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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 614-482-0 | CAS number: 68439-46-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP-Guideline study without restrictions. According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Alcohols, C10-16, ethoxylated
- EC Number:
- 500-182-6
- EC Name:
- Alcohols, C10-16, ethoxylated
- Cas Number:
- 68002-97-1
- IUPAC Name:
- 68002-97-1
- Details on test material:
- - Name of test material (as cited in study report): trade name
- Ethoxylation degree: 2
- Physical state: Slightly cloudy, colourless liquid
- Analytical purity: 100% a.i. (info by sponsor)
- Lot/batch No.: No data
- Storage condition of test material: Room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- According to Guideline.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 21 days
- Number of animals:
- 6
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- out of 6 animals
- Time point:
- other: mean (24,48,72 h)
- Score:
- 0.8
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of 6 animals
- Time point:
- other: mean (24,48,72 h)
- Score:
- 0.4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- Under the condition of this test classification is not justified.
- Executive summary:
The effects observed are not increasing, but rather point to a slower recovery and with scores of 1 or 2. Additionally, the gross pathology does not present thickening, ulcer, superficial blistering, hyperkeratosis or flaking during healing.
Hence, the effects seen are closer to a mild irritant than one with a clear R38. Due to the fact that all other tested members of this category do not show a skin irritating potential under the correct test conditions, these effects do not justify the classification R38.
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.
