Registration Dossier
Registration Dossier
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EC number: 277-475-8 | CAS number: 73455-75-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study, protocol internally validated for distinguishing non-irritants from irritants
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: OECD draft testing guideline 492 (RECONSTRUCTED HUMAN CORNEA-LIKE EPITHELIUM (RHCE) TEST METHOD FOR IDENTIFYING CHEMICALS NOT REQUIRING CLASSIFICATION AND LABELLING FOR EYE IRRITATION OR SERIOUS EYE DAMAGE)
- Principles of method if other than guideline:
- Determination of eye damage in a reconstructed three dimensional human cornea model (EpiOcular™)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Hydrogen [29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cuprate(1-), compound with dodecylamine (1:1)
- EC Number:
- 277-475-8
- EC Name:
- Hydrogen [29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cuprate(1-), compound with dodecylamine (1:1)
- Cas Number:
- 73455-75-1
- Molecular formula:
- C32H15CuN8O3S.C12H27N.H
- IUPAC Name:
- Hydrogen [29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cuprate(1-), compound with dodecylamine
- Details on test material:
- - Physical state: solid
- Analytical purity: 99.2% (HPLC, detection at 280 nm)
- Purity test date: 2014
- Lot/batch No.: 130005P040
- Expiration date of the lot/batch:
- Stability under test conditions: stable
- Storage condition of test material: at room temperature
- Other: pH was ca. 5 (undiluted test substance, moistened with water)
Constituent 1
Test animals / tissue source
- Species:
- human
- Strain:
- other: not applicable
- Details on test animals or tissues and environmental conditions:
- not applicable
The EpiOcularTM model (OCL-200) is a three-dimensional non-keratinized tissue construct composed of normal human derived epidermal keratinozytes used to model the human corneal epithelium. The EpiOcularTM tissues (surface 0.6 cm²) are cultured on specially prepared cell culture inserts (MILLICELLs, 10 mm ∅) and are commercially available as kits (EpiOcular™ 200), containing 24 tissues on shipping agarose.
To assess the ability of the test material to directly reduce MTT a pretest was performed.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: yes (tissue incubations for positive and negative controls included)
- Amount / concentration applied:
- 0.05 mL (33 mg)
- Duration of treatment / exposure:
- 6 hours
- Observation period (in vivo):
- 18h
- Number of animals or in vitro replicates:
- Two tissue samples were used per group.
- Details on study design:
- Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the testsubstance treated epidermal tissues is compared to that of negative control tissues. The
quotient of the values indicates the relative tissue viability.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: Viability (%)
- Basis:
- other: culture 1
- Score:
- 33.7
- Max. score:
- 100
- Reversibility:
- not specified
- Irritation parameter:
- other: Viability (%)
- Basis:
- other: culture 2
- Score:
- 16.2
- Max. score:
- 100
- Reversibility:
- not specified
Any other information on results incl. tables
Methyl acetate was used as positive control and deionised water as negative control and both gave the results to satisfy acceptance criteria.
Methyl acetate decreased the mean viability to 24% of control cultures.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The mean viability was less than 60%, therefore the substance is considered to be irritating to eyes.
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