Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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EC number: 273-179-8 | CAS number: 68952-95-4 A complex combination of fatty acids, neutral vegetable-oil, proteins, and other minor components produced by boiling vegetable-oil soapstock with mineral acid and, optionally, further separating the oil phase acidulated soapstock from the aqueous phase.
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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Reviewed studies reported in European Chemicals Agency (ECHA) Committee for Risk Assessment (RAC) opinion, but with limited study details.
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Annex 1: Background document to the opinion proposing harmonised classification and labelling at Community level of octanoic acid, EC number: 204-677-5; CAS number: 124-07-2.
- Author:
- ECHA Committee for Risk Assessment (RAC)
- Year:
- 2 013
- Bibliographic source:
- CLH-O-0000002589-62-03/A1
- Report date:
- 2013
Materials and methods
- Study type:
- other: Human skin ex vivo
- Endpoint addressed:
- skin irritation / corrosion
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Transcutaneous Elektrical Resistance Test (TER); OECD guideline 430
- Qualifier:
- according to guideline
- Guideline:
- other: EpiDerm (reconstituted human epidermis model)
Test material
- Reference substance name:
- Decanoic acid
- EC Number:
- 206-376-4
- EC Name:
- Decanoic acid
- Cas Number:
- 334-48-5
- Molecular formula:
- C10H20O2
- IUPAC Name:
- decanoic acid
- Reference substance name:
- Nonanoic acid
- EC Number:
- 203-931-2
- EC Name:
- Nonanoic acid
- Cas Number:
- 112-05-0
- Molecular formula:
- C9H18O2
- IUPAC Name:
- nonanoic acid
- Details on test material:
- - Name of test material (as cited in study report): Nonanoic acid and Decanoic acid
Constituent 1
Constituent 2
Method
- Type of population:
- general
- Subjects:
- Study 1: Decanoic acid was tested in Transcutaneous Elektrical Resistance Test (TER) - a human skin ex vivo test
Study 2 and 3: Nonanoic and melted decanoic acid were tested in EpiDerm (reconstituted human epidermis model) - two in vitro tests - Ethical approval:
- not specified
- Route of exposure:
- other: ex-vivo and in vitro tests
- Reason of exposure:
- other: not applicable
- Details on exposure:
- Decanoic acid (study 1): Transcutaneous Elektrical Resistance Test (TER) was conducted according to OECD guideline 430 following exposure to 100% test concentration for 24 h.
Nonanoic and melted decanoic acid (study 2 and 3): In vitro Epiderm skin irritation test was conducted following exposure to 100% test concentration for 15 min and 60 min respectively.
Results and discussion
- Results of examinations:
- Study 1: 29.9 ± 5.4 kΩ/disc (a value of ≤11 kΩ/disc indicates that a substance could produce a corrosive effect on human skin in vivo)
Study 2 and 3: Irritant; Tissue viability <50% or >50% and IL1α release 3x increased.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the study, the two substances can be considered to be at least irritating to the skin.
- Executive summary:
Standard human ex-vivo and in vitro tests were conducted to evaluate the skin irritation potential of nonanoic and decanoic acid. A transcutaneous electrical resistance test (TER) (i.e., a human ex-vivo test) was conducted with decanoic acid according to OECD guideline 430 following exposure to 100% test concentration for 24 h. As per the TER test criteria, a value of ≤11 kΩ/disc indicates that a substance could produce a corrsive effect on human skin in vivo. Under the conditions of the study, a TER of 29.9 ± 5.4 kΩ/disc indicates that the substance is not corrosive to skin. Two in vitro EpiDerm skin irritation tests were conducted with nonanoic and melted decanoic acid following exposure to 100% of the respective substances for 15 min and 60 min in reconstituted human epidermis models. The tissue viability was <50% or >50% and IL1α release 3x increased indicative of at least skin irritation potential. Overall, under the conditions of the studies, the two substances can be considered to be at least irritating to the skin (ECHA RAC opinion, 2013).
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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