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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- 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:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Dermal irritation potential of the substance was evaluated in rats following exposure to 25% test concentration for 24 h.
- GLP compliance:
- not specified
- Remarks:
- This information is not available in the RAC opinion
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
- Details on test material:
- - Name of test material (as cited in study report): Decanoic acid
Constituent 1
Test animals
- Species:
- rabbit
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- other: PEG
- Controls:
- not specified
- Amount / concentration applied:
- approximately 27-30 mg/cm2 or 25% test concentration
- Duration of treatment / exposure:
- 24 h
- Observation period:
- Daily observations for 15 d
- Number of animals:
- 5 males and 5 females
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Time point:
- 24 h
- Score:
- >= 1 - < 2
- Reversibility:
- fully reversible within: 14 d
- Remarks on result:
- other: developed into scaling and scabs (grade 1 to 2)
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Reversibility:
- not specified
- Remarks on result:
- other: No details given
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Reversibility:
- not specified
- Remarks on result:
- other: No details given
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- other: No details given
- Irritant / corrosive response data:
- Irritation was observed which was reversible within 15 d.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Under the study conditions, the substance was considered to be irritating to rabbit skin.
- Executive summary:
A study was conducted to evaluate the skin irritation potential of the constituent decanoic acid in rats according to EU method B.3 and OECD guideline 402 in compliance with GLP. In this study, 5 male and female rats were exposed to 27 -30 mg/cm2 of 25% test substance in PEG for 24 h. Erythema grade (1 -2) irritation reactions were observed in all animals after application, which developed into scaling and scabs (grade 1 to 2). The reactions were completely reversible after 14 d of observation. Hence, under the study conditions, the substance was considered to be irriating to the skin (Talvioja, 2006, cited in ECHA RAC opinon, 2013).
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