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
- Study period:
- 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: vitro method test according to the Official Joirnal of the Republic of France (n° 300). December, 26, 1996.
- Principles of method if other than guideline:
- The principle is based on the observation of the irritant effects (hyperemia, hemorrhage, coagulation) which may occur wuthin five minutes after placing a test item onto the chorio-allantoic membrane (CAM) of an embryonated henn egg, on the tenth day of incubation. Depending on the presence of these effects and their appearance time, a score is established. The mean scores obtained from four eggs allows to note the test item and to classify according to its irritant potential.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- pentazinc dichloride octahydroxide
- Cas Number:
- 12167-79-2
- Molecular formula:
- Zn5(OH)8Cl2·H2O
- IUPAC Name:
- pentazinc dichloride octahydroxide
Constituent 1
Test animals / tissue source
- Species:
- chicken
- Strain:
- other: White Leghorn
- Details on test animals or tissues and environmental conditions:
- Egg embryonated
Test system
- Controls:
- other: Positif contro: 3.2 and 0.4% Lauryl sulfobetaine (CAS 14933-08-5) in saline solution / Negatif control Lauryl sulfobetaine in saline solution
- Duration of treatment / exposure:
- 300 mg
- Observation period (in vivo):
- 5 minutes
- Number of animals or in vitro replicates:
- four
Results and discussion
In vitro
Results
- Irritation parameter:
- other: Hyperemia, hemorrage and Coagulation (Opacity and/or Thrombosis)
- Value:
- ca. 10
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- The subtance is irritant to eyes
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