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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 06 November 2017 to 06 December 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
422-350-7
EC Name:
-
Cas Number:
5575-48-4
Molecular formula:
C13H30O3Si
IUPAC Name:
Decyltrimethoxysilane
impurity 1
Reference substance name:
not applicable - unknown impurities of Decyltrimethoxysilane
Molecular formula:
not applicable - unknown impurities of Decyltrimethoxysilane
IUPAC Name:
not applicable - unknown impurities of Decyltrimethoxysilane
Test material form:
liquid

In vitro test system

Test system:
human skin model
Vehicle:
unchanged (no vehicle)
Details on test system:
RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm (EPI-200) Reconstituted Human Epidermis
- Tissue batch number(s): 25859

TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37°C

NUMBER OF REPLICATE TISSUES:
Triplicate
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 µL

NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 µL

POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 µL
Duration of treatment / exposure:
60 ± 1 minute (25 minutes at room temperature and 35 minutes at 37°C, 5% CO2, ≥95% RH)
Duration of post-treatment incubation (if applicable):
42 ± 4h post-treatment incubation (at 37°C, 5% CO2, ≥ 95% RH)
Number of replicates:
Triplicate

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
Mean value
Value:
3.03
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
Optical Density (OD) values obtained with blanks were higher than 0.1 (0.152). However, the spectrophotometer was fully validated and had passed all required tests. The OD values for blanks observed in this study are consistent with historical data using this spectrophotometer in the laboratory and meet our current internal acceptance criteria of blank OD values <0.194. Therefore this deviation is not considered significant.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Decyltrimethoxysilane reduced the tissue viability to 3.03% and therefore meets the criteria for classification as irritant to the skin according to Regulation (EC) No.1272/2008.
Executive summary:

The in vitro skin irritation of Decyltrimethoxysilane was determined in accordance with the OECD Guideline for Testing of Chemicals 439 during a GLP-compliant study. This in vitro risk assessment assay predicts the Skin irritation potential of a chemical by measurement of its cytotoxic effect on the EpiDerm™ tissue model.

Prior to testing, the test substance was checked for interference with water and/or MTT. No interference was identified.

Skin irritation of the test substance and controls was evaluated in triplicate. After 60 ± 1 minutes exposure on the surface of the EpiDerm™ reconstructed human epidermis and a 42 ± 4h post-exposure incubation time, viability of the tissues was assessed and compared to the negative control.

The percentage of viability obtained with Decyltrimethoxysilane was 3.03%, therefore it has to be considered as irritant to the skin according to the criteria laid down in the OECD Guideline for Testing of Chemicals 439.

The test item met the criteria for classification as irritant to the skin according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.