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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
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
Remarks:
The study was conducted according to the guideline in effect at the time of study conduct.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-amino-3-hydroxy-N'-[(E)-(2,3,4-trihydroxyphenyl)methylidene]propanehydrazide hydrochloride
EC Number:
940-411-0
Cas Number:
1353749-74-2
Molecular formula:
C10H14ClN3O5
IUPAC Name:
2-amino-3-hydroxy-N'-[(E)-(2,3,4-trihydroxyphenyl)methylidene]propanehydrazide hydrochloride
Details on test material:
-Purity: 100%

Test animals / tissue source

Species:
other: bovine
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Bovine corneas, obtained as a by-product from freshly slaughtered animals


Test system

Vehicle:
water
Controls:
yes
Amount / concentration applied:
- Concentration (if solution): 750 μL of 20% (w/v) dilution in sterile, deionized water for each cornea


Duration of treatment / exposure:
4 hours; Then, after washing, the corneas were incubated with fluorescein solution in a horizontal position (anterior side up) for approximately 90 minutes at 32 ± 1ºC.
Number of animals or in vitro replicates:
Five corneas
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours

SCORING SYSTEM: Sina classification system

TOOL USED TO ASSESS SCORE: The initial opacity was determined for each cornea using an Electro Design OP-KIT opacitometer. The optical density at 490 nm (OD490) was determined using a fluorescein solution and a Molecular Devices Vmax kinetic microplate reader.

Results and discussion

In vivo

Results
Irritation parameter:
other: in vitro score
Basis:
mean
Time point:
other: 4 hours
Score:
10.9
Remarks on result:
other: The maximum score is ≥55.1.

Any other information on results incl. tables

The Bovine Corneal Opacity and Permeability Assay (BCOP) was used to assess the potential ocular irritancy of the test substance, as measured by changes in opacity and permeability (to fluorescein) in isolated bovine corneas. Based on changes in corneal opacity and permeability (relative to the control corneas), an in vitro score was determined. See Table 1.

Table 1: In Vitro Score

Mean Opacity Value

Mean OD490 Value

In Vitro Score

10.3

0.045

10.9

Applicant's summary and conclusion

Interpretation of results:
other: Mild Irritant
Remarks:
Criteria used for interpretation of results: OECD GHS
Conclusions:
This study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).
Considered a mild eye irritant
Executive summary:

The Bovine Corneal Opacity and Permeability Assay (BCOP) was used to assess the potential ocular irritancy of the test substance, as measured by changes in opacity and permeability (to fluorescein) in isolated bovine corneas after 4 hours of exposure. Based on changes in corneal opacity and permeability (relative to the control corneas), the in vitro score was determined to be 10.9. The test substance is considered a mild irritant.