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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion

Remarks:

in vitro

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:

OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

Test guideline 3

Qualifier:

according to guideline

Guideline:

OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)

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 N2

Test animals

Species:

other: not applicable (in vitro test system)

Strain:

other: not applicable (in vitro test system)

Test system

Type of coverage:

other: not applicable (in vitro test system)

Preparation of test site:

other: not applicable (in vitro test system)

Controls:

other: not applicable (in vitro test system)

Duration of treatment / exposure:

see "Any other information on materials and methodes incl. tables"

Observation period:

see "Any other information on materials and methodes incl. tables"

Number of animals:

not applicable (in vitro test system)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: mean tissue viability

Basis:

other: corrosion test

Time point:

other: 3 min

Score:

105

Remarks on result:

other: CV 10.4%

Results 2

Irritation parameter:

other: mean tissue viability

Basis:

other: corrosion test

Time point:

other: 1 hour

Score:

94.6

Remarks on result:

other: CV 5.9%

Results 3

Irritation parameter:

other: mean tissue viability

Basis:

other: irritation test

Time point:

other: 1 hour + 42 hours recovery

Score:

44.1

Remarks on result:

other: high variation (27.6%), therefore repetition

Results 4

Irritation parameter:

other: mean tissue viability

Basis:

other: irritation test

Time point:

other: 1 hour + 42 hours recovery

Score:

32.1

Remarks on result:

other: value for inter-tissue variance was out of acceptance range, therefore repetiton

Results 5

Irritation parameter:

other: mean tissue viability

Basis:

other: irritation test

Time point:

other: 1 hour + 42 hours recovery

Score:

9.8

Remarks on result:

other: CV 54.9%, however study was considered acceptable

Any other information on results incl. tables

The test substance was not able to reduce MTT directly.

No reduction of viability was observed in the corrosion test. The irritation test was conducted as four separate tests, one of which was disregarded due to a technical error. The viability of test substance treated samples was 44.1±27.6%, 32.1± 59.7%, and 9.8 ± 54.9%. Although the coefficient of variation is high, overall the data are sufficient to assess the irritation potential of the test substance.

The following data were obtained from the corrosion test:

exposure period 3 min
Test substance		tissue 1	tissue 2	mean	OD	CV [%]
NC	mean OD570	1.891	1.837	1.864	0.038
	Viability	101.4	98.6	100.0	2.0	2.0
1,3,5-Benzenetricarboxylic accid, copper (2+) salt (2:3)	mean OD570	1.827	2.117	1.972	0.205
	Viability	98.0	113.6	105.8	11.0	10.4
PC	mean OD570	0.246	0.265	0.255	0.013
	Viability	13.2	14.2	13.7	0.7	5.3

 

exposure period 1 hour
Test substance		tissue 1	tissue 2	mean	OD	CV [%]
NC	mean OD570	2.189	2.266	2.227	0.054
	Viability	98.3	101.7	100.0	2.4	2.4
1,3,5-Benzenetricarboxylic accid, copper (2+) salt (2:3)	mean OD570	2.195	2.018	2.107	0.125
	Viability	98.6	90.6	94.6	5.6	5.9
PC	mean OD570	0.237	0.138	0.187	0.070
	Viability	10.6	6.2	8.4	3.1	37.4

 

The following data were obtained from irritation testing:

1^sttest run
Test substance		tissue 1	tissue 2	tissue 3	mean	OD	CV [%]
NC	mean OD570	2.158	2.139	2.157	2.151	0.011
	Viability	100.3	99.4	100.3	100.0	0.5	0.5
1,3,5-Benzenetricarboxylic accid, copper (2+) salt (2:3)	mean OD570	0.653	1.151	1.041	0.948	0.262
	Viability	30.3	53.5	48.4	44.1	12.2	27.6
PC	mean OD570	0.092	0.072	0.077	0.080	0.010
	Viability	4.3	3.4	3.6	3.7	0.5	13.0

 

4^thtest run
Test substance		tissue 1	tissue 2	tissue 3	mean	OD	CV [%]
NC	mean OD570	2.070	1.918	1.962	1.983	0.078
	Viability	104.4	96.7	98.9	100.0	3.9	3.9
1,3,5-Benzenetricarboxylic accid, copper (2+) salt (2:3)	mean OD570	0.071	0.258	0.252	0.193	0.106
	Viability	3.6	13.0	12.7	9.8	5.4	54.9
PC	mean OD570	0.068	0.065	0.061	0.065	0.004
	Viability	3.4	3.3	3.1	3.3	0.2	5.5

Viability is depicted as [% of NC]

NC, negative control

PC, positive control

CV, coefficiton of variation