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EC number: 689-137-0 | CAS number: 247569-56-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 2013-July 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study has been performed according to OECD and/or EC guidelines and according to GLP principles.This study has been performed according to OECD and/or EC guidelines and according to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-fluoro-5-methanesulfonylbenzoic acid
- EC Number:
- 689-137-0
- Cas Number:
- 247569-56-8
- Molecular formula:
- C8 H7 F O4 S
- IUPAC Name:
- 2-fluoro-5-methanesulfonylbenzoic acid
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Lot: 270002C
Purity: 99.86%
Expiry: 20 February 2014
Storage Conditions: Room temperature in the dark
Constituent 1
Test animals / tissue source
- Species:
- other: cattle
- Strain:
- not specified
Test system
- Vehicle:
- physiological saline
- Controls:
- yes
- Duration of treatment / exposure:
- 240 minutes
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 240 minutes
- Score:
- 42.4
Any other information on results incl. tables
Corneal Opacity and Permeability Measurement
Individual and mean corneal opacity measurements and individual and mean corneal permeability measurements are given in Table 1.
Corneal Epithelium Condition
The condition of each cornea post treatment is given in Table 2.
The corneas treated with the test item were cloudy post treatment. The corneas treated with the
negative control item were clear post treatment. The corneas treated with the positive control
item were cloudy post treatment.
In Vitro Irritancy Score
The In Vitro irritancy scores are summarized as follows:
Treatment In Vitro Irritancy Score
Test Item 42.4
Negative Control 9.4
Positive Control 93.6
Criterion for an Acceptable Test
The positive control In Vitro Irritancy Score was within the range of 65.9 to 140.8.
The positive control acceptance criterion was therefore satisfied.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- 2-Fluoro-5-(methylsulfonyl) benzoic acid (CAS Number 247569-56-8) was considered not to be an ocular corrosive or severe irritant.
However the IVIS was 42.4 which indicated that although the test item was not considered to be a severe ocular irritant or corrosive, according to
OECD Guidelines for the Testing of Chemicals No. 437, the test item can be presumed to have the ability to induce some degree of ocular irritation. - Executive summary:
Introduction
A study was performed to assess the ocular irritancy potential of the test item to the isolated bovine cornea.
Method
The test item was applied at a concentration of 20% w/v in 0.9% w/v sodium chloride solution for 240 minutes.
Negative and positive control items were tested concurrently.
The two endpoints, decreased light transmission through the cornea (opacity) and increased passage of sodium
fluorescein dye through the cornea (permeability) were combined in an empirically derived formula
to generate an In Vitro Irritancy Score (IVIS)
Interpretation
A test item that induces an In Vitro Irritancy Score 55.1 is defined as an ocular corrosive or severe irritant.
Results
The In Vitro irritancy scores are summarized as follows:
Treatment In Vitro Irritancy Score
Test Item 42.4
Negative Control 9.4
Positive Control 93.6
Conclusion
2-Fluoro-5-(methylsulfonyl) benzoic acid (CAS Number 247569-56-8) was considered not to be an ocular corrosive or severe irritant.
However the IVIS was 42.4 which indicated that although the test item was not considered to be a
severe ocular irritant or corrosive, according to OECD Guidelines for the Testing of Chemicals No.
437, the test item can be presumed to have the ability to induce some degree of ocular irritation.
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