1-Ethyl-3-methylimidazolium benzoate

Endpoint summary

Description of key information

Skin:

In an in vitro GLP-skin corrosion study according to OECD Guideline 431, the test substance showed no skin corrosive properties in an reconstructed human epidermis model (BASF SE, 2012).

In an in vitro GLP-skin irritation study according to OECD Guideline 439, the test substance showed no skin irritating properties in an reconstructed human epidermis (RhE) model (BASF SE, 2012).

Eye:

In an ex vivo GLP- eye irritation study according to OECD Guideline 437, an IVIS score of 71.0 was determined in the BCOP-model (BASF SE, 2012).

In an in vitro GLP- eye irritation study according to OECD Guideline 437, a cell viability of 9 % was determined in an reconstructed human corneal epidermis (RhCE) model (BASF SE, 2012).

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:

weight of evidence

Study period:

2012-07-24 to 2012-09-05

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2004-04-13

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Batch No.of test material: 10361/11/203

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Justification for test system used:

Based on the results of ECVAM (European Center for Validation of Alternative Methods) funded validation studies, it was concluded by the ECVAM Scientific Advisory Committee that the EpiDerm™ human epidermis model is suitable to be used for distinguishing between corrosive and non-corrosive chemicals (ECVAM: ESAC statement on the application of the EpidermTM human skin model for skin corrosivity testing of 14-15 Mar 2000) as well as between irritant and non-irritant chemicals (ECVAM: ESAC statement on the scientific validity of in-vitro tests for skin irritation testing of 5 Nov 2008).

Vehicle:

unchanged (no vehicle)

Details on test system:

RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: Epi-200, MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia

TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during exposure: 37 °C / room temperature
- Temperature of post-treatment incubation: 37 °C

REMOVAL OF TEST MATERIAL AND CONTROLS
- Washing steps: with PBS, 3 min or 1 h after start of exposure and after incubation.
- Observable damage in the tissue due to washing: No

MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1.0 mg / mL
- Incubation time: 55 - 65 min
- Spectrophotometer: SunriseTM Absorbance Reader
- Wavelength: 570 nm without reference filter

NUMBER OF REPLICATE TISSUES: 2

NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1

PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is less than 50 %, or if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15 %.
- The test substance is considered to be non-corrosive to skin if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is greater than or equal to 15 %.

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

TEST MATERIAL
- Amount applied: 50 µL

NEGATIVE CONTROL
- Amount applied: 50 µL

POSITIVE CONTROL
- Amount applied: 50 µL
- Concentration: 8-n potassium hydroxide solution

Duration of treatment / exposure:

3 min or 1 h

Duration of post-treatment incubation (if applicable):

3 h

Number of replicates:

2

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

3 min exposure

Value:

107

Negative controls validity:

valid

Positive controls validity:

valid

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

1 h exposure

Value:

45

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes
- Acceptance criteria met for variability between replicate measurements: The value for inter-tissue variability of the test substance for the exposure period of 1 hour is about 0.34 and therefore out of the acceptance range. Since all other quality criteria of the test were met and the viability values of both tissues are well above the cut off for skin corrosion, this deviation is not considered to adversely affect the result of this study.

		Exposure: 3 min			Exposure: 1 hour
Test substance		Tissue 1	Tissue 2	Mean	Tissue 1	Tissue 2	Mean
NC	Mean OD570	2.109	2.079	2.094	2.113	2.154	2.134
	Viability [% of NC]	100.7	99.3	100	99.0	101.0	100
Test substance	Mean OD570	2.239	2.249	2.244	1.124	0.785	0.954
	Viability [% of NC]	106.9	107.4	107	52.7	36.8	45
PC	Mean OD570	0.486	0.382	0.434	0.047	0.038	0.042
	Viability [% of NC]	23.2	18.3	21	2.2	1.8	2

Interpretation of results:

GHS criteria not met

Reference 2

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

2012-07-24 to 2012-09-05

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2010-07-22

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Batch No.of test material: 10361/11/203

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Justification for test system used:

Based on the results of ECVAM (European Center for Validation of Alternative Methods) funded validation studies, it was concluded by the ECVAM Scientific Advisory Committee that the EpiDerm™ human epidermis model is suitable to be used for distinguishing between corrosive and non-corrosive chemicals (ECVAM: ESAC statement on the application of the EpidermTM human skin model for skin corrosivity testing of 14-15 Mar 2000) as well as between irritant and non-irritant chemicals (ECVAM: ESAC statement on the scientific validity of in-vitro tests for skin irritation testing of 5 Nov 2008).

Vehicle:

unchanged (no vehicle)

Details on test system:

RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: Epi-200, MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia

TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during exposure: 25 min at room temperature followed by 35 min at 37 °C in the incubator.
- Temperature of post-treatment incubation: 37 °C

REMOVAL OF TEST MATERIAL AND CONTROLS
- washing steps: PBS, 1 hour after start of application.
- Observable damage in the tissue due to washing: No

MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1.0 mg/mL
- Incubation time: 55 - 65 min
- Spectrophotometer: SunriseTM Absorbance Reader
- Wavelength: 570 nm without reference filter

NUMBER OF REPLICATE TISSUES: 3

NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1

PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- A test substance is considered as "irritant", if the mean relative tissue viability with a test substance is less than or equal to 50 %.

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

TEST MATERIAL
- Amount applied: 30 µL

NEGATIVE CONTROL
- Amount applied: 30 µL

POSITIVE CONTROL
- Amount applied: 30 µL
- Concentration: 5 % (w/v)

Duration of treatment / exposure:

1 h

Duration of post-treatment incubation (if applicable):

24 ± 2 h

Number of replicates:

3

Irritation / corrosion parameter:

% tissue viability

Value:

62

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes
- Acceptance criteria met for variability between replicate measurements: Yes

Test substance		Tissue 1	Tissue 2	Tissue 3	Mean	SD
NC	Mean OD570	2.401	2.172	2.443	2.339
	Viability [% of NC]	102.7	92.9	104.5	100	6.25
Test substance	Mean OD570	1.313	1.819	1.210	1.447
	Viability [% of NC]	56.1	77.8	51.7	62	13.94
PC	Mean OD570	0.203	0.427	0.348	0.326
	Viability [% of NC]	8.7	18.3	14.9	14	4.87

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

2012-07-09 to 2012-09-05

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)

Version / remarks:

2015-07-28, pre-Guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

2002-04-24

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Batch No.of test material: 150999-33-0

Species:

human

Details on test animals or tissues and environmental conditions:

- Description of the cell system used:
The EpiOcular™ model (OCL-200) is a three-dimensional non-keratinized tissue construct composed of normal human derived epidermal keratinozytes used to model the human corneal epithelium. The EpiOcular™ tissues (surface 0.6 cm²) are cultured on specially prepared cell culture inserts (MILLICELLs®, 10 mm diameter) and are commercially available as kits (EpiOcular™ 200), containing 24 tissues on shipping agarose.

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 50 µL

Duration of treatment / exposure:

30 min

Duration of post- treatment incubation (in vitro):

2 h

Number of animals or in vitro replicates:

2

Details on study design:

- Details of the test procedure used:
Basic procedure: Two tissues were treated with the test substance, the PC and NC, respectively. Due to the physical condition of the test substance the protocol for liquids was applied.
Pre-incubation of the tissues: On the day of arrival in the laboratory, the tissues were transferred to sterile 6-well plates with 1 mL assay medium and preconditioned in the incubator at standard culture conditions for 16 - 24 hours (pre-incubation).
Pretreatment of the tissues: After the pre-incubation the tissues were pre-treated with 20 µL of PBS in order to wet the tissue surface. The tissues were incubated at standard culture conditions for 30 minutes.
Application of the test substance: Using a pipette, fifty microliter (50 µL) of the undiluted liquid test substance was applied covering the whole tissue surface. Control tissues were concurrently applied with 50 µL of sterile de-ionized water (NC) or with 50 µL of methyl acetate (PC). After application, the tissues were placed into the incubator until the total exposure time of 30 minutes was completed.
Removal of the test substance and postincubation period: To remove the test substance, the tissues were washed with sterile PBS. For this purpose the tissues were immersed and swiveled three times in each of three beakers filled with PBS. Washed tissues were immediately immersed into 12-well plates, pre-filled with 5 mL/well pre-warmed medium (post-soak immersion) in order to remove residual test substance. After 12 minutes of post-soak immersion, each tissue was dried on absorbent paper and transferred to fresh 6-well plates filled with 1 mL/well pre-warmed medium. Subsequently, the tissues were incubated at standard culture conditions for 2 hours (postincubation period).

- RhCE tissue construct used: OCL-200, MatTek Corp., Ashland MA, USA
- Doses of test chemical and control substances used: 50 µL
- Duration and temperature of exposure, post-exposure immersion and post-exposure incubation periods: 30 min at ~37 °C exposure, 12 min at ~37 °C post-exposure immersion, 2 h at ~37 °C post-exposure incubation

- Number of tissue replicates used per test chemical and controls: 2
- Wavelength used for quantifying MTT formazan, and linearity range of measuring device: The optical density at a wavelength of 570 nm (OD570) of the extracts was determined spectrophotometrically.
- Description of the method used to quantify MTT formazan: After the post-incubation period, the assay medium was replaced by 0.3 mL MTT solution and the tissues were incubated in the incubator for 3 hours. After incubation, the tissues were washed with PBS to stop the MTT-incubation. The formazan that was metabolically produced by the tissues was extracted by incubation of the tissues in isopropanol at room temperature overnight or for at least 2 hours on a plate shaker. The optical density at a wavelength of 570 nm (OD570) of the extracts was determined spectrophotometrically. Blank values were established of 4 microtiter wells filled with isopropanol for each microtiter plate.

- Description of evaluation criteria used including the justification for the selection of the cut-off point for the prediction model:
In case one of the below given acceptance criteria is not covered, repetition of the test was considered.
Assay acceptance criterion for the NC:
The absolute OD570 of the NC-tissues in the MTT-test is an indicator of tissue viability obtained in the testing laboratory after the shipping and storing procedure and under specific conditions of the assay. Tissue viability is acceptable if the mean OD570 of the NC is > 1.0. The mean OD570 of the NC should not exceed 2.5.
Acceptance criteria for the PC: Methyl acetate used as PC usually leads to a tissue viability of approx. 25 %. A viability of < 50 % is acceptable.
Assay acceptance criterion for tissue variability: Two tissues were treated under the same conditions. A variability between the tissues is considered to be acceptable if the difference of the viability is < 20 %.

- Reference to historical positive and negative control results demonstrating suitable run acceptance criteria
- Reference to historical data of the RhCE tissue construct

- Positive and negative control means and acceptance ranges based on historical data
- Acceptable variability between tissue replicates for positive and negative controls ≤ 20 %
- Acceptable variability between tissue replicates for the test chemica:l ≤ 20 %

Irritation parameter:

other: cell viability [%]

Value:

9

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

OTHER EFFECTS:
- Visible damage on test system: No

ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes

Test substance		Tissue 1	Tissue 2	Mean	Inter-tissue variability [%]
NC	mean OD570	1.750	1.681	1.716
	viability [% of NC]	102.0	98.0	100	4.0
12/0365-1	mean OD570	0.153	0.161	0.157
	viability [% of NC]	8.9	9.4	9	0.4
PC	mean OD570	0.424	0.441	0.433
	viability [% of NC]	24.7	25.7	25	1.0

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Reference 2

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

2012-07-13 to 2012-09-05

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2009-09-07

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

2002-04-24

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Batch No.of test material: 10361/11/203

Species:

cattle

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Schlachthof Bensheim, Am Schlachthof 7 - 9, 64625 Bensheim
- Age at study initiation: > 12 months, < 60 months

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 750 µL

Duration of treatment / exposure:

10 min

Duration of post- treatment incubation (in vitro):

2 h

Number of animals or in vitro replicates:

3

Details on study design:

SELECTION AND PREPARATION OF CORNEAS
Corneas free of defects (opacity, scratches, pigmentation etc.) were dissected with a 2 to 3 mm rim of sclera. Isolated corneas were mounted in specially designed corneal holders that consists of anterior and posterior chambers. Both chambers were filled to excess with pre-warmed Eagles's MEM (without phenol red) and then equilibrated in a vertical position at about 32 °C for at least 1 hour.
After the equilibration period the medium in both chambers was replaced with fresh pre-warmed medium and initial corneal opacity readings were taken for each cornea with an opacitometer. Any corneas that show macroscopic tissue damage or an opacity value < 512 opacity units were discarded. Corneas with opacity values close to the median value of all corneas were selected as negative control (NC). The remaining corneas were then distributed into treatment and positive control groups.

QUALITY CHECK OF THE ISOLATED CORNEAS
According to OECD TG 437 corneas that have an opacity value >7 are to be discarded. In the opacitometer BASF-OP2.0 in combination with the used cornea holder set, the maximal initial opacity of >7 arises from I= 512 lux with Io= 597 lux.

NUMBER OF REPLICATES
3

NEGATIVE CONTROL USED
Yes, de-ionized water

POSITIVE CONTROL USED
Yes, sodium hydroxide 1% (w/v) solution in de-ionized water

APPLICATION DOSE AND EXPOSURE TIME
750 µL, 10 min

TREATMENT METHOD: closed chamber

POST-INCUBATION PERIOD: no

REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: The NC and PC were then removed from the anterior chamber using a syringe and the epithelium was washed at least 3 times with Eagle's MEM (containing phenol red) and once with Eagle's MEM (without phenol red). Both chambers were then refilled with fresh Eagle's MEM (without phenol red). The epithelium was rinsed with the open chamber method since the test substance could not be removed using a syringe.

- POST-EXPOSURE INCUBATION: 2 h at ~ 32 °C

METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: Final corneal opacity readings were taken for each cornea with an opacitometer.
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of microtiter plate reader (OD490)
- Others: Before measurement, each cornea was observed visually and observations were recorded.

SCORING SYSTEM: In Vitro Irritancy Score (IVIS)

DECISION CRITERIA: the decision criteria as indicated in the TG was used.

Irritation parameter:

cornea opacity score

Value:

38

Negative controls validity:

valid

Positive controls validity:

valid

Irritation parameter:

fluorescein retention score

Value:

2.198

Negative controls validity:

valid

Positive controls validity:

valid

Irritation parameter:

in vitro irritation score

Value:

71

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

OTHER EFFECTS:
- Visible damage on test system: No

ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin:

The objective was to determine a possible skin irritating/corrosive potential of the test substance by in vitro studies. A single in vitro assay may not always be sufficient, using the currently available methods, to cover the full range of skin irritating/corrosive potential. Consequently, the following in vitro assays were performed:

In an in vitro dermal corrosion study according to OECD Guideline 431 (2012), 50 µL undiluted 1H-imidazolium, 3-ethyl-1-methyl-, benzoate was applied to a reconstructed human epidermis tissue (EpiDerm™) for 3 min or 1 h, respectively followed by a 3 h post treatment incubation. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the test substance treated epidermal tissues is compared to that of negative control tissues. The ratio of the values indicates the relative tissue viability. The test substance was not able to reduce MTT directly. The acceptance criteria for positive (8N potassium hydroxide solution) and negative (de-ionized water) control were fulfilled. Mean tissue viability of 2 replicates after 3 min incubation was 107.0 % and after 1 h incubation 45 % compared to the negative control.

The result does not meet the GHS criteria for a classification as skin corrosive.

To determine the skin irritating potential of 1H-imidazolium, 3-ethyl-1-methyl-, benzoate, an in vitro dermal irritation study according to OECD Guideline 439 was conducted (2012). 30 µL undiluted 1H-imidazolium, 3-ethyl-1-methyl-, benzoate was applied to a reconstructed human epidermis tissue (EpiDerm™) for 1 h. After 24 h post treatment incubation, the tissue viability was determined by MTT-test (see above). The acceptance criteria for positive (5 % (w/v) sodium dodecyl sulfate) and negative (de-ionized water) control were fulfilled. Mean tissue viability of 3 replicates after 1 h incubation was 62 % compared to the negative control. The result does not meet the GHS criteria for a classification as skin irritating.

In conclusion, 1H-imidazolium, 3-ethyl-1-methyl-, benzoate does not meet the GHS classification criteria for skin corrosion or skin irritation.

 

 

Eye:

The objective was to determine a possible eye irritating potential of the test substance by in vitro studies. A single in vitro assay may not always be sufficient, using the currently available methods, to cover the full range of eye irritating potential. Consequently, two in vitro assays were performed. 

BCOP

The potential of the test substance to cause ocular irritation or serious damage to the eyes was assessed in 2012 by a single topical application of 750 μL of undiluted 1H-imidazolium, 3-ethyl-1-methyl-, benzoate to the epithelial surface of isolated bovine corneas according to OECD guideline 437. Three corneas were treated with the test-substance for an exposure period of 10 min. In addition to the test substance, a negative control (NC; de-ionized water) and a positive control (PC; Sodium hydroxide 1 % (w/v) solution in de-ionized water) were applied to three corneas each and showed the expected results. Corneal opacity was measured quantitatively as the amount of light transmitted through the cornea (mean opacity value = 38.0). Permeability was measured quantitatively as the amount of sodium fluorescein dye that passes across the full thickness of the cornea (mean permeability value = 2.198). Both measurements were used to calculate an In Vitro Irritancy Score (IVIS) of the test substance: 71.0, indicating the potential for serious eye damage.  

EpiOcular

The potential of the test substance to cause ocular irritation was assessed in 2012 by a single topical application of 50 μL of the undiluted test substance to a reconstructed three dimensional human cornea model (EpiOcular™) according to OECD guideline 492. Two EpiOcular™ tissue samples were incubated with the test substance for 30 min followed by a 2-hours post-incubation period. Tissue destruction was determined by an MTT-test. The EpiOcular™ eye irritation test showed the following results:

The test substance is not able to reduce MTT directly. The mean viability of the test-substance treated tissues was 9.0 %, indicating irritant potential.

 

Based on the results for BCOP and EpiOcular Test and considering the evaluation criteria, the test substance shows serious eye damaging potential in the in vitro eye irritation test strategy under the test conditions chosen.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008.

Serious eye damaging but no skin irritating properties were documented. As a result the substance should be classified as serious eye damaging (category 1, H318) under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.