Registration Dossier

Administrative data

Description of key information

Skin irritation/ corrosion (OECD 439 and OECD 431): irritating

Eye irritation (OECD 437): not irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
08 - 29 Aug 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Version / remarks:
(2015)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
Version / remarks:
(Commission Regulation(EC) No 440/2008 of 30 May, 1st ATP 2009)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Hess. Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany
Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Cell source:
other: EpiDerm™ (EPI-200)
Source strain:
not specified
Vehicle:
unchanged (no vehicle)
Details on test system:
RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™ (EPI-200) (MatTek Corporation, Bratislava, Slovakia)
- Tissue batch number: 23351
- Delivery date: 23 Aug 2016
- Date of initiation of testing: 23 Aug 2016

TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 ± 1.5 °C for 35 min in the incubator; thereafter at room temperature for 25 min in a sterile bench

REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume and number of washing steps: Tissues were gently rinsed with DPBS at least 15 times in order to remove any residual test material. After the rinsing the inserts were submerged in DPBS at least 3 times. Afterwards the inserts were once again rinsed with DPBS from the inside and the outside.

MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 h
- Spectrophotometer: microplate reader (Versamax, Molecular Devices, Softmax Pro v.4.7.1)
- Wavelength: 570 nm

FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: The quality of the EpiDerm tissue was assessed by undertaking an MTT cell viability test. The determined OD (540 - 570 nm) was 2.031 ± 0.069 (acceptance criteria: 1.0 - 3.0).
- Barrier function: The barrier function was assessed by determination of the exposure time required to reduce tissue viability by 50% (ET-50) upon application of 100 µL of 1% Triton X-100. The ET-50 value was determined to be 6.77 h (acceptance criteria: 4.77-8.72 h).
- Contamination: The cells used to produce the EpiDerm tissue were screened for the presence of viruses, bacteria, yeast and other fungi.

NUMBER OF REPLICATE TISSUES: 3

CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
Since the test substance showed Color Interference 1h after incubation in deionised water, an additional test with one viable tissue without MTT addition was necessary.
- N. of replicates: One for each untreated and test susbtance treated group
- Method of calculation used: Data were corrected as follows:
OD = ODcoloured tissue (MTT assay) – ODcoloured tissue (no MTT assay)

Since the test substance showed reducing capacity 1 h after MTT incubation, an additional test with freeze-killed tissues had to be performed to determine a correction factor for calculating the true viability in the main test.
- N. of replicates: 2 for each untreated and test susbtance treated group
- Method of calculation used: Data were corrected as follows:
True viability = Viability of treated tissue – Interference from test chemical = ODtvt – ODkt where ODkt = (mean ODtkt – mean ODukt)
tvt = treated viable tissue kt = killed tissues tkt = treated killed tissue ukt = untreated killed tissue (NC treated tissue)


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

PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be irritant to skin if the viability after 1 hour exposure is less or equal than 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% aqueous solution
Duration of treatment / exposure:
60 min
Duration of post-treatment incubation (if applicable):
approx. 43 h
Number of replicates:
triplicates for each treatment and control group
Irritation / corrosion parameter:
% tissue viability
Remarks:
mean of 3 tissues
Run / experiment:
60 min exposure
Value:
6.4
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: viability corrected for color interference and direct MTT reduction of the test substance
Other effects / acceptance of results:
OTHER EFFECTS:
- Direct-MTT reduction: Optical evaluation of the MTT-reducing capacity of the test item after 1 hour incubation with MTT-reagent showed blue colour. An additional test with freeze-killed tissues was performed. The result was used for data correction of the results in the main experiment.
- Colour interference with MTT: The optical pre-experiment (colour interference pre-experiment) to investigate the test item’s colour change potential in water led to a colour change of water. An additional test with one viable tissue was performed to gain the correction factor for calculation of the true viability.

ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: After treatment with the negative control the absorbance values (1.745, 1.842, 1.717) were in the range of the required acceptability criterion of mean OD ≥ 0.8 and ≤ 2.8 for the 60 min treatment.
- Acceptance criteria met for positive control: Exposure to the positive control induced a decrease in the relative absorbance as compared to the negative control to 3.2% thus confirming the validity of the test system.
- Acceptance criteria met for variability between replicate measurements: The relative standard deviations of the 3 identical replicates of the test substance, the positive and negative control, were < 18% (1.3, 1.8, 3.7%), thus ensuring the validity of the study.

Table 2. Results after treatment with the test substance and controls

 

 

Absorbance at 570 nm *

 

 

Mean absorbance of 3 tissues

Rel. absorbance (%) **

Rel. SD (%)

Rel. absorbance (% of negative control)***

Mean absorbance blank corrected viable tissue without MTT

Mean absorbance blank corrected freeze-killed tissue minus mean absorbance blank corrected freeze-killed negative control tissue

Mean rel. absorbance (% of negative control) after complete correction procedure

Tissue 1

Tissue 2

Tissue 3

Tissue 1

Tissue 2

Tissue 3

Negative control

1.745

1.842

1.717

1.768

98.7

104.2

97.1

3.7

100.0

 

Positive control

0.055

0.057

0.056

0.056

3.1

3.2

3.2

1.8

3.2

 

Test substance

0.116

0.117

0.114

0.116

6.6

6.6

6.4

1.3

6.5

0.003

0.074

6.4

Additional test with one viable tissue without MTT addition

Negative Control

0.001

 

100.0

 

Test substance

0.003

 

218.9

 

Additional test with two freeze-killed tissues

Negative Control

0.064

0.049

 

0.056

 

100.0

 

Test substance

0.125

0.135

 

0.130

 

230.7

 

* Mean of 3 replicate wells after blank correction

** Relative absorbance per tissue (rounded values): 100 × (absorbance tissue) / (mean absorbance negative control)

*** Relative absorbance per treatment group (rounded values): 100 × (mean absorbance test item/positive control) / (mean absorbance negative control)

Interpretation of results:
other: Skin Irrit. 2 or Skin Corr. 1 according to Regulation (EC) No 1272/2008
Conclusions:
Under conditions of the reconstructed human epidermis test, a tissue viability of 6.4% was determined (threshold for classification ≤ 50%). Therefore, the test substance is considred to possess an irritant potential to the skin.
Executive summary:

The skin irritation potential of the test substance was determined by an in vitro skin irritation test using a reconstructed human skin model according to OECD Guideline 439 and in compliance with GLP (2017). After treatment with the test substance for 60 min the tissue viability decreased to 6.4% compared to the negative control (threshold for irritancy ≤ 50%). Therefore, the test substance is considered to possess an irritant potential.

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
27 Sep - 04 Nov 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
Version / remarks:
(Updated Guideline adopted 29 July 2016)
Deviations:
no
Qualifier:
according to
Guideline:
other: EU B.40 bis (In Vitro Skin Corrosion: Human Skin Model Test)
Version / remarks:
(Commission Regulation (EC) No 440/2008 of 30 May 2008)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Hess. Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany
Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Cell source:
other: EpiDerm™ (EPI-200)
Source strain:
not specified
Vehicle:
unchanged (no vehicle)
Details on test system:
RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™(EPI-200) (MatTek Corporation, Bratislava, Slovakia)
- Tissue batch number: 23372
- Delivery date: 01 Nov 2016

TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature (3 ± 0.5 min exposure); 37 ± 1.5 °C (60 ± 5 min exposure)

REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: Tissues were gently rinsed with DPBS 20 times in order to remove any residual test material.

MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 h
- Spectrophotometer: microplate reader (Versamax, Molecular Devices, SoftMax Pro Enterprise v. 4.7.1)
- Wavelength: 570 nm
- Filter: without reference filter

FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: The quality of the EpiDerm tissue was assessed by undertaking an MTT cell viability test. The determined OD (540 - 570 nm) was 1.587 ± 0.089 (acceptance criteria: 1.0 - 3.0).
- Barrier function: The barrier function was assessed by determination of the exposure time required to reduce tissue viability by 50% (ET-50) upon application of 100 µL of 1% Triton X-100. The ET-50 value was determined to be 6.25 h (acceptance criteria: 4.77-8.72 h).
- Contamination: The cells used to produce the EpiDerm tissue were screened for the presence of viruses, bacteria, yeast and other fungi.

NUMBER OF REPLICATE TISSUES: 2

CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
Since the test substance showed reducing capacity 1 h after MTT incubation, an additional test with freeze-killed tissues had to be performed to determine a correction factor for calculating the true viability in the main test.
- Number of replicates: 2 for each untreated and test substance treated group
- Method of calculation used: Data were corrected as follows:
True viability = Viability of treated tissue – Interference from test chemical = ODtvt – ODkt where ODkt = (mean ODtkt – mean ODukt)
tvt = treated viable tissue kt = killed tissues tkt = treated killed tissue ukt = untreated killed tissue (NC treated tissue)

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

PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be non-corrosive to skin if the viability after 3 minutes exposure is greater than 50% and the viability after 1 hour exposure is greater than 15%.
- 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%.
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
Duration of treatment / exposure:
3 ± 0.5 min and 60 ± 5 min
Number of replicates:
duplicates for each treatment and control group
Irritation / corrosion parameter:
% tissue viability
Remarks:
mean value of 2 tissues
Run / experiment:
3 min exposure
Value:
120.1
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: viability corrected for direct MTT-reduction of test substance
Irritation / corrosion parameter:
% tissue viability
Remarks:
mean value of 2 tissues
Run / experiment:
60 min exposure
Value:
111.9
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: viability corrected for direct MTT-reduction of test substance
Other effects / acceptance of results:
OTHER EFFECTS:
- Direct-MTT reduction: Since the test substance showed reducing capacity 1 hour after MTT incubation, an additional test with freezekilled tissues was performed to determine a correction factor for calculating the true viability in the main test.
- Colour interference with MTT: The test substance did not change colour, when mixed with deionised water and thus passed the colour interference pre-test.

ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The mean OD of the tissue replicates treated with the negative control is ≥ 0.8 and ≤ 2.8 for every exposure time (range: 1.586 to 1.814).

- Acceptance criteria met for positive control: The mean viability of the tissue replicates treated with the positive control for 1 hour, is <15% compared to the negative control (5.3%).

- Acceptance criteria met for variability between replicate measurements: The Coefficient of Variation (CV) in the range 20 – 100% viability between tissue replicates is ≤ 30% (range: 4.1% to 16.8%).

Table 2. Results after 3 and 60 min treatment with the test substance and controls

 

 

Exposure interval (min)

Mean absorbance at 570 nm of 3 wells (blank corrected)

Mean absorbance of 2 tissues

Rel. absorbance (% of negative control) *

CV (%)

Corrected absorbance of test substance **

Corrected Rel. absorbance (% of negative control)***

Tissue 1

Tissue 2

Tissue 1

Tissue 2

Negative control

 

 

 

 

 

 

3

1.554

1.684

1.619

96.0

104.0

5.7

 

100.0

Positive control

0.373

0.395

0.384

23.0

24.4

4.1

 

23.7

Test substance

1.888

1.998

1.943

116.6

123.4

4.0

1.945

120.1

Negative control (freeze killed tissue)

0.127

0.100

0.114

111.9

88.1

16.8

 

100.0

Test substance (freeze killed)

0.107

0.117

0.112

94.1

102.3

5.9

 

98.2

 

 

Negative control

 

 

 

 

 

 

60

1.624

1.709

1.666

97.5

102.5

3.6

 

100.0

Positive control

0.078

0.099

0.088

4.7

5.9

16.1

 

5.3

Test substance

2.191

2.234

2.213

131.5

134.1

1.4

1.865

111.9

Negative control (freeze killed tissue)

0.105

0.096

0.100

104.8

95.2

6.8

 

100.0

Test substance (freeze killed)

0.354

0.542

0.448

352.4

539.3

29.6

 

445.8

* Relative absorbance per tissue (rounded values): 100 × (mean absorbance test substance/positive control) / (mean absorbance negative control)

** Corrected absorbance test substance: absorbance test substance – (absorbance test item freeze-killed – absorbance negative control freeze-killed)

*** Corrected Relative viability (%): 100 x [mean absorbance test substance – (absorbance test substance freeze-killed – absorbance negative control freeze-killed) / (mean absorbance negative control)]

Interpretation of results:
other: non-corrosive according to Regulation (EC) No 1272/2008
Conclusions:
Under the conditions of the reconstructed human epidermis test the test substance does not possess corrosive properties.
Executive summary:

The skin corrosion potential of the test substance was assessed by an in vitro skin corrosion test using a human skin model according to OECD Guideline 431 and in compliance with GLP (2017). After treatment with the test substance the mean relative absorbance value did not decrease (3 min exposure: 120.1%; 1 h exposure: 111.9%) compared to the negative control. Therefore, the test substance is not considered be corrosive to the skin.

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:
05 Aug 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
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:
(July 2013)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Hess. Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany
Species:
cattle
Strain:
not specified
Details on test animals or tissues and environmental conditions:
SOURCE OF COLLECTED EYES
- Source: Schlachthof Aschaffenburg, Aschaffenburg, Germany
- Characteristics of donor animals: at least 9 month old
- Storage, temperature and transport conditions of ocular tissue: The isolated eyes were transported to the laboratory in Hanks´ Balanced Salt Solution (HBSS) at ambient temperature.
- Time interval prior to initiating testing: The corneae were isolated on the same day after delivery of the eyes and were directly used in the BCOP test.
- Indication of any existing defects or lesions in ocular tissue samples: All eyes were carefully examined macroscopically for defects. Those presenting defects such as vascularization, pigmentation, opacity and scratches were discarded.
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.75 mL

POSITIVE CONTROL
- Amount applied: 0.75 mL

NEGATIVE CONTROL
- Amount applied: 0.75 mL
Duration of treatment / exposure:
10 min
Duration of post- treatment incubation (in vitro):
2 h
Number of animals or in vitro replicates:
triplicates for each treatment and control group
Details on study design:
SELECTION AND PREPARATION OF CORNEAS:
The cornea was carefully removed from the eye using scalpel and rounded scissors. A rim of about 2 mm of tissue (sclera) was left for stability and handling of the isolated cornea. Each isolated cornea was mounted in a specially designed cornea holder.

QUALITY CHECK OF THE ISOLATED CORNEAS:
At the end of the equilibration period, the basal opacity was determined (t0). Each cornea with a value of a basal opacity > 7 was discarded.

TREATMENT METHOD:
The cornea holder consists of anterior and posterior compartments, which interface with the epithelial and endothelial sides of the cornea, respectively. The endothelial side of the cornea was positioned against the sealing ring (O-ring) of the posterior part of the holder. The cornea was gently flattened over the O-ring but stretching was avoided. The anterior part of the holder was positioned on the top of the cornea and fixed in place with screws. Both compartments of the holder were filled with incubation medium. The posterior compartment was filled first to return the cornea to its natural convex position. After equilibration for about 1 hour, the anterior compartment received the test substance or the controls on the surface of the corneae. The corneae were incubated in a horizontal position at 32 ± 1 °C in the water-bath for 10 minutes.

POST-INCUBATION PERIOD: no

REMOVAL OF TEST SUBSTANCE:
The test substance was rinsed off from the application side with saline.

- POST-EXPOSURE INCUBATION: 2 h in a vertical position

METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: Corneal opacity was determined by the amount of light transmission through the cornea via an opacitometer (OP_KiT opacitometer, Electro Design, France).
- Corneal permeability: The passage of sodium fluorescein dye was measured with the aid of a microplate reader (Versamax Molecular Devices) at 490 nm (OD490).

SCORING SYSTEM: In Vitro Irritancy Score (IVIS), IVIS = opacity value + (15 x OD490 value)

DECISION CRITERIA:
Test substance with an IVIS > 55 was regarded as serious eye damage and labelled Category 1 according to CLP/EHS/GHS.
Test substance with an IVIS ≤ 3 was regarded as non-irritant and labelled in no category.
Test substance with an IVIS > 3; ≤ 55: no prediction can be made.
Irritation parameter:
in vitro irritation score
Remarks:
mean value of 3 corneae
Run / experiment:
10 min incubation
Value:
1.02
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
With the negative control (saline) neither an increase of opacity nor permeability of the corneae could be observed (mean IVIS = 0.80). The positive control (2-ethoxyethanol) was tested undiluted and showed clear opacity and distinctive permeability of the corneae (mean IVIS = 100.50) corresponding to a classification as serious eye damaging (CLP/EPA/GHS (Cat 1)).

ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The negative control resulted in opacity and permeability values that were less than the established upper limits for background opacity and permeability values for bovine corneae treated with the respective negative control.
- Acceptance criteria met for positive control: The positive control resulted in an IVIS which was within two standard deviations of the current historical mean.

Table 2. Results after 10 min incubation time.

Test group

Opacity value = Difference (t130-t0) of Opacity

Permeability at 490 nm (OD490)

IVIS

Mean IVIS

 

 

Mean

 

Mean

Negative Control

0

0.00

0.060

0.053

0.90

0.80

0

0.050

0.75

0

0.050

0.75

Positive Control

90.0*

0.993*

104.89

100.50

83.00*

1.351*

103.26

79.00*

0.956*

93.34

Test substance

1.00*

-0.001*

0.98

1.02

0.00*

0.001*

0.01

2.00*

0.004*

2.06

*corrected values

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
Under conditions of the Bovine Corneal Opacity and Permeability Test (BCOP) the test subtance was not irritating to the eye. Application of the test substance to bovine corneae resulted in a calculated mean IVIS of 1.02.
Executive summary:

The eye irritation potential of the test substance was determined by a bovine corneal opacity and permeability (BCOP) test according to OECD Guideline 437 and in compliance with GLP (2016). Application of the test substance to bovine corneae resulted in a calculated mean IVIS of 1.02. Thus, the test substance is not considered to be irritant to the eye.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin

The skin irritation potential of the test substance was determined by an in vitro skin irritation test using a reconstructed human skin model according to OECD Guideline 439 and in compliance with GLP (2017). After treatment with the test substance for 60 min the tissue viability decreased to 6.4% compared to the negative control (threshold for irritancy ≤ 50%). Therefore, the test substance is considered to possess an irritant potential.

In a next step, the skin corrosion potential of the test substance was assessed by an in vitro skin corrosion test using a human skin model according to OECD Guideline 431 and in compliance with GLP (2017). After treatment with the test substance the mean relative absorbance value did not decrease (3 min exposure: 120.1%; 1 h exposure: 111.9%) compared to the negative control. Therefore, the test substance is not considered be corrosive to the skin.

In conclusion, based on available studies, the test substance is considered to be irritating to the skin and therefore is classified as Skin Irrit. 2, H315 according to CLP.

Eye

The eye irritation potential of the test substance was determined by a bovine corneal opacity and permeability (BCOP) test according to OECD Guideline 437 and in compliance with GLP (2016). Application of the test substance to bovine corneae resulted in a calculated mean IVIS of 1.02. Thus, the test substance is not considered to be irritant to the eye.

Justification for classification or non-classification

The available data on skin irritation meet the criteria for classification as Skin Irrit. Cat. 2 (H315) according to Regulation (EC) 1272/2008.

The available data on eye irritation do not met criteria for classification according to Regulation (EC) 1272/2008 and are therefore conclusive but not sufficient for classification.