Registration Dossier

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: Guideline- and GLP-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)
GLP compliance:
yes (incl. QA statement)
Remarks:
testing lab.

Test material

Constituent 1
Chemical structure
Reference substance name:
sra-[(2E)-2-butenedioato(2-)hydroxy aluminium]
EC Number:
810-213-8
Cas Number:
1370461-06-5
Molecular formula:
C4 H3 Al O5
IUPAC Name:
sra-[(2E)-2-butenedioato(2-)hydroxy aluminium]
Details on test material:
- Name of test material (as cited in study report): Aluminum, [(2E)-2-butenedioato(2-)- O1]hydroxy-
- Physical state: solid / white
- Analytical purity: 85.8 g/ 100 g
- Batch No.:13-0001-2
- Storage condition of test material: room temperature

Test animals

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

Test system

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)

Results and discussion

Any other information on results incl. tables

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

 

Applicant's summary and conclusion