Registration Dossier
Registration Dossier
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EC number: 202-700-3 | CAS number: 98-79-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 September 2016 - 23 September 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
Materials and methods
Test guideline
- 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:
- July, 2013
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Pidolic acid
- EC Number:
- 202-700-3
- EC Name:
- Pidolic acid
- Cas Number:
- 98-79-3
- Molecular formula:
- C5H7NO3
- IUPAC Name:
- 5-oxo-L-proline
- Test material form:
- solid: particulate/powder
- Details on test material:
- white solid crystalline powder
Constituent 1
- Specific details on test material used for the study:
- Batch number: 20140124
Storage Conditions: At room temperature
Test animals / tissue source
- Species:
- cattle
- Details on test animals or tissues and environmental conditions:
- Freshly isolated bovine cornea (at least 9 month old donor cattle)
Test system
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount / concentration applied:
- 20% solution (w/v) in saline
- Duration of treatment / exposure:
- 240 minutes
- Number of animals or in vitro replicates:
- Three
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- 72.95
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The calculated mean IVIS for the substance was 72.95 (threshold for serious eye damage: IVIS ≥ 55). According to OECD 437 the test item is classified as serious eye damaging.
- Executive summary:
An in vitro study was performed to assess the corneal damage potential of the substance by means of the BCOP assay using fresh bovine corneae. With the negative control (saline) neither an increase of opacity nor permeability of the corneae could be observed (mean IVIS= 1.17). The positive control (10% (w/v) Benzalkonium chloride in saline) showed clear opacity effects on the corneae (mean IVIS =106.19) corresponding to a classification as serious eye damaging (CLP/EPA/GHS (Cat 1)). Relative to the negative control, the substance caused a distinct increase of the corneal opacity. The calculated mean IVIS was 72.95 (threshold for serious eye damage: IVIS ≥ 55). According to OECD 437 the substance is classified as serious eye damaging.
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