Registration Dossier
Registration Dossier
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EC number: 215-158-8 | CAS number: 1308-14-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 4 hours
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Guideline study to GLP performed on Chromium Hydroxide
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Chromium (III) hydroxide
- EC Number:
- 215-158-8
- EC Name:
- Chromium (III) hydroxide
- Cas Number:
- 1308-14-1
- Molecular formula:
- Cr (OH)3
- IUPAC Name:
- chromium (III) hydroxide
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Physical state/Appearance: green powderBatch: 001Purity: >99%Expiry Date: not suppliedStorage Conditions: room temperature in the dark
Test animals / tissue source
- Species:
- cattle
- Details on test animals or tissues and environmental conditions:
- Eyes from adult cattle (typically 12 to 60 months old) were obtained from a local abattoir as a by-product from freshly slaughtered animals. The eyes were excised by an abattoir employee after slaughter, and were placed in Hanks’ Balanced Salt Solution (HBSS) supplemented withantibiotics (penicillin at 100 IU/mL and streptomycin at 100 μg/mL). They were transported to the test facility over ice packs on the same day of slaughter. The corneas were prepared immediately on arrival.
Test system
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount / concentration applied:
- Applied as 20% solution
- Duration of treatment / exposure:
- 240 minutes at 32 C
- Duration of post- treatment incubation (in vitro):
- Opacity was observed immediately after rinsing at the end of exposure, and sodium fluorescin was added and incubated at 32 C for 90 minutes prior to observing permeability
- Number of animals or in vitro replicates:
- Three eyes per treatment type
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- Treated eyes
- Value:
- 3.2
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- Positive control
- Value:
- 103.8
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
The negative control gave opacity of ≤4.1 and permeability ≤0.105. The negative control acceptance criteria were therefore satisfied.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material showed low level of response and can be considered to be non-irritant to eyes with respect to GHS criteria.
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