Registration Dossier
Registration Dossier
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EC number: 813-272-8 | CAS number: 309721-49-1
Endpoint summary
Administrative data
Description of key information
OECD 431 and 439 (BASF SE, 2015): not corrosive but skin irriation potential
EpiOcular(TM) test (BASF SE, 2015): no potential for eye irriation
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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
- 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
- Species:
- other: not applicable (in vitro test system)
- Strain:
- other: not applicable (in vitro 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)
- 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
Reference
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
Eye irritation
Link to relevant study records
- 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
- 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.
- Species:
- other: not applicable (in vitro test)
- Strain:
- other: not applicable (in vitro test)
- 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)
- 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
Reference
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
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In vitro skin irritation and corrosion testing was performed with a turnkey strategy. Corrosivity and potential for irritation were assessed as ability of the test substance to decrease tissue viability. While the test substance was not corrosive (tissue viability >90%) , it was irritating in the EpiDerm(TM) assay under the test conditions chosen (tissue viability <50%).
Eye irritation testing was performed in vitro with the EpiOcular(TM) test, in which the irritation potential of the test substance is assessed as its ability to decrease tissue viability. The mean tissue viability was >80%, therefore the test substance did not show potential for eye irriation in the EpiOcular(TM) test under the test conditions chosen.
Justification for selection of skin irritation / corrosion endpoint:
GLP- and guideline-conformant study
Justification for selection of eye irritation endpoint:
GLP- and guideline-conformant study
Effect level: empty Endpoint conclusion: Adverse effect observed
Justification for classification or non-classification
1,3,5-Benzenetricarboxylic acid, copper(2+) salt showed a skin irritation potential in the EpiDerm(TM) test in vitro. Therefore, according to Regulation (EU) 1272/2008 (CLP) classification as irritating to skin (Cat. 2, H315) is justified.
1,3,5-Benzenetricarboxylic acid, copper(2+) salt did not show eye irriation potential. Therefore, non-classification for eye damage is warranted.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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