Registration Dossier

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
Reference
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)

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
Reference
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)

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.