Registration Dossier
Registration Dossier
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EC number: 946-046-3 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 Feb 2017 to 03 May 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
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:
- 4-sulphophthalic acid
- EC Number:
- 201-881-6
- EC Name:
- 4-sulphophthalic acid
- Cas Number:
- 89-08-7
- Molecular formula:
- C8H6O7S
- IUPAC Name:
- 4-sulphophthalic acid
- Reference substance name:
- 3-sulphophthalic acid
- EC Number:
- 267-576-5
- EC Name:
- 3-sulphophthalic acid
- Cas Number:
- 67892-43-7
- Molecular formula:
- C8H6O7S
- IUPAC Name:
- 3-sulphophthalic acid
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- water
- Test material form:
- liquid
Constituent 1
Constituent 2
Constituent 3
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Remarks:
- bovine cornea
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 100ml of a 10X solution
- Duration of treatment / exposure:
- single exposure/ one day
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Value:
- 158
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Remarks:
- Minimal Essential Media
- Positive controls validity:
- valid
- Remarks:
- 100% Ethanol
- Remarks on result:
- positive indication of irritation
- Remarks:
- Severe/corrosive eye irritant
- Irritation parameter:
- in vitro irritation score
- Value:
- 162.35
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- fluorescein leakage
- Value:
- 0.29
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
Any other information on results incl. tables
The positive control, 100 % ethanol, was categorized and received and the negative control, Minimal Essential Material (MEM), was used as a 10% solution in 0.9% saline.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Remarks:
- Severe/corrosive eye irritant
- Conclusions:
- The material was considered a severe/corrosive eye irritant. The material was classified in Category 1.
- Executive summary:
To determine the potential for ocular irritation using an alternative to the Draize methodology, a study based on the methodology described in the current OECD Guideline for the Testing of Chemicals No. 437 was conducted. Three bovine corneas per group were dosed with 0.75 ml of Reaction Mass of 4- sulphophthalic acid (CAS 89-08-7) and 3-sulphophthalic acid (CAS 67892-43-7), 3:1 ratio, Minimal Essential Media (MEM, negative control), or 100% ethanol (positive control). Following a 10-minute exposure for each group of dosed corneas, opacity measurements and sodium fluorescein permeability were determined. The MEM solution is then removed from the anterior chamber and replaced with 1.0 ml of 0.4% sodium fluorescein solution. After 90 min the fluid from the posterior chamber is removed and the amount of dye that passed through the cornea is measured as the optical density at 490 nm by a plate reader. For the test substance, the in vitro irritancy score (IVIS) is 162.35, corneal opacity score is 158.00, and the permeability score is 0.290. Based on an IVIS of greater than 55, and as defined in OECD Guideline No. 437, the reaction mass of sulphophthalic acid was determined to be GHS Category 1 and was considered a severe/corrosive eye irritant.
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