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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 273-114-3 | CAS number: 68938-07-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Limited study details are provided, preGLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Both abraded and non-abraded tests were performed
- GLP compliance:
- no
Test material
- Reference substance name:
- Neodecanoic acid
- EC Number:
- 248-093-9
- EC Name:
- Neodecanoic acid
- Cas Number:
- 26896-20-8
- Molecular formula:
- C10H20O2
- IUPAC Name:
- neodecanoic acid
- Details on test material:
- - Name of test material (as cited in study report): Versatic 10
- Physical state: liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- No additional data
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): Assumed 100% - Duration of treatment / exposure:
- 24 hours
- Observation period:
- Daily for 7 days.
- Number of animals:
- 4 male and 4 female
- Details on study design:
- TEST SITE
- Area of exposure: between shoulders and hindquarters
- % coverage: 2 x 2 cm
- Type of wrap if used: occlusive
SCORING SYSTEM:
No erythema = 0
Pale pink = 1
Redness = 2
Severe redness = 3
Beet redness = 4
No edema = 0
Soft skin = 1
Edema = 2
More definite edema = 3
Severe edema - 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0.52
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Non-abraded skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0.52
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0.28
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Non-abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0.31
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Abraded skin
Any other information on results incl. tables
| Sex | Test | Response | 24 hours | 48 hours | 72 hours | 7 days |
| F | Non-abraded | Erythema | 1 | 1 | 0 | 1 |
| Edema | 0-1 | 0-1 | 0 | 0 | ||
| F | Abraded | Erythema | 0-1 | 0-1 | 0 | 0-1 |
| Edema | 0 | 0 | 0 | 0 | ||
| F | Non-abraded | Erythema | 1 | 1 | 1 | 0 |
| Edema | 0-1 | 0-1 | 0-1 | 0 | ||
| F | Abraded | Erythema | 1 | 0-1 | 1 | 0 |
| Edema | 1 | 0 | 0 | 0 | ||
| M | Non-abraded | Erythema | 0-1 | 0-1 | 0 | 0 |
| Edema | 0-1 | 0-1 | 0 | 0 | ||
| M | Abraded | Erythema | 1 | 0-1 | 1 | 0 |
| Edema | 1 | 0-1 | 0 | 0 | ||
| M | Non-abraded | Erythema | 1 | 0-1 | 0 | 0 |
| Edema | 0-1 | 0-1 | 0 | 0 | ||
| M | Abraded | Erythema | 1-2 | 1 | 0-1 | 0 |
| Edema | 1 | 1 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- other:
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Mild and transient erythema and edema was observed in all animals. After 7 days, the skin of half of the test rabbits was slightly dry and beginning to flake.
- Executive summary:
In this study male and female rabbits were exposed via occluded patch for 24 hours to 0.5 ml of neodecanoic acid to assess the irritation potential. The skin of the rabbits was abraded in half of the animals and non-abraded in the other half. Mild and transient erythema and edema was noted in all animals. All reactions were virtually fully reversible within 7 days post exposure. After, 7 days, the skin of half of the test rabbits was slightly dry and beginning to flake.
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.
