Registration Dossier
Registration Dossier
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EC number: 847-971-4 | CAS number: 2363126-59-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2020-05-19 til 2020-05-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guidelineopen allclose all
- 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)
- Version / remarks:
- 09 October 2017
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guidance Document on ‘The Collection of Tissues for Histological Evaluation and Collection of Data’. Series on Testing and Assessment, No. 160
- Version / remarks:
- July 6, 2018
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Manganese-(II)-hexacyanomanganate (II) sodium salts
- EC Number:
- 847-971-4
- Cas Number:
- 2363126-59-2
- Molecular formula:
- NaxMny[Mn(CN)6]z X = 1.2-1.4; Y = 1.0; Z = 0.8-0.85
- IUPAC Name:
- Manganese-(II)-hexacyanomanganate (II) sodium salts
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- Oxidane
- Test material form:
- solid: particulate/powder
Constituent 1
impurity 1
- Specific details on test material used for the study:
- See section "Test material information"
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Not applicable
Test system
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0,75 mL
- Concentration (if solution): 20% w/v solution in sodium chloride 0.9% w/v.
VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution): 0.9%
- Lot/batch no. (if required): 19E28BB1B
- Purity: 0.9% - Duration of treatment / exposure:
- 240 minutes
- Duration of post- treatment incubation (in vitro):
- 32 ± 1 ºC for 90 minutes
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
QUALITY CHECK OF THE ISOLATED CORNEAS
good, all checked for clarity and no visible damages
NUMBER OF REPLICATES
3 per group
NEGATIVE CONTROL USED
0.9 % saline
SOLVENT CONTROL USED (if applicable)
yes
POSITIVE CONTROL USED
20% w/v Imidazole, batch 183503, Supplier Fisher Scientific
APPLICATION DOSE AND EXPOSURE TIME
see text fields
TREATMENT METHOD: [closed chamber / open chamber]
closed chamber
POST-INCUBATION PERIOD: yes/no. If YES please specify duration
Yes: The medium from the anterior chamber was removed and replaced with 1 mL of sodium fluorescein solution (5 mg/mL). The dosing holes were plugged and the holders incubated, anterior chamber uppermost, at 32 ± 1 ºC for 90 minutes.
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: 3x
METHODS FOR MEASURED ENDPOINTS:
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of [UV/VIS spectrophotometry / microtiter plate reader] (OD490)
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: please specify if the decision criteria as indicated in the TG was used: UN GHS
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- 1.5
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system:
none
DEMONSTRATION OF TECHNICAL PROFICIENCY:
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
- Range of historical values if different from the ones specified in the test guideline: not applicable
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to UN GHS Classification, the test item is given No Category classification under the conditions of the test.
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