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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 266-369-7 | CAS number: 66469-15-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The source study was conducted with isooctadecanoic acid. The read across source substance is considered a structural analogue taking into account the physico-chemical properties (surface active properties, logKow, water solubility) and the chemical structure of the test item (potassium soap of isooctadecanoic acid). Besides published data on skin irritation properties of long chain fatty acids and their salts are considered relevant for this read across approach. The results of the source substance are considered relevant for human health endpoints skin irritation, eye irritation and consecutive risk assessment of local effects. See read across document for further details.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Isooctadecanoic acid
- EC Number:
- 250-178-0
- EC Name:
- Isooctadecanoic acid
- Cas Number:
- 30399-84-9
- Molecular formula:
- C18H36O2
- IUPAC Name:
- 16-methylheptadecanoic acid
- Test material form:
- liquid
- Details on test material:
- Name of test material (as cited in study report): Prisorine 3505
Physical state: liquid- Analytical purity: approx. 100 %
Storage condition of test material: at ambient temperature in the dark
Other: stable at storage conditions
Constituent 1
- Specific details on test material used for the study:
- Name of test material (as cited in study report): Prisorine 3505 Acide Isostearique
Physical state: liquid
Analytical purity: no data
Other: light yellow
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- other: untreated sites of the same animal served as control
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 5 hours after removal of the dressing and 24, 48, 72 hours and 7 days after application
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Other effects:
- Slight reactional dryness together with decrease in skin suppleness were also observed. Clear irritative phenomena were observed. They remained during 24 hours without any changes, and then decreased regularly. On day 6, not any irritation was seen, but slight changes in skin structure persisted until day 10.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to Annex I of Regulation (EC) 1272/2008, the test item has no obligatory labelling requirement for skin irritation.
- Executive summary:
Under the conditions of the present OECD 404 study, a single application of the test item to rabbits produced irritant effects, which were fully reversible within 6 days in all animals. Neither mortalities nor significant clinical signs of toxicity were observed. According to Annex I of Regulation (EC) 1272/2008, the test item has no obligatory labelling requirement for skin irritation.
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.
