Kieselguhr, soda ash flux-calcined

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

The study was performed between 26 May 2010 and 28 May 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study performed in accordance with GLP and accepted protocol.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Materials and methods

Principles of method if other than guideline:

The purpose of this study was to determine the eye irritation potential of the test material using the SkinEthic Reconstituted Human Corneal model (HCE, SkinEthic Laboratories, Nice, France) after a treatment period of 10 minutes. The test is based on the hypothesis that irritant chemicals are able to penetrate the stratum corneum of the SkinEthic RHC model and are sufficiently cytotoxic to cause cell death in the underlying cell layers

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Kieselguhr, soda ash flux-calcined

EC Number:

272-489-0

EC Name:

Kieselguhr, soda ash flux-calcined

Cas Number:

68855-54-9

Molecular formula:

SiO2

IUPAC Name:

silanedione

Details on test material:

Sponsor's identification: soda-ash flux calcined kieselguhr
CAS Number : 68855-54-9
Description : white powder
Lot number : 211184
Date received : 10 February 2010
Expiry date : 31 December 2013
Storage conditions: room temperature in the dark

Test animals / tissue source

Species:

other: Reconstituted Corneal Epithelium

Test system

Amount / concentration applied:

TEST MATERIAL
- Amount applied: Tissues were treated with 30 mg of the test material.

VEHICLE
Test material was used as supplied

CONTROLS:
- Amount applied: 30 µL of Solution A was applied as a negative control and 30 µL of of SDS 1.0% (w/v) as a positive control. Solution A was comprised of Na2HPO4 0.142 g/L, Glucose 1.802 g/L, HEPES 7.149 g/L, KCl 0.224 g/L and NaCl 7.597 g/L. Sodium Dodecyl Sulphate (SDS) was prepared as a 1% w/v solution in sterile distilled water.

Duration of treatment / exposure:

Cultures were exposed for 10 minutes to the test material.

Observation period (in vivo):

Skin cultures were examined after three hours.

Number of animals or in vitro replicates:

All test substances were tested in triplicate (including controls)

Results and discussion

In vivo

Results

Irritation parameter:

other: relative mean tissue viability

Basis:

mean

Time point:

other: 10 minutes

Score:

99.1

Remarks on result:

other: %

Irritant / corrosive response data:

The mean OD540 values and mean viabilities for each treatment group are given in Table 1.
The relative mean viability of the test material treated tissues after a 10 minute exposure was 99.1%.
It was considered unnecessary to proceed with tissue histopathology.

The qualitative evaluation of tissue viability is presented in Table 2.
The test material and negative control material treated tissues appeared blue which was considered to be indicative of viable tissue. The positive control material treated tissues appeared blue/white which was considered to be indicative of semi viable tissue

Any other information on results incl. tables

Table 1: Assessment of Eye Irritation Potential – Viability of RHC Tissues

Material	Mean Tissue Viability	Mean OD540	Viability (%)
Negative Control	1.036	1.006	100*
	0.975
Positive Control	0.540	0.537	53.4
	0.533
Test Material	0.989	0.997	99.1
	1.005

*=      The mean viability of the negative control tissues is set at 100%

Table 2: Qualitative Evaluation of Tissue Viability (MTT uptake visual evaluation)

Material	Score
	Tissue 1	Tissue 2
Negative Control	-	-
Positive Control	+	+
Test Material	-	-

MTT Visual Scoring Scheme of SkinEthic Tissues

-     =  Blue tissue (viable)

+    =  Blue/White tissue (semi viable)

++  =  Tissue completely white (dead)

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information

Conclusions:

According to the protocol followed the test material was considered to be a Non Irritant The quality criterion required for the acceptance of results in the test was satisfied