Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Silybum marianum extract
- Molecular formula:
- Not applicable
- IUPAC Name:
- Silybum marianum extract
- Test material form:
- liquid
- Details on test material:
- The test matérial contains 0.5% of tocophérol for stability
1
Test animals / tissue source
- Species:
- other: bovine
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Duration of treatment / exposure:
- 10 min
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- test item replicate 1
- Value:
- ca. 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- test item replicate 2
- Value:
- >= 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- test item replicate 3
- Value:
- >= 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The result obtained shows that LIPOLAMI is considered as non irritant.
- Executive summary:
The objective of this work is the determination of eye irritation potential of LIPOLAMI milk thistle ER according OECD 437 method.
The result obtained shows that LIPOLAMI is considered as non irritant.
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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