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Toxicological information

Eye irritation

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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:
2017

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

Constituent 1
Chemical structure
Reference substance name:
Pidolic acid
EC Number:
202-700-3
EC Name:
Pidolic acid
Cas Number:
98-79-3
Molecular formula:
C5H7NO3
IUPAC Name:
(2S)-5-oxopyrrolidine-2-carboxylic acid
Test material form:
solid: particulate/powder
Details on test material:
white solid crystalline powder
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.