Registration Dossier
Registration Dossier
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EC number: 269-124-2 | CAS number: 68187-77-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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: 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
- Molecular formula:
- Not applicable
- IUPAC Name:
- Castor Oil, sulfated, sodium salt
- Test material form:
- liquid
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)
SCORING SYSTEM: according to OECD guideline 404
Erithema, Edema
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 1 and 4
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 2 and 5
- Time point:
- 24/48/72 h
- Score:
- ca. 1.6
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 3 and 6
- Time point:
- 24/48/72 h
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 1 and 5
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 2 and 4
- Time point:
- 24/48/72 h
- Score:
- ca. 0.6
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 3 and 6
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- 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 |
| edema | 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:
- GHS criteria not met
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance was tested for skin irritation following method 29/7/1983 , 67/548 CEE. Under the experimental conditions the substance is not skin irritant.
- Executive summary:
The substance was tested for skin irritation following method 29/7/1983 , 67/548 CEE. Six NZW rabbits were shaved and tested with occlusive method for 4 hours. Under the experimental conditions the substance is not skin irritant.
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