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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 04. Feb. 2016 to 25. Feb. 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

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 431 (In Vitro Skin Corrosion: Human Skin Model Test)
Deviations:
no
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

Constituent 1
Chemical structure
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

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Cell source:
other: not specified, EpiDerm(TM), procured from MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia
Source strain:
not specified
Justification for test system used:
species of interest: Human, three-dimensional skin model, comprising a reconstructed epidermis witha functional stratum corneum
appication topically as may occur by skin contact
Vehicle:
other: the solid test substance was applied together with 25 µl of water
Details on test system:
commercially available EpiDerm(TM)-kit procured from MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia
designation: EPI-200-EACH
Amount/concentration applied:
Tissue 1: 24.8 mg (3 minutes incubation) and 25.3 mg (1 hour incubation)
Tissue 2: 25.1 mg (3 minutes incubation) and 24.5 mg (1 hour incubation)
Duration of treatment / exposure:
2 minutes or 1 hour
Duration of post-treatment incubation (if applicable):
incubation with MTT reagent for 3 h
Number of replicates:
2 x 2

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Remarks:
relative absorbance value (%)
Run / experiment:
after 3 minutes treatment: 93.4%, after 1 h treatment: 93.7%
Vehicle controls validity:
not examined
Negative controls validity:
valid
Remarks:
water demin.
Positive controls validity:
valid
Remarks:
KOH, 8.0 mol/l
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Sulfuric acid, reaction product with alumina is considered as non-corrosive in the Human Skin Model Test.