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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 629-776-4 | CAS number: 308065-15-8
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
- Study period:
- 18 Dec 1981 - 27 Jan 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment (analytical purity of test substance not specified, readings at 4 and 48 hours only)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: D.O.T. Corrosivity (Skin Irritation on Rabbits,. 49 CFR 173.240)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- analytical purity of test substance not specified, readings at 4 and 48 h only
- Principles of method if other than guideline:
- An amount of 0.5 mL test substance was applied on a square surgical gauze patch measuring 2.5 cm x 2.5 cm and two single layers thick. The patch was applied on the clipped back of the animals and the entire trunk was wrapped with impermeous material such as rubberized cloth. After 4 hours, the patch was removed and the skin evaluated for corrosion immediately and after 48 h following application. Corrosion was considered to have resulted if the substance caused destruction or irreversible alteration of the tissue.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Methyl laurate
- EC Number:
- 203-911-3
- EC Name:
- Methyl laurate
- Cas Number:
- 111-82-0
- Molecular formula:
- C13H26O2
- IUPAC Name:
- methyl laurate
- Details on test material:
- - Name of test material (as cited in study report): methyl dodecanonate
- Substance type: Fatty acid methyl ester
- Physical state: liquid, amber
- Analytical purity: not indicated, treated as 100% pure
- Storage condition of test material: room temperature, glass container
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Isaacs lab stock
- Weight at study initiation: > 2000 g
- Acclimation period: at least 7 days
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not required, untreated sites of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 48 hours
Reading time points: 4 and 48 h - Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: back skin, patch size: 2.5 cm x 2.5 cm
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- mean out of all 6 animals
- Time point:
- other: 4 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 48 h (end of observation time)
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- mean out of all 6 animals
- Time point:
- other: 48 h
- Score:
- 0.17
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 48 h (end of observation time)
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- mean out of all 6 animals
- Time point:
- other: 4 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: no effect
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- mean out of all 6 animals
- Time point:
- other: 48h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: no effect
- Irritant / corrosive response data:
- No corrosivity occurred. The test substance caused no edema but only slight erythema, that persists to the end of the observation time of 48 h.
Any other information on results incl. tables
Table 1: Individual erythema and edema scores
|
Erythema score at |
Edema score at |
||
Animal number |
4h |
48h |
4h |
48h |
1 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
3 |
1 |
1 |
0 |
0 |
4 |
1 |
0 |
0 |
0 |
5 |
0 |
0 |
0 |
0 |
6 |
0 |
0 |
0 |
0 |
Mean scores |
0.33 |
0.17 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: no classified
DSD: not classified
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.
