Registration Dossier
Registration Dossier
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EC number: 273-258-7 | CAS number: 68955-20-4 This substance is identified by SDA Substance Name: C16-C18 alkyl alcohol sulfuric acid sodium salt and SDA Reporting Number: 19-062-04.
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP Guideline study. However, according to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Lack on details of test substance. However details were achieved from the sponsor.
- GLP compliance:
- yes
Test material
- Reference substance name:
- 73296-89-6 (purity 30%)
- IUPAC Name:
- 73296-89-6 (purity 30%)
- Details on test material:
- - Name of test material (as cited in study report): trade name
- Physical state: Opaque white liquid
- Analytical purity: 30% a.i.
- Lot/batch No.: TGD010.0080
- Storage condition of test material: No data
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- According to Guideline.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- not applicable
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24+48+72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24+48+72 h
- Score:
- 0.2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24+48+72 h
- Score:
- 2.8
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24+48+72 h
- Score:
- 3.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information R41 Criteria used for interpretation of results: EU
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