Benzene-1,4-diammonium sulphate

Endpoint summary

Description of key information

Skin irritation

The dermal irritation potential of target chemical Benzene-1,4-diammonium sulphate (CAS No:16245-77-5) was assessedin various in-vitro and in-vivo experimental studies for target chemicalBenzene-1,4-diammonium sulphate (CAS No:16245-77-5) and its structurally similar read across substances.Based on the available data for the target and read across substances and applying the weight of evidence approach, it can be concluded that chemical Benzene-1,4-diammonium sulphate (CAS No:16245-77-5) is unable to cause skin irritation and thus considered as not irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

 

Eye irritation

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the ocular irritation potential of the test chemical Benzene-1,4-diammonium sulphate (CAS No:16245-77-5). Based on the summarized studies for target chemical Benzene-1,4-diammonium sulphate (CAS No:16245-77-5) and its structurally similar read across substances,it can be concluded that the testchemical is able to cause eye irritation and considered as irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Category 2 (irritating to eyes)”.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 5 March 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Data is from experimental study

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

28 July 2015

Deviations:

yes

Remarks:

The living tissues treated with the test item were applied less than 8 mg of test item. As it was noted that all tissues were evenly covered by the test item, this deviation was not considered to comprise the outcome of the study.

Principles of method if other than guideline:

To evaluate the skin irritation potential of the test item Benzene-1,4-diammonium sulphate (CAS No:16245-77-5) /E507469 using the EpiskinTM reconstructed human epidermis model.

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL- Source and lot/batch No.of test material: supplied by the sponsor, batch no. 60810- Expiration date of the lot/batch: 09 November 2018- Purity test date:20 July 2017STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL- Storage condition of test material: At room temperature, protected from humidity- Stability under test conditions:not applicable- Solubility and stability of the test substance in the solvent/vehicle: not applicable- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicableTREATMENT OF TEST MATERIAL PRIOR TO TESTING- Treatment of test material prior to testing: the test item was not treated before testing and was used neat- Preliminary purification step (if any): not applicable- Final dilution of a dissolved solid, stock liquid or gel: not applicable- Final preparation of a solid: no final preparationFORM AS APPLIED IN THE TEST (if different from that of starting material) neat

Test system:

human skin model

Source species:

human

Cell type:

other: Human reconstructed epidermis

Cell source:

other: not applicable

Source strain:

other: not applicable

Justification for test system used:

Based on the peer review of the results of an inter-laboratory study with the EpiskinTM model, the ECVAM Scientific Advisory Committee (ESAC) endorsed the conclusion that the EpiskinTM model can be used for distinguishing between skin irritant and non-irritant chemicals.

Vehicle:

unchanged (no vehicle)

Details on test system:

RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE- Model used: EpiskinTM- Tissue batch number(s):Not specified- Production date: not specified- Shipping date: not specified- Delivery date:not specified- Date of initiation of testing: 5 March 2018TEMPERATURE USED FOR TEST SYSTEM- Temperature used during treatment / exposure: 37°C- Temperature of post-treatment incubation (if applicable): 27°CREMOVAL OF TEST MATERIAL AND CONTROLS-Volume and number of washing steps: At the end of the treatment period, each tissue was removed from the well of the treatment plate, and rinsed with D-PBS. Rinsing was achieved by gently filling and emptying several times each tissue with D PBS to gently remove any residual test or control items.- Observable damage in the tissue due to washing: No damage- Modifications to validated SOP: No modificationsMTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE- MTT concentration: 0.3 mg/mL- Incubation time: 3 hours (±5 minutes) - Spectrophotometer: plate reader- Wavelength: 570 nm- Filter: no filter was used- Filter bandwidth: no filter was used- Linear OD range of spectrophotometer: not specifiedFUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATAhistorical data were not mentioned in the reportNUMBER OF REPLICATE TISSUES: triplicates per condition were used CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE- water-killed tissues- Procedure used to prepare the killed tissues (if applicable): untreated EpiskinTM tissues were placed in a 12 well plate containing 2 mL of water for injections per well. The 12-well plate was placed in an incubator (set at +37°C, 5% CO2) for 48 hours (± 1 hour). At the end of the incubation period, the tissues were dried before being placed in a freezer (-20°C) for at least one night. Once killed, the tissues were stored in the freezer for up to 6 months. Before using, the water-killed tissues were thawed at room temperature (for at least 1 hour ± 5 minutes in 2 mL of maintenance medium).- N. of replicates : triplicates were used- Method of calculation used:-Non-Specific MTT reduction (NSMTT) calculation:-cOD Untreated Killed tissues = ODUK - mean ODblank,-cOD Test Item-treated Killed tissues = ODTIK - mean ODblank.NSMTT = [(mean cODTIK - mean cODUK) / mean cODNC] x 100True MTT metabolic conversion (TODTI):- TODTI = [mean cODTI - (mean cODTIK - mean cODUK)].Then, the relative mean viability is calculated as follows:Relative mean viability = (TODTI / mean cODNC) x 100NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: Two independent sequences : pretest and main test QUANTIFICATION OF IL-1 AlphaThe concentration of the IL-1α in the culture medium retained following the 42-hour recovery period was determined only for test items found with a mean relative viability > 50% after the MTT reduction. For these test items, culture media samples retained from the three negative controls and the three test item-treated tissues were analyzed by ELISA according to our internal procedures. The assay for the determination of IL-1α concentration in EpiskinTM culture medium is an ELISA (Enzyme Linked Immunosorbent Assay) in which anti-IL-1α antibodies are coated in wells of a 96 wells plate. The IL 1α present in the tested samples bind to the immobilised anti-IL-1α antibodies and are revealed using a peroxidase (HRP) conjugated anti-IL-1α antibody.Enzymatic reaction is performed by using a substrate which is transformed into a colored product, which intensity is measured in OD value using a spectrophotometer. The analyte concentration concentrations can be then determined by interpolation from a calibration curve in which OD values are plotted against IL 1α concentrations of calibration standards. PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)- The test substance is considered to be irritant to skin if the viability after 15 minutes exposure and 42 hours post exposure period is less than or equal to 50% or higher than 50M associated with a Il-1 alpha higher than 60 pg/mL- The test substance is considered to be non-corrosive to skin if the viability after 15 minutes exposure and 42 hours post exposure period 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):10 mg ± 2mg- Concentration (if solution): pureVEHICLENo vehicle was usedNEGATIVE CONTROL- Amount(s) applied (volume or weight): 10 µL- Concentration (if solution): neatPOSITIVE CONTROL- Amount(s) applied (volume or weight): 10µL- Concentration (if solution): 5% (w/v)

Duration of treatment / exposure:

15 minutes

Duration of post-treatment incubation (if applicable):

42 hours

Number of replicates:

triplicates

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

Test Item (true MTT metabolic conversion)

Value:

94

Negative controls validity:

valid

Positive controls validity:

valid

Irritation / corrosion parameter:

other: the IL-1α concentrations (pg/mL)

Run / experiment:

Test item

Value:

< 5

Negative controls validity:

valid

Other effects / acceptance of results:

- OTHER EFFECTS:- Visible damage on test system: no damage- Direct-MTT reduction: The MTT solution containing the test item turned blue/purple when compared with the negative control. The test item was therefore considered to have direct MTT reducing properties. As a result, additional controls were performed on water-killed tissues in parallel to the main test.- Colour interference with MTT: During this test, as the water solution containing the test item did not change colour, the test item was found not to have a colouring potential. As a result, no additional controls were used in parallel to the main test.DEMONSTRATION OF TECHNICAL PROFICIENCY: Positive control condition showed proficiency of the test system to quantify tissue viabilityACCEPTANCE 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-

Table 1 :Results

	cOD		Viability(%)		NSMTT
Groupe	Mean	SD	Mean	SD
Negativecontrol	0.738	0.031	100	4
positive control	0.026	0.004	4	1
test item	0.739	0.085	100	12
test item (deadtissues)	0.079	0.013	11	2	6
untreated(deadtissues)	0.036	0.015	5	2
Test item (true MTT metabolic conversion)	0.697		94

cOD=blankcorrectedopticaldensity

MTT = « -(4,5-dimethylthiazol-2-ylà-2,5-diphenyltetrazoliumbromide

NSMTT= nonspecificMTTreduction

SD = standard deviation

Interpretation of results:

GHS criteria not met

Conclusions:

Under the experimental condition of the study, the test item did not induced decrease of tissue viability (94%) and no IL1-alpha release in medium (under 5pg/mL) when applied on EpiskinTM. Hence, , the test item, E507469, is considered to be non-irritant to skin.According to the results of this study, the classification of the test item should be: No Category (UN GHS and Regulation (EC) No. 1272/2008).

Executive summary:

The objective of this study was to evaluate the skin irritation potential of the test item, E507469, using the EpiskinTM reconstructed human epidermis model.

The study design was based upon the international guideline OECD No. 439. The study was conducted in compliance with the principles of Good Laboratory Practice.

Preliminary tests were performed to detect the ability of the test item to directly reduce MTT as well as its colouring potential. Following the preliminary tests, the skin irritation potential of the test item was tested in the main test. The test item and both the negative and positive controls were applied topically on triplicate tissues and incubated at room temperature for 15 minutes. At the end of the treatment period, each tissue was rinsed with D-PBS and incubated for 42 hours at +37°C, 5% CO2 in a humidified incubator. The cell viability was then assessed by means of the colourimetric MTT reduction assay. Relative viability values were calculated for each tissue and expressed as a percentage of the mean viability of the negative control tissues which was set at 100% (as reference viability).

In addition, the concentration of the inflammatory mediator IL-1α was evaluated in the culture medium retained following the 42-hour recovery period. This quantification, based on an ELISA assay, was performed since the mean relative viability of the test item-treated tissues was > 50% following the MTT reduction assay.

In the preliminary tests, the test item was found to have direct MTT reducing properties but no colouring properties. All acceptance criteria for the negative and positive controls were fulfilled. The study was therefore considered to be valid.

Following a 15 minutes exposure and 42 hours of recovery period, the relative mean viability of the tissues treated with the test item was 94%.

As the mean relative viability > 50% after the MTT reduction, the IL-1α concentrations in culture media samples retained from the three negative controls and the three test item-treated tissues were analyzed by ELISA. The IL-1α concentration value of two tissues was found below the limit of quantification (< 5.00 pg/mL). Consequently, the mean IL-1α concentration from the three test item-treated tissues was not calculated. The IL-1α concentration value of the other test item-treated tissue was found < 60 pg/mL (11.2 pg/mL). Therefore, the results met the criteria for an in vitro classification as non-irritant to skin.

Under the experimental conditions of this study, the test item, E507469, is considered to be non-irritant to skin.

According to the results of this study, the classification of the test item should be:      No Category (UN GHS and Regulation (EC) No. 1272/2008).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Remarks:

experimental data of read across substances

Justification for type of information:

Data for the target chemical is summarized based on the structurally similar read across chemicals

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

WoE report is based on 2 eye irritation studies as- WoE-2 and WoE-3. An eye irritation study of test chemical was conducted on rabbits to assess its eye irritating effects.

GLP compliance:

not specified

Specific details on test material used for the study:

- Name of test material (as cited in study report): Benzene-1,4-diammonium sulphate- Molecular formula: C6H8N2.H2O4S- Molecular weight: 206.221 g/mol- Smiles notation: S(=O)(=O)(O)O.c1(ccc(cc1)N)N - InChl : 1S/C6H8N2.H2O4S/c7-5-1-2-6(8)4-3-5;1-5(2,3)4/h1-4H,7-8H2;(H2,1,2,3,4)- Substance type: organic- Physical state: Solid

Species:

rabbit

Strain:

other: 1. albino 2.not specified

Details on test animals or tissues and environmental conditions:

1.TEST ANIMALS- Age at study initiation: Not reported- Weight at study initiation: Not reported- Housing: Not reported- Diet (e.g. ad libitum): Not reported- Water (e.g. ad libitum): Not reported- Acclimation period: Not reportedENVIRONMENTAL CONDITIONS- Temperature (°C): Not reported- Humidity (%): Not reported- Air changes (per hr): Not reported- Photoperiod (hrs dark / hrs light): Not reported2.not specified

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

1.TEST MATERIAL- Amount(s) applied (volume or weight with unit): 10 mg of solid material2. 100mg

Duration of treatment / exposure:

1.Ten mg of solid test material was placed into the right conjunctival sac of each of 2 male albino rabbits. After 20 seconds, 1 treated eye was washed with tap water for 1 minute. The treated eye of the other rabbit was not washed. 2. 24 hours

Observation period (in vivo):

1.Observations of the cornea, iris and conjunctiva were made with an ophthalmoscope at 1 and 4 hours, and at 1, 2, 3, 7 and 14 days; Fluor-i-strip stain and a slit-lamp biomicroscope were used at examinations after the day of treatment.2.24 hours

Number of animals or in vitro replicates:

1.2 albino male rabbits2.Not specified

Details on study design:

1.REMOVAL OF TEST SUBSTANCE- Washing (if done): One treated eye was washed with tap water for 1 minute. The treated eye of the other rabbit was not washed.- Time after start of exposure: 10 mg of solid test material was placed into the right conjunctival sac of each of 2 male albino rabbits. After 20 seconds, 1 treated eye was washed with tap water for 1 minute.TOOL USED TO ASSESS SCORE: Ophthalmoscope at 1 and 4 hours, and at 1, 2, 3, 7 and 14 days; Fluor-i-strip stain and a slit-lamp biomicroscope at examinations after the day of treatment.2.Not specified

Irritation parameter:

other: 1.overall irritation score

Basis:

mean

Time point:

other: 3 days

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Irritation parameter:

other: 2.overall irritation score

Basis:

mean

Time point:

24 h

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

1.Irritation was observed in treated rabbits.2.Moderate irritation observed

1.

Table 1: Ocular Effects
Dose	Treatment	Cornea	Iris	Conjunctiva
10 mg solid test material	Unwashed	A generalized area of slight cloudiness 1-4 hours. A small area of slight cloudiness at 1 day.	Moderate congestion 2-3 days.	Redness: Mild 1 hr.-1day and 3-7 days. Moderate at 2 days. Swelling: Slight at 1 hr. and mild 4 hrs.-1 day. Discharge: Mild 4 hrs.-1 days.
10 mg solid test material	Washed	A generalized area of slight cloudiness 1 hr.-1 day and decreasing to a moderate area of slight cloudiness at 2 days and a small area of slight cloudiness at 3 days.	Moderate congestion 4 hrs.- 3 days.	Redness: Mild 1 hr.-7 days. Swelling: Slight 2-4 hrs. Discharge: None.

 

2. Not specified

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

Based on data the test chemical Benzene-1,4-diammonium sulphate (CAS No:16245-77-5) was considered as irritating to the eyes (GHS Category 2).

Executive summary:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the ocular irritation potential of the test chemical Benzene-1,4-diammonium sulphate (CAS No:16245-77-5). The studies are as mentioned below:

 

An eye irritation test was conducted to evaluate the ocular effects caused by the similar read across chemical according to OECD Guideline 405 (Acute Eye Irritation / Corrosion). About 10 mg aliquot of the test substance produced generalized slight corneal cloudiness, moderate iritis and moderate conjunctivitis in an unwashed rabbit eye. An eye treated and promptly washed had generalized slight corneal cloudiness, moderate iritis and mild conjunctivitis. Both eyes were normal within 14 days after treatment. Since the test material produced moderate ocular effects, it was considered as irritating to the eyes of treated rabbits.

 

The above result was further supported by an eye irritation study conducted for another similar read across chemical on rabbits .100 mg of the test chemical was instilled into the eyes of rabbits and effects were observed for 24 hours. Moderate irritation effects were observed after 24 hours of instillation of the test chemical. Therefore, the test chemical was considered to be moderately irritating to eyes.

 

Based on the above summarized studies for target chemical Benzene-1,4-diammonium sulphate (CAS No:16245-77-5) and its structurally similar read across substances,it can be concluded that the testchemical is able to cause eye irritation and considered as irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Category 2 (irritating to eyes)”.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation:

Various studieshas been investigated for the test chemicalBenzene-1,4-diammonium sulphate (CAS No:16245-77-5)to observe the potential for dermal irritation to a greater or lesser extent. The studies are based on in-vitro and in-vivo experiments conducted for target chemicalBenzene-1,4-diammonium sulphate (CAS No:16245-77-5) and its structurally similar read across substanceswhich have beensummarized as below;

 

The in-vitro skin irritation study of test chemical Benzene-1,4-diammonium sulphate / E507469 (CAS No:16245-77-5) was conducted using the EpiskinTM reconstructed human epidermis model to evaluate the skin irritation potential of the test item. The study design was based upon the international guideline OECD No. 439. The study was conducted in compliance with the principles of Good Laboratory Practice. Preliminary tests were performed to detect the ability of the test item to directly reduce MTT as well as its colouring potential. Following the preliminary tests, the skin irritation potential of the test item was tested in the main test. The test item and both the negative and positive controls were applied topically on triplicate tissues and incubated at room temperature for 15 minutes. At the end of the treatment period, each tissue was rinsed with D-PBS and incubated for 42 hours at +37°C, 5% CO2 in a humidified incubator. The cell viability was then assessed by means of the colourimetric MTT reduction assay. Relative viability values were calculated for each tissue and expressed as a percentage of the mean viability of the negative control tissues which was set at 100% (as reference viability). In addition, the concentration of the inflammatory mediator IL-1α was evaluated in the culture medium retained following the 42-hour recovery period. This quantification, based on an ELISA assay, was performed since the mean relative viability of the test item-treated tissues was > 50% following the MTT reduction assay. In the preliminary tests, the test item was found to have direct MTT reducing properties but no colouring properties. All acceptance criteria for the negative and positive controls were fulfilled. The study was therefore considered to be valid. Following a 15 minutes exposure and 42 hours of recovery period, the relative mean viability of the tissues treated with the test item was 94%. As the mean relative viability > 50% after the MTT reduction, the IL-1α concentrations in culture media samples retained from the three negative controls and the three test item-treated tissues were analyzed by ELISA. The IL-1α concentration value of two tissues was found below the limit of quantification (< 5.00 pg/mL). Consequently, the mean IL-1α concentration from the three test item-treated tissues was not calculated. The IL-1α concentration value of the other test item-treated tissue was found < 60 pg/mL (11.2 pg/mL). Therefore, the results met the criteria for an in vitro classification as non-irritant to skin. Under the experimental conditions of this study, the test item, E507469, is considered to be non-irritant to skin.

 

The above result was supported by the primary irritation study of similar read across chemical conducted on male albino guinea pigs. About 0.05 mL aliquot of a 30% and a 3% solution of the test substance in distilled water were applied to the shaved, intact shoulder skin of 10 male albino guinea pigs. Observations were made at 24- and 48-hours after treatment. The test substance as either a 30% or 3% solution in distilled water caused no irritation at 24 and 48 hours on the shaved, intact skin of guinea pigs.

 

The overall results were further supported by skin irritation study conducted on three male White Vienna rabbits to assess the irritating or corrosive potential of another read across chemical in accordance with OECD guideline (404). About 500mg (0.5g) of chemical was applied on clipped intact skin of upper third of the back or flanks(2.5cm X 2.5cm) of each rabbit. After four hours the patches were removed, and the test site was washed withlutrol and lutrol/water (1 :1). The test sites were examined for erythema and edema at 30 - 60 minutes after removal of the test patches and 24 h, 48 h, 72 h after the beginning of application. No signs of irritation were observed. The mean dermal irritation scores after 4, 24, 48 and 72 hours was 0.0. Hence based on the scores, the test chemical can be considered to be not irritating to White Vienna rabbit skin under the test experimental condition.

 

Based on the available data for the target and read across substances and applying the weight of evidence approach,it can be concluded that thechemical Benzene-1,4-diammonium sulphate (CAS No:16245-77-5) is unable to cause skin irritation and considered as not irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

 

 

Eye irritation

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the ocular irritation potential of the test chemical Benzene-1,4-diammonium sulphate (CAS No:16245-77-5). The studies are as mentioned below:

 

An eye irritation test was conducted to evaluate the ocular effects caused by the similar read across chemical according to OECD Guideline 405 (Acute Eye Irritation / Corrosion). About 10 mg aliquot of the test substance produced generalized slight corneal cloudiness, moderate iritis and moderate conjunctivitis in an unwashed rabbit eye. An eye treated and promptly washed had generalized slight corneal cloudiness, moderate iritis and mild conjunctivitis. Both eyes were normal within 14 days after treatment. Since the test material produced moderate ocular effects, it was considered as irritating to the eyes of treated rabbits.

 

The above result was further supported by an eye irritation study conducted for another similar read across chemical on rabbits .100 mg of the test chemical was instilled into the eyes of rabbits and effects were observed for 24 hours. Moderate irritation effects were observed after 24 hours of instillation of the test chemical. Therefore, the test chemical was considered to be moderately irritating to eyes.

 

Based on the above summarized studies for target chemical Benzene-1,4-diammonium sulphate (CAS No:16245-77-5) and its structurally similar read across substances,it can be concluded that the testchemical is able to cause eye irritation and considered as irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Category 2 (irritating to eyes)”.

Justification for classification or non-classification

The skin and eye irritation potential of test chemical Benzene-1,4-diammonium sulphate (CAS No:16245-77-5)  and its structurally and functionally similar read across substanceswere observed in various studies. The results obtained from these studies indicate that the chemical  is unlikely to cause skin irritation but can cause eye irritation. Hence Benzene-1,4-diammonium sulphate (CAS No:16245-77-5)  can be classified under the category “Not Classified” for skin and “Category 2 (irritating to eyes)” eye as per CLP.