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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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
Qualifier:
according to guideline
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
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

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 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

Resultsopen allclose all
Irritation parameter:
other: mean tissue viability
Basis:
other: corrosion test
Time point:
other: 3 min
Score:
105
Remarks on result:
other: CV 10.4%
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%
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
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
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:

1sttest 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

 

4thtest 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

 

Applicant's summary and conclusion