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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: GLP- and guideline-conformant study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: OECD (2014a) Draft Proposal for a New Test Guideline (EpiOcular(TM))
Qualifier:
according to guideline
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
Principles of method if other than guideline:
EpiOcular(TM): The objective of this in vitro test is to assess the eye irritation potential of the test substance using the reconstructed human ocular model EpiOcular(TM). The test is based on the experience that irritant chemicals produce cytotoxicity in human reconstructed cornea after a short term topical exposure. After application of the test material to the surface of the EpiOcularTM tissue the induced cytotoxicity (= loss of viability) is measured by a colorimetric assay.
GLP compliance:
yes (incl. QA statement)
Remarks:
testing lab.

Test material

Constituent 1
Chemical structure
Reference substance name:
1,3,5-Benzenetricarboxylic acid, copper(2+) salt (2:3)
Cas Number:
309721-49-1
Molecular formula:
C9 H6 O6 . 3/2 Cu
IUPAC Name:
1,3,5-Benzenetricarboxylic acid, copper(2+) salt (2:3)
Details on test material:
- Name of test material (as cited in study report): 1,3,5-Benzenetricarboxylic acid, copper(2+) salt
- Physical state: solid
- Analytical purity: 98.6 g/100 g (100 g/100 g minus water content)
- Lot/batch No.: AP199.6
- Storage condition of test material: Room temperature, under nitrogen (air sensitive)

Test animals / tissue source

Species:
other: not applicable (in vitro test)
Strain:
other: not applicable (in vitro test)

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: not applicable (in vitro test)
Duration of treatment / exposure:
see "Any other information on materials and methods incl. tables"
Observation period (in vivo):
see "Any other information on materials and methods incl. tables"
Number of animals or in vitro replicates:
not applicable (in vitro test)

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Run / experiment:
mean viability of three tissues [%]
Value:
82.7
Vehicle controls validity:
valid
Negative controls validity:
not examined
Positive controls validity:
valid

Any other information on results incl. tables

The test substance was not able to reduce MTT directly.

Only a slight reduction of viability was observed in the EpiOcularTM test. Since the data from the EpiOcularTM test alone were sufficient for assessment of the eye irritation potential of the test substance, no further tests were conducted.

The following data were obtained from the EpiOcularTMtest:

Test substance

 

tissue 1

tissue 2

mean

CV [%]

NC

mean OD570

1.476

1.518

1.497

 

Viability

98.6

101.4

100.0

2.8

1,3,5-Benzenetricarboxylic accid, copper (2+) salt (2:3)

mean OD570

1.268

1.207

1.237

 

Viability

84.7

80.7

82.7

4.0

PC

mean OD570

0.296

0.352

0.324

 

Viability

19.7

23.5

21.6

3.8

Viability is depicted as [% of NC]

NC, negative control

PC, positive control

CV, coefficiton of variation

 

Applicant's summary and conclusion