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

Endpoint summary

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

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)

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 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

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

3 min treatment

Value:

100.2

Negative controls validity:

valid

Positive controls validity:

valid

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%.

See attached file for data tables.

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.

Reference 2

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24 October 2017 - 24 November 2017

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

Version / remarks:

28 July 2015

GLP compliance:

yes (incl. QA statement)

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): 30 μL (undiluted)

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

POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 μL 5% SDS solution

Irritation / corrosion parameter:

% tissue viability

Value:

8.2

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

The mixture of 30 μL test item per 1 mL MTT medium showed reduction of MTT compared to the solvent. The mixture turned blue/purple. The coloured test material or MTT reducing substance was classified as “Irritant” i.e. mean tissue viability is < 50%. Therefore, no correction procedures were necessary.

The mixture of 30 μL of the test item per 300 μl aqua dest. and per 300 μL isopropanol showed colouring detectable by unaided eye-assessment. Therefore, the absorption of the chemical in water and isopropanol was measured in the range of 570 ± 30 nm. No absorption was measured in the relevant range.

See attached file for data tables.

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19 July 2017 - 18 October 2017

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)

Version / remarks:

adopted: 26 July 2013

GLP compliance:

yes

Species:

cattle

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 μL

NEGATIVE CONTROL
- Amount(s) applied (volume or weight with unit): 750 μL 0.9% NaCl

POSITIVE CONTROL
- Amount(s) applied (volume or weight with unit): 750 μL 100% EtOH

Duration of treatment / exposure:

10 min.

Duration of post- treatment incubation (in vitro):

2 hours

Number of animals or in vitro replicates:

3

Irritation parameter:

in vitro irritation score

Value:

35.32

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

not determinable because of methodological limitations

See attached file for data tables.

Interpretation of results:

study cannot be used for classification

Conclusions:

The mean in vitro irritation score of 35.32 falls in the range for which no prerdiction of a UN GHSS category can be made.

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Based on the resuls of the BCOP according to OECD TG 437 under GLP, no prediction could be made on eye irritation.

Justification for classification or non-classification

Based on the positive results of an OECD TG 439, 3-Triethoxysilyl-(1,3-dimethylbutylidene)propylamine is classified as Category 2 (irritant) for skin.

Results of an OECD TG 431 did not meet GHS criteria.

Based on the results of an OECD TG 437, no prediction could be made on eye irritation. Considering the positive OECD TG 439 test yielding a Category 2 (irritant) classification for skin as weight of evidence, 3 -Triethoxysilyl-(1,3 -dimethylbutylidene)propylamine is classified for eye irritation (Category 2).