Registration Dossier
Registration Dossier
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EC number: 604-018-5 | CAS number: 137433-01-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Scientific and detailed study report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (2S,3S,5R)-2-hexyl-3-hydroxy-5-(phenylmethoxy)-Hexadecanoic acid compd. with (S)-α-methylbenzenemethanamine (1:1)
- EC Number:
- 604-018-5
- Cas Number:
- 137433-01-3
- Molecular formula:
- C29 H50 O4 . C8 H11 N
- IUPAC Name:
- (2S,3S,5R)-2-hexyl-3-hydroxy-5-(phenylmethoxy)-Hexadecanoic acid compd. with (S)-α-methylbenzenemethanamine (1:1)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 48 mg per rabbit in one eye
- Observation period (in vivo):
- up to 72 hours
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 1 H
- Score:
- 12
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 24 H
- Score:
- 10
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 48 H
- Score:
- 2.67
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 72 H
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 72 H
Applicant's summary and conclusion
- Conclusions:
- Ro 40 -8168/002 is a minimal eye irritant and does not require labeling for eye irritation potential under EU Criteria
- Executive summary:
According to EU Criteria, Ro 40 -8168/002 does not require R-36.
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.
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