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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 262-996-5 | CAS number: 61788-67-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Old study, no guideline followed.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: 67/548 CEE
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Castor oil, sulfated, sodium salt
- EC Number:
- 269-123-7
- EC Name:
- Castor oil, sulfated, sodium salt
- Cas Number:
- 68187-76-8
- IUPAC Name:
- Castor oil, sulfated, sodium salt
- Test material form:
- other: viscous liquid
- Details on test material:
- - Name of test material: Castor oil, sulfated, sodium salt
- Molecular formula: no data
- Molecular weight : no data
- Smiles notation: no data
- InChl: no data
- Substance type: no data
- Physical state:li quid
- Analytical purity:
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Isomers composition:
- Purity test date:
- Lot/batch No.:
- Expiration date of the lot/batch:
- Radiochemical purity (if radiolabelling):
- Specific activity (if radiolabelling):
- Locations of the label (if radiolabelling):
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions:
- Storage condition of test material:
- Other:
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Housing:iron stainless steel cage model 1472 "tecniplast"
- Diet : pellet, ad libitum
- Water : municipal filtered water, ad libitum
- Acclimation period:7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):20 ± 1°C
- Humidity (%): 55 ± 15%
- Air changes (per hr):8 per hour
- Photoperiod (hrs dark / hrs light):
IN-LIFE DATES: From: To:
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g - Duration of treatment / exposure:
- one application/ 4 hours
- Observation period:
- 24, 48, 72 hours , 5, and 7 days
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: ~ 10 cm^2
- % coverage:
- Type of wrap if used:multiple foil surgical gauze (2.5 X 2.5 cm). The gauze is fixed by ipoallergenic adhesive bandage (Blenderm BM). The entire animal's trunk is protected by elastic bandage (Acrylastic Beyersdorf)
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:
SCORING SYSTEM: according to OECD guideline 404
Erithema, Edema
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 7 days
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 7 days
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
Any other information on results incl. tables
| erithema | check | 1 | 2 | 3 | 4 | 5 | 6 | mean |
| 24h | 1 | 2 | 2 | 1 | 2 | 2 | 1.66 | |
| 48h | 1 | 2 | 2 | 1 | 2 | 2 | 1.66 | |
| 72h | 1 | 1 | 2 | 1 | 1 | 2 | 1.33 | |
| 5d | 0 | 1 | 1 | 1 | 1 | 1 | 0.83 | |
| 7d | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| erithema | check | 1 | 2 | 3 | 4 | 5 | 6 | mean |
| 24h | 1 | 1 | 0 | 1 | 1 | 0 | 0.66 | |
| 48h | 1 | 1 | 0 | 1 | 1 | 0 | 0.66 | |
| 72h | 1 | 0 | 0 | 0 | 1 | 0 | 0.33 | |
| 5d | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| 7d | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on results the product Castrol oil don't presente any signs of irritation
- Executive summary:
Castrol oil is tested by Decree 29/7/1983 67/548/CEE .Test item is applied on skin of six Newzeland albino rabbit. Based on results the product Castrol oil don't present any signs of 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.
