1,1’,1’’-((methylsilanetriyl)tris(oxy))tris(butan-2-amine)

Endpoint summary

Description of key information

Based on the results of a study according to OECD TG 431 the test item is identified as skin corrosive.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

14 June 2019

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: B.40Bis: “In Vitro Skin Corrosion: Human Skin Model Test”

Version / remarks:

30th May 2008

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test system:

artificial membrane barrier model

Source species:

human

Cell type:

non-transformed keratinocytes

Justification for test system used:

The EPISKIN model has been validated for corrosivity testing in an international trial; it is considered to be suitable for this study (STATEMENT ON THE SCIENTIFIC VALIDITY OF THE EPISKINTM TEST (AN IN VITRO TEST FOR SKIN CORROSIVITY); ECVAM JRC Environment Institute, European Commission; Ispra; 03 April 1998).

Vehicle:

unchanged (no vehicle)

Details on test system:

RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiSkin, EPISKIN SNC Lyon, France
- Tissue batch number: 20-EKIN-008

TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature

REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume and number of washing steps: 25 mL PBS 1 x solution
- Observable damage in the tissue due to washing: no

MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 0.3 mg/mL in saline buffer
- Incubation time: 3 hours (± 15 min) at 37±1°C in an incubator with 5±1 % CO2, protected from light, ≥95 % humidified atmosphere.
- Spectrophotometer: Thermo Scientific; Multiscan FC
- Wavelength: 570 nm

FUNCTIONAL MODEL CONDITIONS
- Morphology: Adult human-derived epidermal keratinocytes are seeded on a dermal substitute consisting of a collagen type I matrix coated with type IV collagen. A highly differentiated and stratified epidermis model is obtained after a 13-day culture period comprising the main basal, supra basal, spinous and granular layers and a functional stratum corneum
- Contamination: All biological components of the epidermis and the kit culture medium have been tested for the presence of viruses, bacteria and mycoplasma.

NUMBER OF REPLICATE TISSUES: 2

CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- killed tissues
- Procedure used to prepare the killed tissues: Water-killed epidermis
Place the living epidermis in a 12 well plate with 2 mL of distilled water (replacing the culture medium).Incubate at 37 °C, 5 % CO2, ≥ 95 % humidified atmosphere for 48 hrs +/- 1 hour. At the end of the incubation, discard the water. Keep dead epidermis frozen (dry) in freezer at -15 °C to -30 °C (killed epidermis can be stored and used up to 6 months). Before use, the killed tissues are de-frozen at room temperature (approx. 1 hour in 2 mL of maintenance medium).
- N. of replicates: 2
- Method of calculation used: As indictaed in guideline.

NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 2

PREDICTION MODEL / DECISION CRITERIA
- see table 1

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

TEST MATERIAL
- Amount(s) applied: 50 µL

NEGATIVE CONTROL
- Amount(s) applied: 50 µL
- Concentration: 0.9%

POSITIVE CONTROL
- Amount(s) applied: 50 µL

Duration of treatment / exposure:

exposure times of 4 hours (±10 min), 1 hour (±5 min) and 3 min at room temperature

Number of replicates:

2

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

1st experiment

Remarks on result:

other: results will be presented in an update

Interpretation of results:

Category 1B (corrosive) based on GHS criteria

Conclusions:

Based on the results of the study according to OECD TG 431 the test item can be classified as Corrosive: a combination of optional Subcategories 1B-and-1C.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance is classified as skin corrosion, leading to classification as serious eye damage (Category 1)

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Classification, Labeling, and Packaging Regulation (EC) No 1272/2008

The available data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on this data, the substance is considered to be classified for skin corrosion Cat.1B (H314) and eye damage Cat.1 (H318) under Regulation (EC) No 1272/2008, as amended for the twelfth time in Regulation (EU) 2019/521.