Registration Dossier

Registration Dossier

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Diss Factsheets

Administrative data

Description of key information

Skin irritation/corrosion: not corrosive and not irritating (OECD 431 and 439, GLP)
Eye irritation: not corrosive and not irritating (OECD 437, GLP)
Respiratory irritation: no study available

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2018-06-14 to 2018-09-06
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:
29 July 2016
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: EU Method B.40bis (In Vitro Skin Corrosion: Human Skin Model Test)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Cell source:
other: no data
Justification for test system used:
As recommended by OECD guideline
Vehicle:
unchanged (no vehicle)
Details on test system:
RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™
- Tissue batch number(s): 28629
- Date of initiation of testing: 19 June 2018

TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: not specified
- Temperature of post-treatment incubation (if applicable): 37°C

REMOVAL OF TEST MATERIAL AND CONTROLS
- Observable damage in the tissue due to washing: No


MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3h
- Spectrophotometer: Tecan Sunrise Magellan Version 6.4
- Wavelength: 540 nm

FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: OD (540-570 nm) [1.0 -3.0]: Result: 1.884 ± 0.1525
- Barrier function: ET-50 assay, 100 µL 1% Triton X-100, 4 time-points, n = 3, MTT assay, ET-50 [4.77-8.72 h]: Result: 4.79 h
- Contamination: Longe term antibiotic and antimycotic free culture, No contamination: Result: Sterile

NUMBER OF REPLICATE TISSUES: 2

CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- N. of replicates : 2

PREDICTION MODEL / DECISION CRITERIA
- 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(s) applied (volume or weight with unit): 25 mg moistened with 25 µL deionized water

VEHICLE
- Amount(s) applied (volume or weight with unit): Deionized water 25 µL
- Lot/batch no. (if required): 180958001

NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL deionized water

POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL 8 N KOH
Duration of treatment / exposure:
1st period: 3 min
2 nd period: 60 min
Duration of post-treatment incubation (if applicable):
3 h incubation with MTT
Number of replicates:
2
Irritation / corrosion parameter:
% tissue viability
Remarks:
3 minutes exposure
Run / experiment:
tissue 1
Value:
97.8
Vehicle controls validity:
not examined
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Irritation / corrosion parameter:
% tissue viability
Remarks:
3 minutes exposure
Run / experiment:
tissue 2
Value:
109.8
Vehicle controls validity:
not examined
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Irritation / corrosion parameter:
% tissue viability
Remarks:
60 minutes exposure
Run / experiment:
tissue 1
Value:
93.4
Vehicle controls validity:
not examined
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Irritation / corrosion parameter:
% tissue viability
Remarks:
60 minutes exposure
Run / experiment:
tissue 2
Value:
94.8
Vehicle controls validity:
not examined
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: No
- Colour interference with MTT: No


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
- Range of historical values if different from the ones specified in the test guideline:

Short time incubation – 3 min
Negative control: Mean OD 1.624 (2.5±2.4) Average viability [%] 100 (2.5 ± 2.4), Viability range [%]: 93.7–106.3; % difference 0.14–8.6, unqualified experiments: 0#1
8 N KOH: Mean OD0.126 (8.8±7.4) Average viability [%] 7.6 (8.8 ± 7.4), Viability range [%]: 2.0–15.6; % difference <0.01–23.7, unqualified experiments: 0
Long time incubation – 60 min
Negative control
Mean OD 1.650 (4.0±5.0), Average viability [%] 100 (4.0±5.0), Viability range [%]: 85.6–114.4; % difference 0.13–18.3, unqualified experiments: 0#1
8 N KOH
Mean OD 0.090 (5.7±9.8), Average viability [%] 5.9, Viability range [%]: (5.7 ± 9.8); % difference 2.0–12.6 0.30–38.4, unqualified experiments: 0#2
#1 Unqualified results = if the mean OD of the NC tissues is < 0.8 or > 2.8 if difference in viability for duplicate tissues > 30%
#2 Unqualified results = 8 N KOH: viability > 15% (1-h exposure)

Table 1: Viability after both exposure times

 

Viability 3-minutes exposure

Viability 60-minutes exposure

 

Optical density [OD540] mean tissue 1 and 2 (percent differences)

Mean viability (Difference of Viability) [%]

Optical density [OD540] mean tissue 1 and 2 (percent differences)

Mean viability (Difference of Viability) [%]

Negative control (deionized water)

1.564

100.0

1.606

100.0

 

(2.8)

(2.7)

(0.6)

(0.5)

TA-1

1.62

103.8

1.512

94.1

 

(11.6)

(12.0)

(1.5)

(1.4)

Positive control (8 N KOH)

0.068

4.4

0.070

4.4

 

(11.8)

(0.5)

(0.0)

(0.0)
Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions of the study, the test item tested at two exposure periods of 3 minutes or 1 hour was non-cytotoxic and, hence, predicted to be non-corrosive to skin in an experiment employing an artificial three-dimensional model of human skin. Therefore, the test item does not meet the criteria for classification according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System of Classification and Labelling of Chemicals (GHS), and is thus considered to be not corrosive to the skin.
Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2018-07-26 to 2018-09-19
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:
28 July 2015
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
Version / remarks:
6 July 2012
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Cell source:
other: no data
Justification for test system used:
This test uses the EpiDerm™ reconstructed human epidermis model (MatTek) which consists of normal human epidermal keratinocytes (NHEK) and therefore represents in vitro the target organ of the species of interest and closely mimics the biochemical and physiological properties of the upper parts of the human, i.e. the epidermis.
Vehicle:
unchanged (no vehicle)
Details on test system:
RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™ reconstructed human epidermis model
- Tissue batch number(s): Lot No.: 28641
- Date of initiation of testing: 2018-08-01

TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37°C for 35 min and room temperature for 25 min
- Temperature of post-treatment incubation (if applicable): 37°C

REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: not reported

MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
MTT concentration: 1 mg/mL
- Incubation time: 3 h
- Wavelength: 540 nm

FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: MTT QC assay, 4 h, n = 3; Acceptance criteria: OD (540-570 nm) [1.0 - 3.0], Result (batch: 28641): 2.034 ± 0.077
- Barrier function: ET-50 assay, 100µL 1%Triton X-100, 4 time-points, n = 3, MTT assay; Acceptance criteria: ET-50 [4.77 - 8.72]; Result (batch: 28641): 8.13 h
- Contamination:HIV-1, Hepatitis B, Hepatitis C, Bacteria, yeast, and other fungi: not detected

NUMBER OF REPLICATE TISSUES: 3

CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
Prior to the testing, the test item was evaluated for colour changes. Concurrent negative controls (sterile deionised water) were run in parallel. 25 mg test item were mixed with 300 µL sterile deionised water and incubated in the dark at 37°C, 5% CO 2 and 95% relative humidity for 60 min. At the end of exposure time, the mixture was evaluated of the presence and intensity of the staining. No discolouration of the test item was noted.
In addition, 25 mg test item were mixed with 2 mL isopropanol and incubated at room temperature for three hours. No discolouration of the test item was noted. Hence, the criteria of the test on colour interference were met.
Furthermore, the test item was evaluated for the potential to interfere with the MTT assay reagent (e.g. reduction). A concurrent negative control (sterile deionised water) was run in parallel. 25 mg test item were added to 1 mL MTT solution and incubated at 37°C, 5% CO 2 and 95% relative humidity for 60 min. Untreated MTT solution was used as control. No discolouration of the test item was noted. No additional test had to be performed.


NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 3 tissues were used.

PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be irritating to skin if the viability after exposure is less than or equal to 50%.
- The test substance is considered to be non-irritant to skin if the viability after exposure is greater than 50%.
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 mg of test item moistened with 25 µL Dulbecco’s phosphate buffered saline (DPBS)

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

POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30µL 5% sodium dodecyl sulfate (SDS)
- Concentration (if solution): 5%
Duration of treatment / exposure:
60 min
Duration of post-treatment incubation (if applicable):
42 h
Number of replicates:
3
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
test item, mean value
Value:
100.4
Vehicle controls validity:
not examined
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
positive control, mean value
Value:
5.4
Vehicle controls validity:
not examined
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
positive indication of irritation
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
negative control, mean value
Value:
100
Vehicle controls validity:
not examined
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: No
- Direct-MTT reduction: No
- Colour interference with MTT: No

ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes, the mean OD of the NC is between > 0.8 and < 2.8 (1.505)
- Acceptance criteria met for positive control: Yes , the  mean  viability  of  PC  tissues expressed as % of the negative control tissues is ≤ 20%. (5.4%)
- Acceptance criteria met for variability between replicate measurements: Yes, variation between the replicates was < 18% (6.6%)

Table 1: Summarized Results of in vitro Skin Irritation:

 

Optical density [OD540] mean tissue (n=3)

Mean viability (n=3) [%]

SD (viability %)

DPBS (negative control)

1.505

100.0

5.9

Test item

1.511

100.4

6.6

5% SDS (positive control)

0.081

5.4

0.2
Interpretation of results:
GHS criteria not met
Conclusions:
Under the present test conditions, the test item tested at an exposure time of 60 minutes and a 42-hour post-treatment incubation period, was non-cytotoxic and, hence, predicted to be non-irritant to skin in an experiment employing an artificial three-dimensional model of human skin. Therefore, the test item does not meet the criteria for classification according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System of Classification and Labelling of Chemicals (GHS), and is thus considered to be not irritating to the skin.
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:
2018-06-14 to 2018-09-06
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 i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
Version / remarks:
09 October 2017
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
cattle
Strain:
not specified
Details on test animals or tissues and environmental conditions:
SOURCE OF COLLECTED EYES
- Source: Hubert Bahlmann GmbH & Co. Versandschlachterei Spezialmischfutterwerk KG, 49699 Lindern, Germany
- Number of animals: not specified
- Characteristics of donor animals: 6-12 months old
- Storage, temperature and transport conditions of ocular tissue: To minimise deterioration and bacterial contamination, on collection the eyes were completely submerged in Hanks’ Balanced Salt Solution (HBSS) containing antibiotics.
- Time interval prior to initiating testing: not specified
- indication of any existing defects or lesions in ocular tissue samples: 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.
The quality of each cornea was also evaluated at later steps in the assay. Corneas that had opacity greater than seven opacity units or equivalent for the opacitometer and cornea holders used after an initial one hour equilibration period had to be discarded.
- Indication of any antibiotics used: penicillin at 100 IU/mL and streptomycin at 100 µg/mL
Vehicle:
physiological saline
Controls:
yes, concurrent vehicle
yes, concurrent positive control
Amount / concentration applied:
TEST MATERIAL
- Concentration (if solution): 750 µLof a 20% suspension in 0.9% sodium chloride solution (w/v)

VEHICLE
- Concentration (if solution): 750 µL 0.9% sodium chloride solution
- Lot/batch no. (if required): 180618002; B. Braun Melsungen AG, 34212 Melsungen, Germany
Duration of treatment / exposure:
4 h
Duration of post- treatment incubation (in vitro):
90 ± 5 min
Number of animals or in vitro replicates:
3
Details on study design:
SELECTION AND PREPARATION OF CORNEAE
Bovine eyes from cattle in the age range of 6 to 12 months were obtained from a slaughterhouse, containing penicillin at 100 IU/mL and streptomycin at 100 µg/mL. 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. The quality of each cornea was also evaluated at later steps in the assay. Corneae that had opacity greater than seven opacity units or equivalent for the opacitometer and cornea holders used after an initial one hour equilibration period had to be discarded.
NUMBER OF REPLICATES: 3
NEGATIVE CONTROL USED: 3 corneae incubated with 0.9% sodium chloride solution
POSITIVE CONTROL USED: 3 corneae incubated with 20% imidazole in 0.9% sodium chloride solution
APPLICATION DOSE AND EXPOSURE TIME: each 750 µL were applied for each dosing for 240 min
TREATMENT METHOD: open chamber
POST-INCUBATION PERIOD: yes, for 90 min
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: at least three times
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: opacitometer
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of microtiter plate reader (OD490)
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
After correcting the opacity and mean permeability (OD 490 ) values for background opacity and the negative control permeability OD 490 values, the mean opacity, and permeability OD 490 values for each treatment group were combined in an empirically-derived formula to calculate an in vitro irritancy score (IVIS) for each treatment group as follows:
IVIS = mean opacity value + (15 x mean permeability OD 490 value)
DECISION CRITERIA: As recommended by the guideline.
Irritation parameter:
in vitro irritation score
Run / experiment:
mean of 3 corneae (test group)
Value:
0.629
Vehicle controls validity:
valid
Negative controls validity:
not examined
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Irritation parameter:
in vitro irritation score
Run / experiment:
mean of 3 corneae (negative control)
Value:
0.93
Vehicle controls validity:
valid
Negative controls validity:
not examined
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Irritation parameter:
in vitro irritation score
Run / experiment:
mean of 3 corneae (positive control)
Value:
95.182
Vehicle controls validity:
valid
Negative controls validity:
not examined
Positive controls validity:
valid
Remarks on result:
positive indication of irritation
Other effects / acceptance of results:
OTHER EFFECTS:
- Visible damage on test system: No

ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes, opacity and permeability are below the upper limits for background  opacity  and  permeability  values  for  bovine  corneae  treated  with  the respective negative or solvent/vehicle control.
- Acceptance criteria met for positive control: yes, the positive control gives an IVIS that falls within two standard deviations of the current historical mean.

Table 1: Opacity values

 

Cornea No.

Opacity [Opacity units]

Corrected Opacity

 

 

Mean of group

Standard deviation

0.9% NaCl

1

1.315

0.585

0.585

1.163

2

1.196

3

-0.757

20% Test item

4

0.319

-0.266

0.039

0.271

5

0.717

0.132

6

0.836

0.251

20% Imidazole

7

66.972

66.387

57.702

9.32

8

60.120

59.535

9

47.769

47.184

Table 2: Permeability OD Values (490 nm)

 

Cornea No.

Permeabbility [OD]

Mean of triplicates

Corrected Permeability [OD]

 

per cornea

per group

mean

SD

Mean

SD

0.9% NaCl

1

0.039

0.039

-

0.039

0.001

0.023

0.014

0.038

-

0.039

-

2

0.017

0.016

-

0.016

0.001

0.016

-

0.016

-

3

0.013

0.014

-

0.014

0.001

0.013

-

0.015

-

20% Test item

4

0.137

0.134

0.114

0.111

0.004

0.039

0.063

0.129

0.106

0.135

0.112

5

0.019

0.018

-0.004

-0.005

0.001

0.019

-0.004

0.017

-0.006

6

0.034

0.035

0.011

0.012

0.001

0.035

0.012

0.036

0.013

20% Imidazole

7

2.544

2.557

2.521

2.534

0.057

2.499

0.384

2.508

2.485

2.619

2.596

8

2.946

2.887

2.923

2.864

0.055

2.838

2.815

2.877

2.854

9

2.112

2.121

2.089

2.098

0.013

2.115

2.092

2.136

2.113

Table 3: In vitro irritancy score (IVIS)

 

Cornea No.

Opacity

Permeability

IVIS

per cornea

per group

Mean

SD

0.9% NaCl

1

1.315

0.039

1.900

0.930

1.300

2

1.196

0.016

1.436

3

-0.757

0.014

-0.547

20% Test item

4

-0.266

0.111

1.399

0.629

0.693

5

0.132

-0.005

0.057

6

0.251

0.012

0.431

20% Imidazole

7

66.387

2.534

104.397

95.182

14.345

8

59.535

2.864

102.495

9

47.184

2.098

78.654
Interpretation of results:
GHS criteria not met
Conclusions:
Under the present test conditions, the test item tested in the in vitro BCOP test method, had an IVIS value of 0.629, which is below the cut-off value of 3. Therefore, the test item does not meet the criteria for classification according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System of Classification and Labelling of Chemicals (GHS), and is thus considered to be not a severe irritant or corrosive to the eye.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In vitro skin corrosion

The corrosive properties of of the test item to human skin was assessed in an experiment with an artificial three-dimensional model of human skin according to OECD Guideline 431 and under GLP conditions. The EpiDermTM model was employed.

In comparison to the negative control, the mean viability of cells exposed to the test item was 103.8% after a 3-minute exposure period and 94.1 % after a 1-hour exposure. The 3-minute exposure and the 1 -hour exposure values were above the cut-off percentage cell viability 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.

In vitro skin irritation

The substance was assessed for cytotoxic properties to skin cells, which might lead to irritation of human skin, by using an artificial threedimensional model of human skin in accordance with OECD Guideline 439 and GLP. The EpiDerm™ model was employed.

The mean viability of cells exposed to the test item for 60 min and 42 hours post-treatment incubation was 100.4% of the negative control and, hence, was well above the cut-off percentage cell viability value that distinguishes irritant from non-irritant test items of > 50%. The test item was considered to be non-cytotoxic and predicted to be non-irritant to skin.

In vitro vivo eye corrosion/irritation

The possible potency of the substance of being 'ocular corrosive and severe irritant' was determined employing an in vitro system (Bovine Corneal Opacity and Permeability Assay (BCOP))

according to OECD Guideline 437 and under GLP conditions.

Following treatment with the test item a mean opacity of 0.039 ± 0.271 and a mean permeability value of 0.039 ± 0.063 compared to the negative control were determined. The calculated IVIS of 0.629 ± 0.693 is below the cut-off value of 3. Hence, the test item did not show severely irritant or corrosive properties.

Justification for classification or non-classification

The available data indicate that the substance does not meet the classification criteria for skin corrosion/irritation or eye corrosion/irritation in accordance with Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).

There is no information available on respiratory irritation.