Alkane-alpha,omega-diyl bis{[(triethoxysilyl)propyl]carbamate}_E2

Endpoint summary

Description of key information

In the in vitro study according to OECD 431 the test item tested at two exposure periods of 3 minutes or 1 hour was non-corrosive to skin in an experiment employing an artificial three-dimensional model of human skin (LPT, 2015). The test item tested at an exposure time of 60 minutes and a 42-hour post-treatment incubation period in an in-vitro skin irritation study according to OECD 439, was

non-cytotoxic and, hence, non-irritant to skin in an experiment employing an artificial three-dimensional model of human skin (LPT, 2015).

Under the present conditions of the in-vitro eye irritation study according to OECD 437, the test item had an IVIS value of -0.362, which is below the cut-off value of 3 (UN GHS no category) (LPT, 2015).

Test item does neither induce serious eye damage nor serious eye irritation in this in vitro test system.

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:

2015-01-23 to 2015-02-05

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)

Version / remarks:

July 26, 2013 reconstructed human epidermis (RHE) test method

GLP compliance:

yes (incl. QA statement)

Test system:

human skin model

Source species:

human

Species:

other: in vitro

Details on test animals or test system and environmental conditions:

The following Reconstructed Human Epidermis Model was used:
EpiDermTM (EPI-200-SCT, Lot no. 19622) MatTek In Vitro Life Science Laboratories, s.r.o, Mlynské Nivy 73, 821 05 Bratislava II, Slovak Republic.

Vehicle:

water

Remarks:

sterile deionised water

Amount / concentration applied:

- test item: 50 μL of test item were applied to the skin model with a surface area of 0.63 cm2.
- Positive control item was 8 N KOH4, 50 µl
- Negative control was sterile deionised water, 50µl

Duration of treatment / exposure:

3 minutes and 1 hour

Details on study design:

Cell viability measurements
- MTT (3-[4,5-Dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide, Thiazolyl blue; CAS number 298-93-1) reduction, which had been shown to give accurate and reproducible results, was used to measure cell viability
- Each skin sample was placed in an MTT assay solution of 1 mg/mL (37°C incubation temperature, 5% CO2, 95% humidity) for 3 hours
- The precipitated blue formazan product was extracted using the solvent propanol-27, and the concentration of the formazan was measured by
determining the optical density (OD) at a wavelength of 570 nm in a spectrophotometer
- Cell viability measurements were carried out at the end of the exposure period (1st period: 3 min; 2nd period: 60 min). The measurements were
made for each of the two tissues in triplicate.
- Previous checks for interference of the test item with the MTT assay or the tissues were performed. No discoloration or test item
interference with the vital dye was noted

ADMINISTRATION
- EpiDerm tissues were conditioned by pre-incubation (1 hour) for release of transport stress related compounds and debris in the incubator
(37°C, 5% CO2, 95% humidity)
- After pre-incubation tissues were transferred to fresh Maintenance Medium and topically exposed with test item and controls
- 50 μL of test item were applied to the skin model with a surface area of 0.63 cm2 to uniformly cover the skin surface
- Positive control item was 8 N KOH4, 50 µl
- Negative control was sterile deionised water, 50µl
- Two tissues were used per treatment, negative and positive control and exposition time (18 Tissues in total)
- At the end of the exposure period, tissues were rinsed (with Dulbecco's phosphate buffered saline (D-PBS)), blotted and assay medium is
replaced by MTT assay medium (final concentration: 1 mg MTT (3-[4,5-Dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide,
Thiazolyl blue)/mL medium).
- After 3-h incubation, tissues were washed with Dulbecco's phosphate buffered saline (D-PBS), blotted and the blue formazan salt was extracted
with Isopropanol
- Optical density of the formazan extract was determined spectrophotometrically at 570 nm and cell viability was calculated for each tissue as
% of the mean of the negative control tissues
- Skin corrosivity potential of the test materials was classified according to the remaining cell viability obtained after 3 minutes or 1 hour exposure
with the test chemical

Irritation / corrosion parameter:

other: cut-off percentage cell viability value

Run / experiment:

The EpiDerm™ model was employed, 3 minute exposure

Value:

87.5

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: Under the present test conditions test item tested at two exposure periods of 3 minutes (cell viability value =87.5 %) or 1 hour (cell viability value =91.8 %) was non-corrosive to skin.

Irritation / corrosion parameter:

other: cut-off percentage cell viability value

Run / experiment:

The EpiDerm™ model was employed, 1 hour exposure

Value:

91.8

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: Under the present test conditions test item tested at two exposure periods of 3 minutes (cell viability value =87.5 %) or 1 hour (cell viability value =91.8 %) was non-corrosive to skin.

Assay acceptability criteria

Assay acceptance criterion 1: Negative control

The absolute OD of the negative control (NC) tissues (treated withsterile deionised water) in the MTT test is an indicator of tissue viability obtained in the testing laboratory after shipping and storing procedures and under specific conditions of use.

The assay meets the acceptance criterion if the mean OD₅₄₀of the NC tissues is ≥ 0.8 and ≤ 2.8.

Assay acceptance criterion 2: Positive control

A8N KOHwas used as positive control (PC) and tested concurrently with the test chemicals. Concurrent means here the PC has to be tested in each assay.

Tissues treated with the PC, should reflect the ability of the tissues to respond to a corrosive chemical under the conditions of the test method (viability after 1hour exposure: < 15%).

Assay acceptance criterion 3:variability between tissue replicates

Associated and appropriate measures of variability between tissue replicatesshould not exceed 30% (in the range of 20 – 100% viability).

Interpretation of results

The mean OD values obtained for the test item and the positive control were used to calculate percentage viability relative to the negative control, which is arbitrarily set at 100%. The cut-off percentage cell viability value distinguishing corrosive from non-corrosive test items was used to evaluate the results and identify corrosive materials and shown to be appropriate. The prediction of corrosivity associated with theEpiDerm^TMmodel is:

The test item is considered to be corrosive to skin:

If the viability after 3 minutes exposure was < 50%, or
if the viability after 3 minutes exposure was ≥ 50% and the viability after 1hour exposure was < 15%.

The test item is considered to be non-corrosive to skin:

If the viability after 3 minutes exposure was ≥ 50% and the viability after 1hour exposure was ≥ 15%.

Conclusions:

Under the present test conditions the test item tested at two exposure periods of 3 minutes or 1 hour was non-corrosive to skin in an experiment employing an artificial three-dimensional model of human skin.

Executive summary:

The purpose of this study was to assess the corrosive properties of the test item to human skin, in anexperiment with an artificial three-dimensionalmodel of human skin.

TheEpiDerm^TMmodel was employed.

Two tissues were used for each treatment and concurrent control groups. The optical density (OD) was determined byusing the MTT (3-[4,5-Dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide, Thiazolyl blue) reduction assayand expressed as relative percentage of viability of the negative control-treated tissues.

50 µL test item were applied topically to the model skin surface. Sterile deionised water was used as the negative control. 8N KOH

was used as the positive reference item.The test item and the reference items were applied to the skin model surface at two exposure periods of 3 minutes or 1 hour.

In comparison to the negative controls, the mean viability of cells exposed to the test item was 87.5% after a 3-minute exposure period and 91.8% after a 1‑hour exposure.

The 3-minute and the1-hour exposure values were above the cut-off percentage cellviability values distinguishing corrosive from non-corrosive test items of >50% and >15%, respectively.

Therefore, the test item was non-corrosive in this skin model and is predicted to be non-corrosive to human skin.

The mean optical density (OD) of the negative control of 2 tissues was 1.815 (3‑minute exposure) or 1.827 (1-hour exposure) and

was well within the acceptable range of ≥ 0.8 to ≤ 2.8. The viability of cells treated with the positive reference item 8N KOH were 2.0% (3-minute exposure) and 1.9% (1-hour exposure) of the negative control and, hence well below the 15% cut-off value at the

1-h exposure. The standard deviation of all replicates determined (at 20 - 100% viability) was below the limit of acceptance of 30%. Hence, all acceptance criteria were fulfilled.

Conclusion

Under the present test conditions the test item tested at two exposure periods of 3 minutes or 1 hour was non-corrosive to skin in an experiment employing an artificial three-dimensional model of human skin.

Reference 2

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2015-03-26 to 2015-04-17

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Qualifier:

according to guideline

Guideline:

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

Qualifier:

according to guideline

Guideline:

EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)

Version / remarks:

Commission Regulation (EC) No. 761/2009, method B.46. In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test, adopted August 24, 2009.

GLP compliance:

yes (incl. QA statement)

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Species:

other: in vitro

Details on test animals or test system and environmental conditions:

The following Reconstructed Human Epidermis Model was used:
EpiDermTM (EPI-212, Lot no. 21654) MatTek In Vitro Life Science Laboratories, s.r.o, Mlynské Nivy 73, 821 05 Bratislava II, Slovak Republic.

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

30 µl test item was applied topically to the model skin surface. Dulbecco’s phosphate buffered saline (D-PBS) was used as the negative
control. 5% aqueous sodium dodecyl sulphate (SDS) was used as the positive reference item.

Duration of treatment / exposure:

60 minutes

Details on study design:

TEST FOR INTERFERENCE OF TEST ITEM WITH MTT REDUCTION ASSAY
- Prior to the testing, the test item was evaluated of colour changes under aqueous conditions. Therefore, 30 µL test item was diluted in
300 µL deionized water and incubated at 37°C, 5% CO2 and 95% relative humidity (RH) for 60 minutes. At the end of exposure time, the mixture was evaluated of the presence and intensity of the staining. No discolorations were noted.
- Furthermore the test item was evaluated for its potential to interfere with the MTT assay reagent (e.g. reduction). Therefore, 30 µL test item was
dissolved in 1 mL MTT solution and incubated at 37°C, 5% CO2 and 95% relative humidity (RH) for 60 minutes. Untreated MTT solution was used as
control. No change of colour was noted.
Hence, no possible interacting with the MTT measurement had to be considered and no additional test had to be performed.

ADMINISTRATION
- 30 µL of test item were applied to the skin model with a surface area of 0.63 cm2 to uniformly cover the skin surface
- Three replicate tissues were employed
- At the end of the exposure period, the test item was carefully washed from the skin surface with Dulbecco's phosphate buffered saline (D-PBS)
- The whole exposure period for the used EpiDermTM skin model was 60 minutes
- The incubation conditions were 37°C, 5% CO2 and 95% humidity for 35 minutes and 25 minutes at room temperature
- Concurrent negative and positive controls were used, each in triplicate, to demonstrate that viability (NC), barrier function and resulting issue
sensitivity (PC) of the tissues are within a defined historical acceptance range
- Positive control item was 5% aqueous sodium dodecyl sulphate (SDS)
- Negative control was D-PBS5
- 30 μL of negative and positive controls were used

- Viability measurements were not performed immediately after the exposure to the test item, but after a post-treatment incubation period of the
rinsed tissues in fresh medium of 42 hours
- This period allows both for recovery from weakly irritant effects and for appearance of clear cytotoxic effects
- Each skin sample was placed in an MTT solution of 1 mg/mL (37°C incubation temperature, 5% CO2, 95% humidity) for 3 hours
- The precipitated blue formazan product was extracted using the solvent propanol-2
- Concentration of the formazan was measured by determining the optical density (OD) at a wavelength of 570 nm in a spectrophotometer
(Tecan Sunrise Magellan Version 6.4)
- Measurements were made for each of the three tissues in duplicate

Irritation / corrosion parameter:

other: cut-off percentage cell viability

Run / experiment:

The test method is based on reconstructed human epidermis models.

Value:

92.4

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: The test item tested at an exposure time of 60 min and a 42-h post-treatment incubation period, was non-cytotoxic and, hence, non-irritant to skin in an experiment employing an artificial three-dimensional model of human skin

Assay acceptability criteria

Assay acceptance criterion 1: Negative control

The absolute OD of the negative control (NC) tissues (treated with sterile PBS buffer) in the MTT test is an indicator of tissue viability obtained in the testing laboratory after shipping and storing procedures and under specific conditions of use.

The assay meets the acceptance criterion if the mean OD570 of the NC tissues is ≥ 1.0 and ≤ 2.5.

Assay acceptance criterion 2: Positive control

A 5% SDS (in H2O) solution was used as positive control (PC) and tested concurrently with the test chemicals. Concurrent means here the PC has to be tested in each assay, but not more than one PC is required per testing day.

The assay meets the acceptance criterion if the mean viability of PC tissues expressed as % of the negative control tissues is ≤ 20%.

Assay acceptance criterion 3: Standard deviation

Since in each test skin irritancy potential is predicted from the mean viability determined on 3 single tissues, the variability of tissue replicates should be acceptably low.

The assay meets the acceptance criterion if the standard deviation (SD) calculated from individual % tissue viabilities of the 3 identically treated replicates is < 18%

Interpretation of results

The OD values obtained for each test sample were used to calculate mean percentage viability relative to the negative control, which is arbitrarily set at 100%. The cut-off mean percentage cell viability value that distinguishes irritant from non-classified test substances is given below:

The test item has to be considered to be irritant to skin in accordance with UN GHS category 2, if the tissue viability after exposure and post-treatment incubation is below or equal 50%.

The test item has to be non-irritant if the tissue viability after exposure and post-treatment incubation is higher than 50%.

Conclusions:

Under the present test conditions, test item tested at an exposure time of 60 minutes and a 42-hour post-treatment incubation period, was
non-cytotoxic and, hence, non-irritant to skin in an experiment employing an artificial three-dimensional model of human skin. Hence, the test item
did not show irritant properties and is therefore not classified as irritant (UN GHS no category).

Executive summary:

The purpose of this study was to determine cytotoxic properties of the test item to skin cells, which might lead to irritation of human skin, by using an artificial three-dimensionalmodel of human skin. TheEpiDerm^TMmodel was employed.

Three tissues were used for each treatment and concurrent control groups. The optical density (OD) was determined byusing the MTT (3-[4,5-Dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide, Thiazolyl blue) reduction assayand expressed as relative percentage of viability of the negative control-treated tissues.

The undiluted test item was applied topically to the model skin surface. Dulbecco’s phosphate buffered saline (D-PBS)was used as the negative control.5% aqueous sodium dodecyl sulphate (SDS) was used as the positive reference item.

The mean viability of cells exposed to test item was 92.4% of the negative controls and, hence, was well above the cut-off percentage cell viability value that distinguishes irritant from non-irritant test items of >50%. Test item was considered to be non-cytotoxic and predicted to be non-irritant to skin.

The mean optical density (OD) of the negative control of 3 tissues was 2.346 and was well within the acceptable range of ≥ 1.0 to ≤ 2.5.Theviability of cells treated with thepositive reference item, 5% SDS,was 3.1% of the negative control and fulfilled the acceptance criterion of < 20%. The standard deviation of all triplicates determined was below the limit of acceptance of 18%.Hence, all acceptance criteria were fulfilled.

 

Conclusion

Under the present test conditions, test item tested at an exposure time of 60 minutes and a 42-hour post-treatment incubation period, was non-cytotoxic and, hence, non-irritant to skin in anexperiment employing an artificial three-dimensional model of human skin. Hence,the test item did not show irritant properties and is therefore not classified as irritant (UN GHS no category).

 

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not 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:

2015-01-23 to 2015-02-12

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)

Version / remarks:

Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage, adopted July 26, 2013

Qualifier:

according to guideline

Guideline:

EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)

Version / remarks:

EC Guidelines Council Regulation (EC) No. 1152/2010 method B.47 “Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants“ (published in the Official Journal of the European Union L324, December 09, 2010

GLP compliance:

yes (incl. QA statement)

Species:

other: Bovine eyes from cattle in the age range of 6 to 12 months

Details on test animals or tissues and environmental conditions:

Bovine eyes from cattle in the age range of 6 to 12 months were obtained from a slaughterhouse1. To minimize deterioration and bacterial
contamination, on collection the eyes were completely submerged in Hanks’ Balanced Salt Solution2 (HBSS) containing 1% Penicillin/Streptomycin3.
Upon arrival at the laboratory, the eyes were examined for defects such as but not limited to increased opacity, scratches, and neovascularisation.
Only corneas from eyes free of defects were used.

Vehicle:

unchanged (no vehicle)

Controls:

other: Positive control item: 1% NaOH solution in aqua ad iniectabilia, Solvent control item: 0.9% sodium chloride solution

Amount / concentration applied:

750 µl test item was used as supplied.
750 µl solvent control item, 0.9% sodium chloride solution
750 µl positive control item, 1% NaOH solution in aqua ad iniectabilia

Duration of treatment / exposure:

Exposure period: 10 minutes

Observation period (in vivo):

After rinsing the corneas were incubated at 32°C ± 1°C for two hours. After this post incubation period, the corneas were examined.

Number of animals or in vitro replicates:

Three corneas were used for each treatment group (test item, solvent control and positive control).

Details on study design:

PREPARATION OF BOVINE EYES
- Corneas were dissected with a 2 to 3 mm rim of sclera and mounted in corneal holders with anterior (epithelium) and posterior (endothelium)
chambers
- The chambers were filled to excess with pre-warmed Eagle’s Minimum Essential Medium (EMEM)
- Corneal holder was equilibrated at 32±1°C for at least one hour
- After equilibration period, fresh pre-warmed EMEM was added to both chambers
- Baseline opacity readings were taken for each cornea. Corneas exhibiting macroscopic tissue damage (e.g. scratches, pigmentation,
neovascularisation) or an opacity >7 opacity units were discarded
- Mean opacity of all equilibrated corneas was calculated by use of an opacitometer
- A minimum of three corneas with opacity values close to the median value for all corneas were selected as solvent control corneas
- The remaining corneas were then distributed into treatment, negative and positive control groups
ADMINISTRATION
- Three corneas were used for each treatment group
Solvent control item: 0.9% sodium chloride solution
Positive control item: 1% NaOH solution in aqua ad iniectabilia
Test item: test item was used as supplied
- Exposure period: 10 minutes
- After exposure period of 10 minutes the test item, solvent control and positive control, were removed from each chamber and epithelium was
washed with EMEM at least three times
- As the test item was highly viscous and not soluble in EMEM, the epithelium was washed additionally with 50% dimethylsulfoxide (DMSO) in aqua
ad iniectabilia
- Subsequently, the epithelium was washed with EMEM containing phenol red at least three times in order to detect pH-changes of the medium
caused by residues of the test item or control items
- Washing was repeated until no test item or discolouration (yellow or purple) of phenol red was visible
- Corneas were rinsed a final time with EMEM only to remove any remaining phenol red from the chamber
- Chamber was then filled with EMEM without phenol red
- After rinsing the corneas were incubated at 32°C ± 1°C for two hours. After this post incubation period, the corneas were examined
EXAMINATION
- Corneal injury was assessed by evaluating the opacity and permeability of the cornea
- Corneal opacity was determined by the amount of light transmission through the cornea measured quantitatively with the aid of an opacitometer
resulting in opacity values measured on a continuous scale
- To determine the corneal permeability 1 mL sodium fluorescein solution (5 mg/mL in 0.9% sodium chloride solution) was added to the anterior
chamber (epithelial surface) while the posterior chamber (endothelial surface) was refilled with fresh EMEM
- The holder was incubated in a horizontal position at 32±1°C for 90±5 minutes
- Amount of sodium fluorescein that crossed from the anterior to the posterior chamber was measured quantitatively using a microplate reader
(Tecan Sunrise Magellan Version 6.412).
- Measurements at 490 nm were recorded as optical density (OD490). The fluorescein permeability values were determined using OD490 values
based upon a visible light spectrophotometer using a standard 1 cm path length

Irritation parameter:

in vitro irritation score

Run / experiment:

BCOP test

Value:

< 0

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Conclusions:

Under the present test conditions the test item, tested in the in vitro BCOP test method, had an IVIS value of -0.362, which is below the cut-off value
of 3 (UN GHS no category). Test item does neither induce serious eye damage nor serious eye irritation in this in vitro test system. Therefore, no
classification concerning hazard class “serious eye damage/eye irritation” is necessary.

Executive summary:

The purpose of this study was to determinea possible potency of the test item of being 'ocular corrosive and severe irritant' employing an in vitro system.The Bovine Corneal Opacity and Permeability Assay (BCOP) test method is an organotypic model that provides short-term maintenance of normal physiological and biochemical function of the bovine cornea in vitro.In this test method, possible damage by the test item was assessed by quantitative measurements of changes in corneal opacity and permeability inisolated corneas from bovine eyes.

Corneal opacity was measured quantitatively as the amount of light transmission through the cornea. Permeability was measured quantitatively as the amount of sodium fluorescein dye that passes across the full thickness of the cornea, as detected in the medium in the posterior chamber.The measurements were used to calculate an in vitro irritancy score (IVIS), which was used to assign an in vitro irritancy hazard classification category for prediction of the in vivo ocular irritation potential of the test item.

Three corneas were used for each treatment group (test item, solvent control and positive control). The liquid test item was used undiluted as recommended in the test guideline 437.0.9% NaCl solution was used as the solvent control and 1% NaOH in aqua ad iniectabilia as the positive control item.

The test item and the controls were applied to the epithelial surface of the cornea by addition to the anterior chamber of the corneal holder. The exposure time for the test item and the controls was10 minutes. The optical density (OD) was measured at a wavelength of 490 nm.

The acceptance criteria of validity were fulfilled in this test.

Following treatment with test item a meanopacity and a mean permeability value of <0.01 compared to the solvent control were

determined. An IVIS of -0.362 was calculated. The calculated IVIS was below the cut-off value of 3 (UN GHS no category). Hence, the test item does neither induce serious eye damage nor serious eye irritation in this in vitro test system. Therefore, no classification concerning hazard class “serious eye damage/eye irritation” is necessary.

 

 

Conclusion

Under the present test conditions test item, tested in the in vitro BCOP test method, had an IVIS value of-0.362,which is below the cut-off value of 3 (UN GHS no category).Test item does neither induce serious eye damage nor serious eye irritation in this in vitro test system. Therefore, no classification concerning hazard class “serious eye damage/eye irritation” is necessary.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the assessment of three in vitro studies (skin corrosion / skin irritation and eye irritation) and according to criteria of EC Regulation 1272/2008 the test item is not irritating to skin and eye and therefore must not be classified.