Registration Dossier
Registration Dossier
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EC number: 601-498-8 | CAS number: 117899-42-0
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:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: HetCam
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- rel-(4aR,5aS,6aS,6bS,9R,9aS,11S,11aS,11bR)-9a,11b-dimethyl-9-(2-methyl-1,3-dioxolan-2-yl)tetradecahydrospiro[cyclopenta[1,2]phenanthro[8a,9-b]oxirene-3,2'-[1,3]dioxolane]-9,11-diol
- EC Number:
- 601-498-8
- Cas Number:
- 117899-42-0
- Molecular formula:
- C25H38O7
- IUPAC Name:
- rel-(4aR,5aS,6aS,6bS,9R,9aS,11S,11aS,11bR)-9a,11b-dimethyl-9-(2-methyl-1,3-dioxolan-2-yl)tetradecahydrospiro[cyclopenta[1,2]phenanthro[8a,9-b]oxirene-3,2'-[1,3]dioxolane]-9,11-diol
Constituent 1
Test animals / tissue source
- Species:
- chicken
- Details on test animals or tissues and environmental conditions:
- Chorioallantoic memebrane (CAM) of fertile chicken egg
Test system
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Duration of treatment / exposure:
- 20 secondes
- Duration of post- treatment incubation (in vitro):
- The CAM was observed for a period of 5 minutes for possible occurrence of effects
- Number of animals or in vitro replicates:
- 4
Results and discussion
In vitro
Results
- Irritation parameter:
- other: Luëpke score
- Value:
- 0
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under our experimental conditions, the test article Hydralfoxy was considered as non-irritant to the eye and does not require any labelling.
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