not applicable
Any other information on results incl. tables
Table 1: positive responses to the analogue substance and positive controls
|
healthy |
atopic dermatitis |
psoriasis |
eczema with positive patch test |
eczema with negative patch test |
urticaria |
pruritus |
No of subjects |
40 |
40 |
57 |
124 |
140 |
79 |
40 |
analogue substance 5% |
neg |
neg |
neg |
1 |
neg |
1 |
neg |
BAK 1 % |
17 |
12 |
22 |
50 |
53 |
26 |
11 |
SLS 1 % |
16 |
13 |
18 |
54 |
56 |
26 |
17 |
DMSO 10 % |
1 |
neg |
2 |
6 |
2 |
1 |
neg |
Applicant's summary and conclusion
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.