Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Rheinland-Pfalz, Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht

Test material

Constituent 1
Chemical structure
Reference substance name:
Silicic acid, aluminum magnesium sodium salt
EC Number:
234-919-5
EC Name:
Silicic acid, aluminum magnesium sodium salt
Cas Number:
12040-43-6
Molecular formula:
Na(0.017-1.739)Mg(0.008-0.823)Al(0.002-0.2473)SiO(2.018-3.837)
IUPAC Name:
aluminium(3+) magnesium(2+) sodium tris(oxosilanebis(olate))
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
Name Silicic acid Aluminium Magnesium Sodium Salt
Batch no. code # 1107274003
Appearance white powder
Composition Silic acid Aluminium Magnesium Sodium Salt
CAS No. 12040-43-5
EINECS-No. 234-919-5
Purity > 99 %
Homogeneity homogeneous
Stability stable at room temperature
Solubility poorly soluble
Expiry date 01. Nov. 2018
Storage room temperature (20 ± 5 °C), dry

In vitro test system

Test system:
artificial membrane barrier model
Source species:
other: synthetic macromolecular bio-barrier
Control samples:
yes, concurrent negative control

Test animals

Species:
other: synthetic biobarrier
Details on test animals or test system and environmental conditions:
The Corrositex® test is an in vitro procedure by which the assessment of corrosivity is not carried out in live animals.
The Corrositex® test refers to the penetration of the membrane barrier which is measured by a change in the colour of a pH indicator dye.

Test system

Controls:
yes, concurrent positive control
Duration of treatment / exposure:
60 min

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
penetration time (in minutes)
Run / experiment:
negative control
Value:
> 60
Negative controls validity:
valid
Irritation / corrosion parameter:
penetration time (in minutes)
Run / experiment:
positive control
Value:
ca. 12
Positive controls validity:
valid
Irritation / corrosion parameter:
penetration time (in minutes)
Run / experiment:
test item
Value:
> 60
Remarks on result:
no indication of irritation

Any other information on results incl. tables

The controls showed the following results: The negative control showed no break-through within the observation time of 60 min.

The positive control showed clear corrosive effects after 12 minutes and is consequently classified as a corrosive substance belonging to UN Packing Group II.

Therefore the test item (substance category 2 according to the categorisation) is classified as a non-corrosive substance.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Silicic acid Aluminium Magnesium Sodium Salt is considered as not corrosive in the Corrositex® - Test.