4,4'-thiodiethylene hydrogen -2-octadecenylsuccinate

Endpoint summary

Description of key information

Skin Irritation

Two in vitro skin irritation studies are available for the Substance and are summarised as follows:

 

OECD 431 (in vitro corrosion: RHE):              Non corrosive

OECD 439 (In vitro skin irritation: RHE):        Non irritant

Based on the weight of evidence the data indicates that the data indicates that the test material should not be classified as a skin irritant.

 

Eye Irritation

An in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study was available. The in vivo data was conducted in 1981 before the amendment of the REACH annex for the considerations of non-animals data first.

One in vivo eye irritation studies is available for the Substance. The study is summarised as follows:

 

OECD 405 (in vivo Rabbit):                              Irritant

 

The data indicates that the test material should be classified as an eye irritant.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

7th August 2014 - 17th September 2014

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)

GLP compliance:

yes

Specific details on test material used for the study:

Lot Number 00031-353/ E00298-234-001
Physical State: Brown Solid
Sotrage Conditions: Ambient Temerpature in the dark, sealed container

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Cell source:

other: MatTek

Justification for test system used:

The EpiDerm™ model closely mimics the human epidermis and thus provides an important in vitro approach in the evaluation of dermal corrosion and toxicity.

Vehicle:

water

Details on test system:

The 3-dimensional Human Dermal Epithelial Model (EpiDerm™, MatTek Corp., Ashland, MA) is made up of normal human keratinocytes in serum free medium. The cells form an epithelial tissue that consists of organized basal, spinous, granular, and cornified layers analogous to those found in vivo. The EpiDerm™ model also contains epidermis-specific differentiation markers such as profilaggrin, the K1/K10 cytokeratin pair, involucrin, and type I epidermal transglutaminase, as well as keratohyalin granules, tonofilament bundles, desmosomes, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns characteristic of in vivo epidermis. This model has been used with several common tests of cytotoxicity, corrosion and irritation including 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT), release of lactate dehydrogenase (LDH), expression and release of interleukin 1-alpha (IL-1a), release of prostaglandin E2 (PGE2) and sodium fluorescein permeability. A growing body of evidence indicates that EpiDerm™ effectively provides a non-animal means to assess dermal corrosion and other toxicological issues.

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

25 mg of test article

Duration of treatment / exposure:

3 minutes at room temperature and 60 minutes at approximately 37°C, approximately 5% CO2 in a humidified incubator.

Duration of post-treatment incubation (if applicable):

The MTT assay was performed by transferring the tissues to 24- well plates containing 300 µL MTT medium (1.0 mg/mL). After 3 hours MTT incubation at approximately 37°C, approximately 5% CO2 in a humidified incubator, the tissues were rinsed
twice with DPBS. The blue formazan salt was extracted by submerging tissues in 2 mL isopropanol in a 24-well plate. The extraction time was overnight protected from light, followed by a 15 minute shaking period the following day.

Number of replicates:

n=6

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

3 Minute Mean

Value:

ca. 107.9

Negative controls validity:

valid

Remarks:

100

Positive controls validity:

valid

Remarks:

30.6

Remarks on result:

no indication of irritation

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

60 minute Mean

Value:

ca. 81.2

Negative controls validity:

valid

Remarks:

100

Positive controls validity:

valid

Remarks:

5.7

Remarks on result:

no indication of irritation

Other effects / acceptance of results:

Negative Control (NC)
The assay meets the acceptance criterion if the Optical Density (OD570) of the NC tissues (treated with sterile ultrapure water) in the MTT assay is =0.8 and =2.8. This is an indicator of tissue viability following shipping and conditions under use. In this assay, the acceptance
criterion was met with each negative control OD between 1.870 and 2.798.

Positive Control (PC)
8N KOH (potassium hydroxide) was used as a PC and tested concurrently with the test article. The assay is meeting the acceptance criteria if the mean viability of the positive control after 1 hour exposure, expressed as mean % of the negative control, is <15%. In this
assay, this acceptance criterion was met with mean % viability of 5.7% viable after 1 hour exposure, resulting in the classification as a corrosive.

Tested Samples
The assay is meeting the acceptance criteria if the tested samples, when in the range of 20 - 100% viability, the Coefficient of Variation (CV) between tissue replicates is =30%. This is an indicator of tissue reproducibility and proper performance of the assay. In this assay, this
acceptance criterion was met with a percent CV of 7.7% and 7.8% for the 3 minute and 1 hour exposures, respectively.

Interpretation of results:

GHS criteria not met

Conclusions:

Substance was demonstrated to be non-corrosive in vitro corrosion assay.

Executive summary:

The MatTek EpiDerm™ model was used to assess the potential dermal corrosivity of a test article by determining the cell viability of the tissues after exposure to the test article. The pre-testing (color and MTT pre-test) was performed on August 20, 2014 while the dosing and MTT assay were performed on August 26th. The objective of this study was to assess the dermal corrosion potential of the test article. Tissues were exposed to the test article and controls for three minutes and one hour. The viability of each tissue was determined by MTT assay. The positive control, 8N potassium hydroxide (KOH), reduced cell viability to 30.6% of control after 3 minute exposure and to 5.7 of control after 1 hour exposure. The test article had no effect on the cell viability after 3 minutes exposure (>100% viable) and only a mild effect at 60 minutes exposure (>81% viable). These data suggest that the test material is non-corrosive according to the OECD test guideline using MatTek EpiDerm™ tissues.

Reference 2

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24th September 2014 - 28th October 2014

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)

GLP compliance:

yes

Specific details on test material used for the study:

Lot Number 00031-353/ E00298-234-001
Physical State: Brown Solid
Sotrage Conditions: Ambient Temerpature in the dark, sealed container

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Cell source:

other: MatTek

Justification for test system used:

The EpiDerm™ model closely mimics the human epidermis and thus provides an important in vitro approach in the evaluation of dermal corrosion and toxicity.

Vehicle:

water

Details on test system:

The 3-dimensional Human Dermal Epithelial Model (EpiDerm™, MatTek Corp., Ashland, MA) is made up of normal human keratinocytes in serum free medium. The cells form an epithelial tissue that consists of organized basal, spinous, granular, and cornified layers analogous to those found in vivo. The EpiDerm™ model also contains epidermis-specific differentiation markers such as profilaggrin, the K1/K10 cytokeratin pair, involucrin, and type I epidermal transglutaminase, as well as keratohyalin granules, tonofilament bundles, desmosomes, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns characteristic of in vivo epidermis. This model has been used with several common tests of cytotoxicity, corrosion and irritation including 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT), release of lactate dehydrogenase (LDH), expression and release of interleukin 1-alpha (IL-1a), release of prostaglandin E2 (PGE2) and sodium fluorescein permeability. A growing body of evidence indicates that EpiDerm™ effectively provides a non-animal means to assess dermal corrosion and other toxicological issues.

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

25 mg of test article

Duration of treatment / exposure:

Tissues were exposed to controls and test article for approximately 60 minutes, with ~35 minutes in a ~37°C, ~5% CO2 in a humidified incubator and the remaining ~25 minutes at room temperature.

Duration of post-treatment incubation (if applicable):

42 ±4 hours post incubation prior to transfer

Number of replicates:

n=6

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

1 hour Mean

Value:

ca. 85.4

Negative controls validity:

valid

Remarks:

100

Positive controls validity:

valid

Remarks:

3.2

Remarks on result:

no indication of irritation

Other effects / acceptance of results:

Negative Control (NC)
The assay meets the acceptance criterion if the Optical Density (OD570) of the NC tissues (treated with DPBS) in the MTT assay is =0.8 and =2.8. This is an indicator of tissue viability following shipping and conditions under use. In this assay, the acceptance criterion was met
with each negative control OD between 1.532 and 1.911.

Positive Control (PC)
5% Sodium Dodecyl Sulfate (SDS) was used as a PC and tested concurrently with the test article. The assay was meeting the acceptance criteria if the mean viability of the positive control, expressed as % of the negative control, results in the categorization of 5% SDS as an
irritant. In this assay, this acceptance criterion was met with mean % viability of 3.2% viable, resulting in the classification as an irritant.

Tested Samples
The assay is meeting the acceptance criteria the standard deviation (SD) calculated from individual percent tissue viabilities of the replicates is =18. In this assay, this acceptance criterion was met with SD <11% for all controls and test materials.

Interpretation of results:

GHS criteria not met

Conclusions:

Substance was demonstrated to be non-irritant in vitro corrosion assay.

Executive summary:

The MatTek EpiDerm™ model was used to assess the potential dermal irritancy of a test article by determining the cell viability of the tissues after exposure to the test article. The pre-testing (color and MTT pre-test) was performed on August 20, 2014 for an earlier study (9131-101131) and it was determined that no freeze killed tissues (background) were required. The dosing and MTT assay for this irritation study were performed on October 15th – 17th. The objective of this study was to assess the dermal irritation potential of the test article. Tissues were exposed to the test article and controls for one hour followed by a 42 hour post-exposure “recover” period. The viability of each tissue was determined by MTT assay. The positive control, 5% SDS, reduced cell viability to 3.2% of control. The test article had minimal effect on the tissue viability (85.4% viable). These data suggest that the test material is non-irritating according to the OECD test guideline using MatTek EpiDerm™ tissues.

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

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available

Justification for type of information:

In vitro eye irritation study is not required because adequate data from an in vivo eye irritation study is available. The in vivo study is considered to be reliable and was conducted before the amendment of the REACH annex for the considerations of non-animals data.

Reference 2

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23rd March 1981 - 22nd May 1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

With 6 animals

GLP compliance:

not specified

Remarks:

Unlikely based on the time of the study

Specific details on test material used for the study:

Description: Off white, very thick liquid
Date of Receipt: February 26, 1981
Storaqe: Room temperature

Test material was heated to 60°C to facilitate handlinq but cooled
prior to dosing. No mixture was required.

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Test Animals: Albino Rabbits
Strain: New Zealand White
Reason for Selection: Standard laboratory animal for ocular evaluations
Number: Six
Age: Young adults
Weiqht: 2.6 to 3.5 kilograms (Pretest)

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 m

Duration of treatment / exposure:

The upper and lower lids were gently held together for one second prior to releasing to Prevent loss of material.

Observation period (in vivo):

Approximately 1, 4, 24, 48, 72 hours, and 4, 7 and 14 days

Number of animals or in vitro replicates:

6 animals

Details on study design:

Preparation‘of Animals: Approximately twenty-four hours before test substance application both eyes of each animal were examined using fluorescein dye to check for presence of corneal ulceration. Just prior to test substance application, the eyes were examined again, but without fluorescein. Animals showing pre—existing corneal or conjunctival injury or irritation were not placed on study.

Administration of Test Substance: One-tenth milliliter (0.1 ml) of the test material was introduced into the lower conjunctival sac of the right eye of each animal. The upper and lower lids were gently held together for one second prior to releasing to Prevent loss of material. The contralateral eye served as the control.

Experimental Evaluation:
Viability Check: Twice Daily
Evaluation of Eye Irritation:
Intervals: Approximately 1, 4, 24, 48 and 72 hours and 4 and 7 days after treatment. If there were no signs of irritation on Day 7, no additional observations were made. If there were signs of irritation on Day 7, observations were made 14 days after treatment.

Methods: At each interval the treated and control eyes were examined and scored for ocular reactions according to the Draize scale. Fluorescein dye was used to confirm presence or absence of corneal ulceration in treated eyes starting with the 24 hour observation and at each subsequent observation until there was no stain retention for two observations. Unusual effects, such as pannus, blistering of the conjunctiva, ulceration and other effects indicative of corrosive action were also noted when present.

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.67

Max. score:

1

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

<1

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

other: Expected to be reversible in 21 Days

Remarks on result:

positive indication of irritation

Remarks:

>=1

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.67

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

<2

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.67

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

<2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

positive indication of irritation

Remarks:

>=1

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible

Remarks on result:

positive indication of irritation

Remarks:

>=1

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

positive indication of irritation

Remarks:

>=2

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.67

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

<2

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.67

Max. score:

1

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

<1

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible

Remarks on result:

positive indication of irritation

Remarks:

>=1

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.67

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

<2

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.67

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

<2

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0.67

Max. score:

1

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

<1

Irritation parameter:

iris score

Basis:

animal #4

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible

Remarks on result:

positive indication of irritation

Remarks:

>=1

Irritation parameter:

conjunctivae score

Basis:

animal #4

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

positive indication of irritation

Remarks:

>=2

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

24/48/72 h

Score:

1.67

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

<2

Irritation parameter:

cornea opacity score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0.67

Max. score:

1

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

<1

Irritation parameter:

iris score

Basis:

animal #5

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible

Remarks on result:

positive indication of irritation

Remarks:

>=1

Irritation parameter:

conjunctivae score

Basis:

animal #5

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

positive indication of irritation

Remarks:

>=2

Irritation parameter:

chemosis score

Basis:

animal #5

Time point:

24/48/72 h

Score:

1.67

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

<2

Irritation parameter:

cornea opacity score

Basis:

animal #6

Time point:

24/48/72 h

Score:

1.3

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

positive indication of irritation

Remarks:

>=1

Irritation parameter:

iris score

Basis:

animal #6

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible

Remarks on result:

positive indication of irritation

Remarks:

>=1

Irritation parameter:

conjunctivae score

Basis:

animal #6

Time point:

24/48/72 h

Score:

1.67

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

<2

Irritation parameter:

chemosis score

Basis:

animal #6

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

positive indication of irritation

Remarks:

<2

Irritant / corrosive response data:

Ulceration of the cornea and necrosis or ulteration of the conjuctivae were observed from the 1 hour observation in all 6 animals. Five out of six animals demonstrated fully recovery by Day 14. Although animals were only observed up to Day14 , based on the recovery of all the other animals it is also expected that the sixth animal is likely to have recovered by Day 21.

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

The Substance is considered to be an eye irritant.

Executive summary:

This study was conducted to evaluate the ocular irritation produced by the Substance. Test material was heated to 60°C to facilitate handlinq but cooled prior to dosing. No mixture was required. Six New Zealand White Rabbits were used. One-tenth milliliter (0.1 ml) of the test material was introduced into the lower conjunctival sac of the right eye of each animal. The upper and lower lids were gently held together for one second prior to releasing to Prevent loss of material. The contralateral eye served as the control.Approximately 1, 4, 24, 48, 72 hours and at 4 , 7 and 14 days after treatment.At each interval the treated and control eyes were examined and scored for ocular reactions according to the Draize scale. Fluorescein dye was used to confirm presence or absence of corneal ulceration in treated eyes starting with the 24 hour observation and at each subsequent observation until there was no stain retention for two observations. Unusual effects, such as pannus, blistering of the conjunctiva, ulceration and other effects indicative of corrosive action were also noted when present.

All animals exhibited positive signs for ocular irritation. Five of the six animals were free of all signs of ocular irritation within 14 days after instillation. Although animals were only observed up to Day14 , based on the recovery of all the other animals it is also expected that the sixth animal is likely to have recovered by Day 21. The Substance is considered to be an eye irritant.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

SKIN

In vitro skin corrosion:

The MatTek EpiDerm™ model was used to assess the potential dermal corrosivity of a test article by determining the cell viability of the tissues after exposure to the test article. The pre-testing (color and MTT pre-test) was performed on August 20, 2014 while the dosing and MTT assay were performed on August 26th. The objective of this study was to assess the dermal corrosion potential of the test article. Tissues were exposed to the test article and controls for three minutes and one hour. The viability of each tissue was determined by MTT assay. The positive control, 8N potassium hydroxide (KOH), reduced cell viability to 30.6% of control after 3 minute exposure and to 5.7 of control after 1 hour exposure. The test article had no effect on the cell viability after 3 minutes exposure (>100% viable) and only a mild effect at 60 minutes exposure (>81% viable). These data suggest that the test material is non-corrosive according to the OECD test guideline using MatTek EpiDerm™ tissues.

In vitro skin Irritation:

The MatTek EpiDerm™ model was used to assess the potential dermal irritancy of a test article by determining the cell viability of the tissues after exposure to the test article. The pre-testing (color and MTT pre-test) was performed on August 20, 2014 for an earlier study (9131-101131) and it was determined that no freeze killed tissues (background) were required. The dosing and MTT assay for this irritation study were performed on October 15th – 17th. The objective of this study was to assess the dermal irritation potential of the test article. Tissues were exposed to the test article and controls for one hour followed by a 42 hour post-exposure “recover” period. The viability of each tissue was determined by MTT assay. The positive control, 5% SDS, reduced cell viability to 3.2% of control. The test article had minimal effect on the tissue viability (85.4% viable). These data suggest that the test material is non-irritating according to the OECD test guideline using MatTek EpiDerm™ tissues.

EYE

In Vitro: Justification for Data Waiving

In vitro eye irritation study is not required because adequate data from an in vivo eye irritation study is available. The in vivo study is considered to be reliable and was conducted before the amendment of the REACH annex for the considerations of non-animals data.

In vivo Eye irritation:

This study was conducted to evaluate the ocular irritation produced by the Substance. Test material was heated to 60°C to facilitate handlinq but cooled prior to dosing. No mixture was required. Six New Zealand White Rabbits were used. One-tenth milliliter (0.1 ml) of the test material was introduced into the lower conjunctival sac of the right eye of each animal. The upper and lower lids were gently held together for one second prior to releasing to Prevent loss of material. The contralateral eye served as the control.Approximately 1, 4, 24, 48, 72 hours and at 4 , 7 and 14 days after treatment.At each interval the treated and control eyes were examined and scored for ocular reactions according to the Draize scale. Fluorescein dye was used to confirm presence or absence of corneal ulceration in treated eyes starting with the 24 hour observation and at each subsequent observation until there was no stain retention for two observations. Unusual effects, such as pannus, blistering of the conjunctiva, ulceration and other effects indicative of corrosive action were also noted when present.

Justification for classification or non-classification

The results of the OECD 431 (in vitro corrosion: RHE) and OECD 439 (In vitro skin irritation: RHE) study considered the registration Substance to not classified as corrosive or irritant to the skin. Based on the data and according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixture, the Substance is not classified for skin irritation.

 

In vitro studies were not conducted as existing in vivo study was available and was conducted before the considerations of in vitro were required under REACH.  The in vivo OECD 405 (Acute Eye Irritation) study conducted with the substance was observed with data that met the GHS criteria for classification. Based on the data the Substance was classified as an eye irritant according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixture. The Substance is classified for serious eye damage category 2 with the hazard statement, H319: Causes serious eye irritation.