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

Eye irritation

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: OECD (2014a) Draft Proposal for a New Test Guideline (EpiOcular(TM))

Test guideline 2

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

Test material information

Constituent 1

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 EpiOcular^TM test. Since the data from the EpiOcular^TM 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 EpiOcular^TMtest:

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