Registration Dossier
Registration Dossier
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EC number: 810-213-8 | CAS number: 1370461-06-5
Endpoint summary
Administrative data
Description of key information
Skin irritation: OECD TG 431/ OECD TG 439 (BASF SE, 2015): not corrosive, not irritating
Eye irritation: EpiOcular (BASF SE, 2015): not irritating
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: Guideline- and GLP-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)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- testing lab.
- Species:
- other: not applicable (in vitro test)
- Strain:
- other: not applicable (in vitro test)
- Details on test animals or test system and environmental conditions:
- Tissue model: EPI-200
Tissue Lot Number: 21630 (Certificate of Analysis see appendix)
Origin: MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia - Type of coverage:
- other: not applicable (in vitro test)
- Preparation of test site:
- other: not applicable (in vitro test)
- Controls:
- other: not applicable (in vitro test)
- 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)
Reference
The substance was not able to reduce MTT directly.
Corrosion test
Exposure period: 3 min |
||||||
Test substance |
|
tissue 1 |
tissue 2 |
mean |
SD |
CV (%) |
NC |
mean OD570 |
1.998 |
2.002 |
2.000 |
0.003 |
|
|
viability (% of NC) |
99.9 |
100.1 |
100.0 |
0.1 |
0.1 |
CAS 1370461-06-5 |
mean OD570 |
1.865 |
2.060 |
1.977 |
0.116 |
|
|
viability (% of NC) |
94.8 |
103.0 |
98.9 |
5.8 |
5.9 |
PC |
mean OD570 |
0.394 |
0.268 |
0.331 |
0.089 |
|
|
viability (% of NC) |
19.7 |
13.4 |
16.5 |
4.5 |
27.0 |
Exposure period: 1 hour |
||||||
Test substance |
|
tissue 1 |
tissue 2 |
mean |
SD |
CV (%) |
NC |
mean OD570 |
2.169 |
1.811 |
1.990 |
0.253 |
|
|
viability (% of NC) |
109.0 |
91.0 |
100.0 |
12.7 |
12.7 |
CAS 1370461-06-5 |
mean OD570 |
2.265 |
2.060 |
2.163 |
0.145 |
|
|
viability (% of NC) |
113.8 |
103.5 |
108.7 |
7.3 |
6.7 |
PC |
mean OD570 |
0.154 |
0.148 |
0.151 |
0.005 |
|
|
viability (% of NC) |
7.8 |
7.4 |
7.6 |
0.2 |
3.0 |
Irritation test:
|
Exposure period: 1 hour + recovery time |
|||||||
Test substance |
|
tissue 1 |
tissue 2 |
tissue 3 |
mean |
SD |
CV (%) |
|
NC |
mean OD570 |
2.219 |
2.302 |
2.342 |
2.288 |
0.063 |
|
|
|
viability (% of NC) |
97.0 |
100.6 |
102.4 |
100.0 |
2.7 |
2.7 |
|
CAS 1370461-06-5 |
mean OD570 |
2.399 |
2.365 |
2.227 |
2.330 |
0.091 |
|
|
|
viability (% of NC) |
104.8 |
103.4 |
97.3 |
101.9 |
4.0 |
3.9 |
|
PC |
mean OD570 |
0.073 |
0.078 |
0.087 |
0.080 |
0.007 |
|
|
|
viability (% of NC) |
3.2 |
3.4 |
3.8 |
3.5 |
0.3 |
8.9 |
|
NC, negative control
PC, positive control
SD, standard deviation
CV, coefficient of variation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
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: Reliable and GLP-conformant study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Regulation (EU) No 1152/2010
- Qualifier:
- according to guideline
- Guideline:
- other: OECD (2014a) Draft Proposal for a New Test Guideline (EpiOcularTM)
- 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 methodes incl. tables"
- Observation period (in vivo):
- see "Any other information on materials and methodes incl. tables"
- Number of animals or in vitro replicates:
- not applicable (in vitro test)
Reference
The tested substance did not reduce MTT directly.
Results of EpiOcular test:
Test substance |
|
tissue 1 |
tissue 2 |
mean |
Inter-tissue variability (%) |
NC |
mean OD570 |
1.745 |
1.788 |
1.767 |
|
|
viability (% of NC) |
98.8 |
101.2 |
100.0 |
2.4 |
CAS 1370461-06-5 |
mean OD570 |
1.902 |
2.065 |
1.984 |
|
|
viability (% of NC) |
107.7 |
116.9 |
112.3 |
9.2 |
PC |
mean OD570 |
0.365 |
0.321 |
0.343 |
|
|
viability (% of NC) |
20.6 |
18.2 |
19.4 |
2.5 |
NC, negative control
PC, positive control
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation and corrosion was tested with a turnkey testing strategy in vitro. The test substance was applied to a 3 -dimensional reconstructed human epidermis model for either 3 minutes or 1 hour for corrosivity testing, or for 1 hour + 42 hours recovery time for irritation testing. Cell viability was used as an indicator for tissue damage. Mean tissue viability for all conditions tested was 98.9 -108.7% compared to negative control. Therefore, Aluminum, [(2E)-2-butenedioato(2-)- O1]hydroxy- is considered not irritant and not corrosive to the skin.
Eye irritation potential was tested in the EpiOcularTM test (OECD (2014a) Draft Proposal for a New Test Guideline). Therefore, the test substance was applied to a 3D tissue model for the human corneal epithelium for 6 hours, followed by 18 hours incubation.
Cell viability was used as an indicator for tissue damage. Mean tissue viability was 112% compared to negative control. Conclusively, Aluminum, [(2E)-2-butenedioato(2-)- O1]hydroxy- did not show potential for eye irritation or serious eye damage.
Justification for selection of skin irritation / corrosion endpoint:
Guideline- and GLP-conformant study with robust study summary
Justification for selection of eye irritation endpoint:
Reliable and GLP-conformant study with robust study summary
Justification for classification or non-classification
The available data do not fulfill the criteria laid out in Regulation (EC) 1272/2008 (CLP). Therefore, a non-classification of Aluminium, [(2E)-2 -butenedioato(2 -)-O1]hydroxy- 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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