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EC number: 270-299-2 | CAS number: 68424-38-4 This substance is identified by SDA Substance Name: C16-C18 alkyl carboxylic acid sodium salt and SDA Reporting Number: 19-006-04.
- 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
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline Study and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
- Type of study / information:
- Identity of test material same as for substance defined in section 1 (if not read-across)
- Endpoint addressed:
- skin irritation / corrosion
Test guideline
- Qualifier:
- according to guideline
- GLP compliance:
- yes
Test material
- Reference substance name:
- Edenor C16 92/94
- IUPAC Name:
- Edenor C16 92/94
- Reference substance name:
- Edenor Ti dest. (fatty acid C 16 - 18 + 18')
- IUPAC Name:
- Edenor Ti dest. (fatty acid C 16 - 18 + 18')
- Details on test material:
- The following substances were investigated for skin irritatlon:
1 = Lorol, technisch (Fettalkohol C12 - 18) - FA010
2 = Lorol RG, neutral (Fettalkohol dest. Rückstand) - FA015
3 = Lorol RG, alkalisch (Fettalkohol dest. Rtickstand) - FA015
4 = Edenor C 12 98/100 (Fettsäure C 12) - FS004
5 = Edenor C 16 92/94 (Fettsäure C 16) - FS008
6 = Edenor Ti dest. (Fettsäure C 16 - 18 + 18') - FSOlO
7 = Polyresidal N (Ruckstand gesättige Fettsäuren) - FS016
8 = Polyresidal F (Rtickstand ungesättigte Fettsäuren) - FSOl7
9 = Edenor ME C 6 - 10 (Fettsäuremethylester C 8) - FSMEOOl
10 = Edenor ME Ti 05 F (Fettsauremethylester C 14 - 18 + 16' - 18') - FSMEOO5
11 = Edenor ME Palm (Fettsäuremethylester C: Palm) - FSME013
12 = Edenor ME Rückst. I1 (Fettsäuremethylester dest. Rückstand) - BSME 016
13 = Ke 491 (FS8 - 10 + TMPr + NPG) - ESTOOl
14 = Eden01 B 35 (FE18EPO) + 2/6 Guer) - ESTOO2
15 = Triacetin - GLYOOl
16 = Magnesiumsilikat - SNS004
Constituent 1
Constituent 2
Method
- Ethical approval:
- confirmed and informed consent free of coercion received
- Details on study design:
- The test method was the closed epicutaneous application of the method described in Frosch (Finn Chamber assay, modified Duhring-chamber test was selected). 70 μl of the test substances were applied once for a period of 24 hours on the skin of the back, using a Large Finn Chamber on Scanpor . After removal of the patch the skin were observed after 1, 6, 24, 48, 72 and 144 hours.
The following parameters were evaluated:
- erythema
- edema
- dandruff
- formation of fissures
At the examination 20 voluntary healthy female and male subjects with an age of 21-50 (mean: 31.95) have participated. - Exposure assessment:
- measured
- Details on exposure:
- The test method was the closed epicutaneous application of the method described in Frosch (Finn Chamber assay, modified Duhring-chamber test was selected). 70 μl of the test substances were applied once for a period of 24 hours on the skin of the back, using a Large Finn Chamber on Scanpor . After removal of the patch the skin were observed after 1, 6, 24, 48, 72 and 144 hours.
The following parameters were evaluated:
- erythema
- edema
- dandruff
- formation of fissures
Results and discussion
- Results:
- Edenor C 16, Ti Edenor dist. and Edenor ME Rückstand II were tolerated by all subjects without responses. Lorol RG neutral, Lorol RG alkalisch, Polyresidal N, Polyresidal F, Ti Edenor ME 05 F, Edenor ME Palm, Ke 491, Edenol B 35 and Magnesiumsllikat caused only slight erythema in individual cases.
Lorol technisch and Triacetin caused only slight erythema, but slightly more common than the above-mentioned substances.
Edenor C 12 and C Edenor ME 60-10 caused slight edema, slight dandruff and light to medium, very occasionally more erythema.
All test chemicals were below the 1% irritation potential of the internal standard substance Texapon N 25.
Any other information on results incl. tables
Calculating the irritation scores in percent relative to the control Texpapon N 25 (100%)
|
Applicant's summary and conclusion
- Conclusions:
- Edenor C 16 92/94 - FS008 and Edenor Ti dest. (Fettsäure C 16 - 18 + 18') - FSOlO were tolerated by all subjects without responses. So the substances possess a very good skin compatibility.
- Executive summary:
The following substances were investigated for skin irritation in 20 healthy volunteers in a closed epicutaneous test:
1 = Lorol, technisch (Fettalkohol C12 - 18) - FA010
2 = Lorol RG, neutral (Fettalkohol dest. Rückstand) - FA015
3 = Lorol RG, alkalisch (Fettalkohol dest. Rtickstand) - FA015
4 = Edenor C 12 98/100 (Fettsäure C 12) - FS004
5 = Edenor C 16 92/94 (Fettsäure C 16) - FS008
6 = Edenor Ti dest. (Fettsäure C 16 - 18 + 18') - FSOlO
7 = Polyresidal N (Rückstand gesättige Fettsäuren) - FS016
8 = Polyresidal F (Rtückstand ungesättigte Fettsäuren) - FSOl7
9 = Edenor ME C 6 - 10 (Fettsäuremethylester C 8) - FSMEOOl
10 = Edenor ME Ti 05 F (Fettsauremethylester C 14 - 18 + 16' - 18') - FSME005
11 = Edenor ME Palm (Fettsäuremethylester C: Palm) - FSME013
12 = Edenor ME Rückst. II (Fettsäuremethylester dest. Rückstand) - FSME 016
13 = Ke 491 (FS8 - 10 + TMPr + NPG) - EST00l
14 = Eden01 B 35 (FE18EPO) + 2/6 Guer) - EST002
15 = Triacetin - GLY00l
16 = Magnesiumsilikat - SNS004
A concentration of 50 % was used. The test substances were applied for 24 hours.
There were only slight reactions, except Edenor C 12 and Edenor ME C 6 - 10, which caused little stronger reactions.
The irritation index of the test substances was generally lower than that of the internal standard 1 % Texapon N 25.
Edenor C 12 and Edenor ME C 6 - 10 are considered to possess a sufficient skin compatibility while the other substances are considered to possess a good to very good skin compatibility.
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