Aluminum, [(2E)-2-butenedioato(2-)-.kappa.O1]hydroxy-

Skin irritation / corrosion

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)

Test guideline 2

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

Test material information

Constituent 1

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