Reaction mass of hexadecyl dihydrogen phosphate and cetyl alcohol (mono- C16 PSE and C16-OH)

Endpoint summary

Description of key information

Based on the results of the in vitro studies, the test substance, ‘mono- C16 PSE and C16 -OH’, is considered to be non-irritant to skin and corrosive to the eyes.

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Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From May 16, 2017 to June 16, 2017

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)

Deviations:

yes

Remarks:

see "Principles of method if other than guideline"

Principles of method if other than guideline:

Optical Density (OD) values obtained with blanks were higher than 0.1 (0.191) causing a deviation from Acceptance Criteria 4. However, this SOP and guideline deviation was not considered to have affected the integrity or interpretation of the results as no equivocal results were obtained.

GLP compliance:

yes (incl. QA statement)

Test system:

human skin model

Remarks:

MatTek EpiDermTM tissue model EPI-200

Justification for test system used:

Initially the predictive capacity of the modified EpiDerm™ Skin Irritation Test (SIT) test method, using MatTek EpiDermTM tissue model EPI-200, underwent full prospective validation from 2003-2007. The test method components of this method were used to define the essential test methods components of the original and updated ECVAM Performance Standards (PS). A modification of the original EpiDerm™ SIT was validated using the original ECVAM PS in 2008. In 2008, ESAC concluded that the Modified EpiDerm™ SIT has sufficient accuracy and reliability for prediction of R38 skin irritating and no-label (non-skin irritating) test substances.

Vehicle:

unchanged (no vehicle)

Details on test system:

Test system:
The reconstructed human epidermal model EpiDermTM (EPI-200-MatTek Corporation) consists of normal human-derived epidermal keratinocytes which have been cultured to form a multi-layered highly differentiated model of the human epidermis. It consists of organised basal, spinous and granular layers and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo.

Characterisation of the test system:
MatTek’s EpiDermTM model has been extensively characterised for multiple parameters including morphology, tissue viability, skin barrier function and sterility. QC results for the specific lot of models received (Lot# 25819) were checked in-house for MatTek acceptance ranges with the following outcome:

- Morphology - PASS
- Tissue viability - PASS
- Skin barrier function (ET50 value for 1 % Triton X-100) where ET50 is the time taken for 1 % Triton X-100 to reduce the viability of the skin model to 50 % relative to the negative control) - PASS
- Sterility testing showed no contamination during long term antibiotic and antimycotic free culture - PASS

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

25 mg (nominal) of the neat test substance after pre-wetting tissues with 25 μL DPBS (Sterile Dulbecco’s Phosphate Buffered Saline).

Duration of treatment / exposure:

60 minutes (25 minutes at room temperature and 35 minutes at 37°C, 5 % CO2).

Duration of post-treatment incubation (if applicable):

42 h post-treatment incubation.

Number of replicates:

3 replicates for test substance, negative and positive control.

Irritation / corrosion parameter:

% tissue viability

Value:

89.1

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

- Prior to the study, the required compatibility checks (as per SOP L0029) confirmed that the test substance did not interfere with MTT and no water colouration was observed.
- The test substance did reduce the viability below 50 % and should be considered as irritant to the skin.

All acceptance criteria were met with the exception of 1 criterion:

- The mean OD570 of the negative control (treated with DPBS) tissues is ≥0.8 and ≤2.8.
Result: 1.777
- The mean of the positive control relative percentage viability must be ≤20 % of the mean of the negative controls.
Result: 3.8 %
- The standard deviation of OD values for triplicate skin models in each experimental condition must be <18 %.
Results:
NC: 5 %
PC: 0.72 %
Test substance: 16.17 %
- The mean OD of the 6 wells containing extraction solvent alone (blanks) should be ≤0.1.
Result: 0.191

Optical Density (OD) values obtained with blanks were higher than 0.1 (0.191) causing a deviation from Acceptance Criteria 4. However, the spectrophotometer was fully validated and had passed all required tests. The OD values for blanks observed in this study are consistent with historical data using this spectrophotometer in the laboratory and meet our current internal acceptance criteria of blank OD values <0.194 (mean of historical data, based on blanks obtained during the last 66 studies), therefore this is not considered to be an issue in the interpretation of this study data.
This SOP and guideline deviation was not considered to have affected the integrity or interpretation of the results as no equivocal results were obtained.

Interpretation of results:

other: CLP criteria not met

Remarks:

non-irritant to skin

Conclusions:

Under the study conditions, the test substance was determined to be non-irritant to the skin.

Executive summary:

An in vitro study was conducted to determine the skin irritation potential of the test substance, 'mono- C16 PSE and C16 -OH' (purity not specified), in Reconstructed Human Epidermis (RHE) cells, according to OECD Guideline 439, in compliance with GLP. Three tissues of the human skin model EpiDermTM were treated with the test substance, positive or negative control for 60 minutes (25 minutes at room temperature and 35 minutes at 37°C, 5 % CO2, 95 % RH) and 42 h post incubation period. Test was performed with 3 replicates for each type of treatment. Tissues were first pre-wetted with 25 μL DPBS (Sterile Dulbecco’s Phosphate Buffered Saline), subsequently 25 mg (nominal) of the neat test substance was applied. 30 μL of DPBS was used as negative control and 5% of sodium dodecyl sulphate as positive control. Viability of the tissues was assessed in MTT test and compared to the negative control. The percentage of viability obtained with the test substance was 89.1%, which is well above the irritant limit of 50%. The study met all the validity criteria. Under the study conditions, the test substance was determined to be non-irritant to the skin (XCellR8, 2017).

Reference 2

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From November 24, 2004 to December 02, 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)

Version / remarks:

Report from 2004 before Guideline implementation

Deviations:

no

GLP compliance:

not specified

Specific details on test material used for the study:

Appearance: white powder

Test system:

artificial membrane barrier model

Remarks:

Corrositex test

Vehicle:

unchanged (no vehicle)

Details on test system:

The Corrositex test is a standardized and reproducible method that can be employed to determine the potential corrosivity and the packing group classification of specified categories of chemical compounds under the hazardous materials transportation regulations administrated by the U.S. Department of Transportation (DOT) and international dangerous goods codes. The Corrositex test predicts the in vitro corrosive potential of a chemical compound or mixture by using as an endpoint the amount of time it takes for chemical to permeate through or destroy a synthetic biobarrier. A color change in a proprietary liquid Chemical Detection System (CDS) is used to indicate that the chemical has passed through the biobarrier.

Control samples:

yes, concurrent positive control

Amount/concentration applied:

neat test substance

Duration of treatment / exposure:

240 minutes

Number of replicates:

4

Amount / concentration applied:

100 %

Irritation / corrosion parameter:

penetration time (in minutes)

Run / experiment:

All 4 replicates

Value:

> 65

Vehicle controls validity:

not applicable

Negative controls validity:

not applicable

Positive controls validity:

not applicable

Remarks on result:

other: non-corrosive

Other effects / acceptance of results:

Corrositex time [minutes] for all 4 replicates: >65 min
pH measured in 10 % aqueous test solution: 2.1
Color in tube A: yellow
pH in measure in tube A 6.4
Category: 2
Packing group: non-corrosive

The results of the study indicated that the sample was compatible with Corrositex system and was determined to be a category 2 sample. The results obtained from the evaluation of four replicate samples were consistent, demonstrating that a mean time of >65 minutes was required to destroy the synthetic biobarriers. This findings lead to the classification of the test substance as a non-corrosive material.

Interpretation of results:

other: CLP criteria not met

Remarks:

non-corrosive

Conclusions:

Under the study conditions, the test substance is classified as a non-corrosive material according to U.S department of transport and international dangerous goods codes.

Executive summary:

An in vitro study was conducted to determine the in skin corrosion potential and packing group designation of the test substance, 'mono- C16 PSE and C16-OH' (purity not specified), according to Corrositex test method. The Corrositex test predicts the in vitro corrosive potential of a chemical compound or mixture by using as an endpoint, the amount of time it takes for chemical to permeate through or destroy a synthetic biobarrier. A color change in a proprietary liquid Chemical Detection System (CDS) is used to indicate that the chemical has passed through the biobarrier. Four samples were examined with application of neat test substance (100%). The test substance was compatible with Corrositex system. The results obtained from the evaluation of four replicate samples were consistent, demonstrating that a mean time of >65 minutes was required to destroy the synthetic biobarriers. Under the study conditions, the test substance is classified as a non-corrosive material according to U.S department of transport and international dangerous goods codes (MBRL, 2004).

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:

July 04, 2017

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)

Deviations:

yes

Remarks:

Deviations were considered to have not affected the integrity or validity of the study

Qualifier:

according to guideline

Guideline:

EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)

Deviations:

yes

Remarks:

Deviations were considered to have not affected the integrity or validity of the study

GLP compliance:

yes (incl. QA statement)

Species:

cattle

Strain:

not specified

Details on test animals or tissues and environmental conditions:

Source of Bovine Eyes
Eyes from adult cattle (typically 12 to 60 months old) were obtained from a local abattoir as a by-product from freshly slaughtered animals. The eyes were excised by an abattoir employee after slaughter, and were placed in Hanks’ Balanced Salt Solution (HBSS) supplemented with antibiotics (penicillin at 100 IU/mL and streptomycin at 100 µg/mL). They were transported to the test facility over ice packs on the same day of slaughter. The corneas were prepared immediately on arrival.

Vehicle:

physiological saline

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

0.75 mL test substance or reference substances (Positive control: 20% w/v imidazole solution in sodium chloride 0.9% w/v, Negative control: Sodium chloride 0.9% w/v)

Duration of treatment / exposure:

At 32 ± 1 ºC for 240 minutes

Duration of post- treatment incubation (in vitro):

At 32 ± 1 ºC for 90 minutes for permeablity assessment

Number of animals or in vitro replicates:

Three corneas to each test substance and reference substances

Details on study design:

Preparation of corneas
All eyes were macroscopically examined before and after dissection. Only corneas free of damage were used. The cornea from each selected eye was removed leaving a 2 to 3 mm rim of sclera to facilitate handling. The iris and lens were peeled away from the cornea. The isolated corneas were immersed in a dish containing HBSS until they were mounted in Bovine Corneal Opacity and Permeability (BCOP) holders. The anterior and posterior chambers of each BCOP holder were filled with complete Eagle’s Minimum Essential Medium (EMEM) without phenol red and plugged. The holders were incubated at 32 ± 1 ºC for 70 minutes. At the end of the incubation period each cornea was examined for defects. Only corneas free of damage were used.
 
Selection of corneas and opacity reading
The medium from both chambers of each holder was replaced with fresh complete EMEM. A pre‑treatment opacity reading was taken for each cornea using a calibrated opacitometer.Three corneas were randomly allocated to the negative control. Three corneas were also allocated to the test substance and three corneas to the positive control substance.
 
Treatment of corneas
The EMEM was removed from the anterior chamber of the BCOP holder and 0.75 mL of the test substance preparation or control substances were applied to the appropriate corneas. The holders were gently tilted back and forth to ensure a uniform application of the substance over the entire cornea. Each holder was incubated, anterior chamber uppermost, at 32 ± 1 ºC for 240 minutes. At the end of the exposure period the test substance and control substances were removed from the anterior chamber and the cornea was rinsed three times with fresh complete EMEM containing phenol red before a final rinse with complete EMEM without phenol red. The anterior chamber was refilled with fresh complete EMEM without phenol red. A post‑treatment opacity reading was taken and each cornea was visually observed. The negative and positive control data was shared with Envigo study number NX25RF and LM55TK.
 
Application of sodium fluorescein
Following the opacity measurement the permeability of the corneas to sodium fluorescein was evaluated. The medium from the anterior chamber was removed and replaced with 1 mL of sodium fluorescein solution (5 mg/mL). The dosing holes were plugged and the holders incubated, anterior chamber uppermost, at 32 ± 1 ºC for 90 minutes.
 
Permeability determinations
After incubation the medium in the posterior chamber of each holder was decanted and retained.360 µL of media representing each cornea was dispensed into the appropriate wells of a pre‑labeled 96‑well plate. The optical density was measured (quantitative viability analysis) at 492 nm (without a reference filter) using the Labtech LT-4500 microplate reader.
 
Histopathology
The corneas were retained after testing for possible conduct of histopathology. Each cornea was placed into a pre‑labeled tissue cassette fitted with a histology sponge to protect the endothelial surface. The cassette was immersed in 10% neutral buffered formalin. In this study histopathology was not required.
 
Data evaluation
Results from the two test method endpoints, opacity and permeability, were combined in an empirically derived formula to generate an In Vitro Irritancy Score.
 
Opacity measurement
The change in opacity for each cornea (including the negative control) was calculated by subtracting the initial opacity reading from the final opacity reading. These values were then corrected by subtracting the average change in opacity observed for the negative control corneas. The mean opacity value of each treatment group was then calculated by averaging the corrected opacity values of each cornea for that treatment group.
 
Permeability measurement
The corrected OD492 was calculated by subtracting the mean OD492 of the negative control corneas from the OD492 value of each treated cornea. The OD492 value of each treatment group was calculated by averaging the corrected OD492 values of the treated corneas for the treatment group.
 
In Vitro irritancy score
The following formula was used to determine the In Vitro Irritancy Score:
In Vitro Irritancy Score = mean opacity value + (15 x mean permeability OD492 value)
 
Additionally, the opacity and permeability values were evaluated independently to determine whether the test substance induced a response through only one of the two endpoints.
 
Visual observation
The condition of the cornea was visually assessed post treatment.

Irritation parameter:

in vitro irritation score

Run / experiment:

Test substance

Value:

ca. 77

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Irritation parameter:

in vitro irritation score

Run / experiment:

Positive control

Value:

ca. 127

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Irritation parameter:

in vitro irritation score

Run / experiment:

Negative control

Value:

ca. 1.4

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Other effects / acceptance of results:

The positive control In Vitro Irritancy Score was above the range of 65.1 to 123.3. The positive control acceptance criterion was therefore not satisfied. This was reported as a deviation. The negative control gave opacity of ≤2.4 and permeability ≤0.072. The negative control acceptance criteria were therefore satisfied.

Results

Corneal Opacity and Permeability measurement

Individual and mean corneal opacity measurements and individual and mean corneal permeability measurements are given in following table 1:

Treatment	Cornea number	Opacity				Permeability (OD^492)		In Vitro Irritancy Score
		Pre-Treatment	Post-Treatment	Post-Treatment-Pre‑Treatment	Corrected Value		Corrected Value
Negative ControlÅ	1	3	4	1		0.012
	2	3	4	1		0.000
	3	2	4	2		0.000
	Mean			1.3		0.004		1.4
Positive Control^Å	4	2	105	103	101.7	3.965	3.961
	5	2	88	86	84.7	1.895	1.891
	6	2	83	81	79.7	1.820	1.816
	Mean				88.7		2.556	127.0
Test Substance	10	2	74	72	70.7	0.007	0.003
	11	2	82	80	78.7	0.000	0.000
	12	3	86	83	81.7	0.000	0.000
	Mean				77.0		0.001	77.0

 

Corneal Epithelium Condition

The condition of each cornea is given in below table 2:

Treatment	Cornea number	observation post treatment
Negative Control*	1	Clear
	2	Clear
	3	Clear
Positive Control*	4	Cloudy
	5	Cloudy
	6	Cloudy
Test Substance	10	Cloudy
	11	Cloudy
	12	Cloudy

* = Control data shared with Envigo study number NX25RF and LM55TK

The corneas treated with the test substance were cloudy post treatment. The corneas treated with the negative control substance were clear post treatment. The corneas treated with the positive control substance were cloudy post treatment.

In Vitro Irritancy Score

The In Vitro irritancy scores are summarized as follows:

Treatment	In Vitro Irritancy Score
Test Substance	77.0
Negative Control	1.4
Positive Control	127.0

Criteria for an Acceptable Test

The positive control In Vitro Irritancy Score was above the range of 65.1 to 123.3. The positive control acceptance criterion was therefore not satisfied. This is reported as a deviation.

The negative control gave opacity of ≤2.4 and permeability ≤0.072. The negative control acceptance criteria were therefore satisfied.

Conclusion

Category 1. UN GHS or EU CLP Causes serious eye damage

Interpretation of results:

other: Category 1 (irreversible effects on the eye) based on EU CLP criteria

Conclusions:

Under the study conditions, the test substance was considered to be corrosive.

Executive summary:

A study was conducted to determine the eye irritation potential of the test substance, 'mono- C16 PSE and C16-OH' (100 %), using Bovine corneal Opacity Test (BCOP), according to OECD Guideline 437 and EU Method B.47, in compliance with GLP. Eyes from adult cattle (typically 12 to 60 months old) were obtained from a local abattoir as a by-product from freshly slaughtered animals. Preparation, selection and opacity reading of the corneas were performed as per guideline. Prepared corneas in triplicates were treated with each, test substance (20% w/v in sodium chloride 0.9% w/v), negative control (Sodium chloride 0.9% w/v) and positive control (20% w/v Imidazole solution in sodium chloride 0.9% w/v) substances at 32 ± 1ºC for 240 minutes. At the end of the exposure period the test substance and control substances were removed from the anterior chamber and the cornea was rinsed three times with fresh complete Eagle’sMinimum Essential Medium (EMEM) containing phenol red before a final rinse with complete EMEM without phenol red. A post treatment opacity reading was taken and each cornea was visually observed. The negative and positive control data was shared with Envigo study number LM55TK and NX25RF. Following the opacity measurement the permeability of the corneas to sodium fluorescein was evaluated. The medium from the anterior chamber was removed and replaced with 1 mL of sodium fluorescein solution (5 mg/mL). The dosing holes were plugged and the holders incubated, anterior chamber uppermost, at 32 ± 1ºC for 90 minutes. The two endpoints, decreased light transmission through the cornea (opacity) and increased passage of sodium fluorescein dye through the cornea (permeability) were combined in an empirically derived formula to generate an In Vitro Irritancy Score (IVIS). The positive control group had an overall IVIS of 127.0, which was marginally higher than the criteria range set for an acceptable test. However, as the score was only marginally exceeded, the study author decided that this result was acceptable as the positive control group was still providing its intended function, which is to show the sensitivity of the test system to a known ocular irritant. The negative control gave opacity of ≤2.4 and permeability ≤0.072, the negative control acceptance criteria were therefore satisfied. The test substance IVIS score obtained was 77, which is well above the threshold for corrosive classification. Under the study conditions, the test substance was considered to be corrosive and classified as Category 1 or Eye Damage 1 - H318: causes serious eye damage, according to UN GHS or EU CLP (Envigo, 2018).

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin:

Study 1: An in vitro study was conducted to determine the in skin corrosion potential and packing group designation of the test substance, mono- C16 PSE + C16-OH (Purity not specified), according to Corrositex test method. The Corrositex test predicts the in vitro corrosive potential of a chemical compound or mixture by using as an endpoint, the amount of time it takes for chemical to permeate through or destroy a synthetic biobarrier. A color change in a proprietary liquid Chemical Detection System (CDS) is used to indicate that the chemical has passed through the biobarrier. Four samples were examined with application of neat test substance (100%). The test substance was compatible with Corrositex system. The results obtained from the evaluation of four replicate samples were consistent, demonstrating that a mean time of >65 minutes was required to destroy the synthetic biobarriers. Under the study conditions, the test substance is classified as a non-corrosive material according to U.S department of transport and international dangerous goods codes (MBRL, 2004).

Study 2: An in vitro study was conducted to determine the skin irritation potential of the test substance, 'mono- C16 PSE and C16 -OH' (purity not specified), in Reconstructed Human Epidermis (RHE) cells, according to OECD Guideline 439, in compliance with GLP. Three tissues of the human skin model EpiDermTM were treated with the test substance, positive or negative control for 60 minutes (25 minutes at room temperature and 35 minutes at 37°C, 5 % CO2, 95 % RH) and 42 h post incubation period. Test was performed with 3 replicates for each type of treatment. Tissues were first pre-wetted with 25 μL DPBS (Sterile Dulbecco’s Phosphate Buffered Saline), subsequently 25 mg (nominal) of the neat test substance was applied. 30 μL of DPBS was used as negative control and 5% of sodium dodecyl sulphate as positive control. Viability of the tissues was assessed in MTT test and compared to the negative control. The percentage of viability obtained with the test substance was 89.1%, which is well above the irritant limit of 50%. The study met all the validity criteria. Under the study conditions, the test substance was determined to be non-irritant to the skin (XCellR8, 2017).

Eye:

A study was conducted to determine the eye irritation potential of the test substance, 'mono- C16 PSE and C16-OH' (100 %),using Bovine corneal Opacity Test (BCOP), according to OECD Guideline 437 and EU Method B.47, in compliance with GLP. Eyes from adult cattle (typically 12 to 60 months old) were obtained from a local abattoir as a by-product from freshly slaughtered animals. Preparation, selection and opacity reading of the corneas were performed as per guideline. Prepared corneas in triplicates were treated with each, test substance (20% w/v in sodium chloride 0.9% w/v), negative control (Sodium chloride 0.9% w/v) and positive control (20% w/v Imidazole solution in sodium chloride 0.9% w/v) substances at 32 ± 1ºC for 240 minutes. At the end of the exposure period the test substance and control substances were removed from the anterior chamber and the cornea was rinsed three times with fresh completeEagle’sMinimum Essential Medium (EMEM) containing phenol red before a final rinse with complete EMEM without phenol red. A post treatment opacity reading was taken and each cornea was visually observed. The negative and positive control data was shared with Envigo study number LM55TK and NX25RF. Following the opacity measurement the permeability of the corneas to sodium fluorescein was evaluated. The medium from the anterior chamber was removed and replaced with 1 mL of sodium fluorescein solution (5 mg/mL). The dosing holes were plugged and the holders incubated, anterior chamber uppermost, at 32 ± 1ºC for 90 minutes. The two endpoints, decreased light transmission through the cornea (opacity) and increased passage of sodium fluorescein dye through the cornea (permeability) were combined in an empirically derived formula to generate an In Vitro Irritancy Score (IVIS). The positive control group had an overall IVIS of 127.0, which was marginally higher than the criteria range set for an acceptable test. However, as the score was only marginally exceeded, the study author decided that this result was acceptable as the positive control group was still providing its intended function, which is to show the sensitivity of the test system to a known ocular irritant. The negative control gave opacity of ≤2.4 and permeability ≤0.072, the negative control acceptance criteria were therefore satisfied. The test substance IVIS score obtained was 77, which is well above the threshold for corrosive classification. Under the study conditions, the test substance was considered to be corrosive and classified as Category 1 or Eye Damahge 1 - H318: causes serious eye damage, according to UN GHS or EU CLP (Envigo, 2018).

Justification for classification or non-classification

Skin irritation:

Based on the results of in vitro skin irritation/corrosion studies, the test substance, ‘mono- C16 PSE and C16 -OH', does not warrant classification for skin irritation according to the EU CLP criteria (Regulation 1272/2008/EC).

Eye irritation:

Based on the results of read across in vitro eye irritation study (BCOP), the ‘mono- C16 PSE and C16 -OH’ warrants an ‘Eye damage 1: H318- causes serious eye damage’ classification according to the EU CLP criteria (Regulation EC 1272/2008). Labelling for this endpoint should include “Danger” as signal word.