4-Methyl-N-[3-(triethoxysilyl)propyl]-2-pentanimine

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26 October 2018 - 13 December 2018

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)

Version / remarks:

29 July 2016

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

467-100-8

EC Name:

-

Cas Number:

116229-43-7

Molecular formula:

C15H33NO3Si

IUPAC Name:

(E)-(4-methylpentan-2-ylidene)[3-(triethoxysilyl)propyl]amine

Test material form:

liquid

Details on test material:

Batch/Lot: LT09180058
Purity: 94.3%

In vitro test system

Test system:

human skin model

Remarks:

MatTek EpiDerm

Source species:

human

Cell type:

non-transformed keratinocytes

Vehicle:

unchanged (no vehicle)

Control samples:

yes, concurrent negative control

yes, concurrent positive control

yes, concurrent MTT non-specific colour control

Amount/concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 μL (undiluted)

NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 μL distilled water

POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 μL 8 N KOH solution

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

3 min treatment

Value:

100.2

Negative controls validity:

valid

Positive controls validity:

valid

Results 2

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

60 min treatment

Value:

24.3

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

The mixture of 50 μL test item per 1 mL MTT medium showed reduction of MTT as compared to the solvent. The mixture turned blue/purple.
For quantitative correction of results, the part of absorption due to the non-specific reduction of MTT (NSMTT) was determined by using killed tissues. Therefore, two tissues per treatment period were treated with the test item (KT) or left untreated (KU), respectively. NSMTT was calculated relative to the negative control of living tissues (NC) per treatment period according to the following formula:
NSMTT (3min) = [(ODKT - ODKU)/ODNC] * 100 = [(0.090 - 0.095) / 1.787] *100 = -0.3%
NSMTT (60 min) = [(ODKT - ODKU)/ODNC] * 100 = [(0.071 - 0.102) / 1.689] *100 = -1.8%
NSMTT was ≤ 30% relative to the negative control of living epidermis. In the 3 min experiment NSMTT was -0.3%, in the 60 min experiment -1.8%. This means that the test item was washed away almost completely before the addition of the MTT solution. The true MTT metabolic conversion (TODTT) of the test item treated living tissues (TM) was corrected for each treatment period according to the following formula:
TODTT (3 min) = ODTM - (ODKT - ODKU) = 1.784 – (0.090 - 0.095) = 1.789
TODTT (60 min) = ODTM - (ODKT - ODKU) = 0.379 – (0.071 - 0.102) = 0.410
The mixture of 50 μL test item per 300 μL Aqua dest. and per 90 μL isopropanol showed no colouring as compared to the solvent. Therefore NSC equaled 0%.

Any other information on results incl. tables

See attached file for data tables.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item showed no corrosive effects. The mean relative tissue viability (% negative control) was ≥ 50% (100.2%, NSMTT-corrected) after 3 min treatment and ≥ 15% (24.3%, NSMTT-corrected) after 60 min treatment.