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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 269-124-2 | CAS number: 68187-77-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- other: read across from analogue substance
- Adequacy of study:
- key study
- Study period:
- 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Good study, no GLP compliance
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according 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
- Molecular formula:
- Not applicable
- IUPAC Name:
- Castor Oil, sulfated, sodium salt
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: breeding center Padre Antonio
- Weight at study initiation:2 - 3 kg
- Housing: stainless steel cage 1472 Tecniplast with autowashing (10 sec. every hour)
- Diet: full pellet, ad libitum.
- Water: municipal water filtered with Seitz filter, ad libitum.
- Acclimation period: 7 days
- Healt check: 24 hours before treatment.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±1
- Humidity (%): 55±15
- Air changes (per hr):8
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 ml/animale - Duration of treatment / exposure:
- one injection
- Observation period (in vivo):
- 1, 24, 48, 72h
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- SCORING SYSTEM: according to DAIZE test
TOOL USED TO ASSESS SCORE: fluorescein, and UV lamp (365 nm)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 1,2,3 and 5
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- not reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 4 and 6
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal: 1 and 5
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- animal: 2, 3, 4 and 6
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 1
- Time point:
- 24/48/72 h
- Score:
- ca. 2.66
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 2 and 3
- Time point:
- 24/48/72 h
- Score:
- ca. 2.33
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 4, 5 and 6
- Time point:
- 24/48/72 h
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal: 1 and 6
- Time point:
- 24/48/72 h
- Score:
- ca. 2.6
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal: 2, 4 and 5
- Time point:
- 24/48/72 h
- Score:
- ca. 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal: 3
- Time point:
- 24/48/72 h
- Score:
- ca. 1.6
- Max. score:
- 2
- Reversibility:
- not reversible
Any other information on results incl. tables
| tissue | observation period | rabbit | Mean | |||||
| 1 | 2 | 3 | 4 | 5 | 6 | |||
| Cornea | 1h | 0 | 0 | 0 | 0 | 0 | 0 | 0.00 |
| 24h | 1 | 1 | 1 | 0 | 1 | 0 | 0.66 | |
| 48h | 1 | 1 | 1 | 0 | 1 | 0 | 0.66 | |
| 72h | 1 | 1 | 1 | 0 | 1 | 0 | 0.66 | |
| 7days | 1 | 1 | 1 | 0 | 1 | 0 | 0.66 | |
| Iris | 1h | 0 | 0 | 0 | 0 | 0 | 0 | 0.00 |
| 24h | 1 | 0 | 0 | 0 | 1 | 0 | 0.33 | |
| 48h | 1 | 0 | 0 | 0 | 1 | 0 | 0.33 | |
| 72h | 1 | 0 | 0 | 0 | 1 | 0 | 0.33 | |
| 7days | 1 | 0 | 0 | 0 | 1 | 0 | 0.33 | |
| Conjunctiva | 1h | 2 | 2 | 2 | 2 | 2 | 2 | 2.00 |
| 24h | 3 | 3 | 3 | 2 | 2 | 2 | 2.50 | |
| 48h | 3 | 2 | 2 | 2 | 2 | 2 | 2.16 | |
| 72h | 2 | 2 | 2 | 2 | 2 | 2 | 2.00 | |
| 7days | 1 | 1 | 1 | 1 | 1 | 1 | 1.00 | |
| chemosis | 1h | 2 | 2 | 2 | 2 | 2 | 2 | 2.00 |
| 24h | 3 | 2 | 2 | 3 | 3 | 3 | 2.83 | |
| 48h | 3 | 2 | 2 | 2 | 2 | 3 | 2.33 | |
| 72h | 2 | 2 | 1 | 1 | 1 | 2 | 1.50 | |
| 7days | 1 | 0 | 1 | 1 | 0 | 1 | 0.66 | |
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance was tested for eye irritation following 67/548/ECC method. Under the experimental conditions the conjunctivae score was > 2 and not reversible for the duration of the test for more thna 2/3 of animals.
- Executive summary:
The substance was tested for eye irritation following 67/548/ECC method. Under the experimental conditions the conjunctivae score was > 2 and not reversible for the duration of the test for more thna 2/3 of animals.
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.
