reaction product of alumina and sulfuric acid

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 03. May 2016 to 18. May 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Remarks:

Epi Ocular (TM) Human Cornea Model

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)

Version / remarks:

adopted Jul. 2015

Deviations:

no

Principles of method if other than guideline:

Normal, human-derived kratinocytes are cultured to form a stratified, squamous epithelium consisting of highly organised basal cells, similar to the human cornea. Eye irritant materials are defined by an decrease of cell viability. The cell viability is measured by dehydrogenase (present in all mitochondria) conversion of MTT (3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazoliumbromide) int a blue formazan salt, which can be determined quantitatively by a plate spectral photometer at 570nm.

GLP compliance:

yes (incl. QA statement)

Remarks:

certified by Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, Kaiser-Friedrich-Str. 7, D-55116 Mainz, Germany

Test material

Test material information

Constituent 1

Reference substance name:

reaction product of alumina and sulfuric acid

EC Number:

812-508-7

Cas Number:

1093112-19-6

Molecular formula:

unspecified, UVCB substance

IUPAC Name:

reaction product of alumina and sulfuric acid

Test material form:

solid: particulate/powder

Test animals / tissue source

Species:

human

Strain:

other: keratinocytes, forming an epithelium similar to a human cornea

Remarks:

EpiOcular(TM) kit, derived from MatTek, In Vitro Life Science Laboratories, Mylinskè Nivy 73, 82105 Bratislava, Slovakia

Details on test animals or tissues and environmental conditions:

The tissues are cultured in specially prepared cell culture insert with aporus membrane through which nutrients can pass.
The tissue surface is 0.6 cm².
The cells are not transformed or infected with genes to induce an extended life span.

Test system

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

Tissue 1: 53.6 mg
Tissue 2: 48.5 mg

Duration of treatment / exposure:

6 h

Duration of post- treatment incubation (in vitro):

25 min. post soak, 18h post treatment incubation

Number of animals or in vitro replicates:

2 x 2

Details on study design:

blank: isopropanol, measured in 8 wells
negative control: water
positive control: methyl acetate

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Remarks:

relative absorbance values [%]

Run / experiment:

2 concentrations in duplicate

Value:

>= 0 - <= 99.1

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Applicant's summary and conclusion

Conclusions:

In the EpiOcular(TM) Eye Irritation Test Sulfuric acid, reaction product with alumina is considerd as not eye irritant.