Registration Dossier

Administrative data

Description of key information

C12-16 alkyletherdiol was found to be not corrosive to the skin in the in vitro skin corrosion test (OECD 431) anddetermined to be non-irritant to the skinin the in vitro skin irritation test (OECD 439).

In the BCOP test (OECD 437) C12-16 alkyletherdiol induced an IVIS ≤ 3, indicating not to be irritating to the eyes.

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:
14 May 2018 - 18 May 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
Version / remarks:
29 July 2016
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
Version / remarks:
31 May 2008
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
dd. 22 January 2018
Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Cell source:
skin obtained from plastic surgery from multiple donors
Justification for test system used:
Recommended test system in international guidelines (OECD and EC).
Vehicle:
unchanged (no vehicle)
Details on test system:
RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm Skin Model
- Tissue batch number(s): 28356
- Surface: 0.6 cm^2
- Pretreatment: The skin tissues were kept on agarose and storen in the refrigerator the day they were received. The next day, at least 1 hour before the assay was started the tissues were transferred to 6-well plates containing 0.9 ml DMEM per well. The level of the DMEM was just beneath the tissue. The plates were incubated for approximately 2.5 hours at 37.0 ± 1.0ºC.

INTERFERENCE WITH THE MTT ENDPOINT:
- Test for color interference by the test item: 50 μL test item was added to 0.3 mL Milli-Q water and the mixture was incubated for approx. 1 hour at 37.0 ± 1.0°C in the dark. At the end of the exposure time the mixture was shaken and it was checked if a blue/purple color change was observed. A negative control (Milli-Q water) was tested concurrently.
- Test for reduction of MTT by the test item: 25 mg test item was added to 1mL MTT solution (1mg/mL) in phosphate buffered saline. The mixture was incubated for approx. 1 hour at 37.0 ± 1.0°C. At the end of the exposure time it was checked if a blue/purple color change was observed or a blue/purple precipitate was observed. A negative control (Milli-Q water) was tested concurrently.

TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature
- Temperature of post-treatment incubation: 36.3-37.2°C

REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume and number of washing steps: after exposure and after incubation tissues were washed with phosphate buffered saline (once)
- Observable damage in the tissue due to washing: no

MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- Amount of MTT-medium: 300 μL
- MTT concentration: 1 mg/mL
- Incubation time: 3 hours
- Spectrophotometer: TECAN Infinite® M200 Pro Plate Reader
- Wavelength: 570 nm

NUMBER OF REPLICATE TISSUES: 2 per exposure duration + 2 for the negative control and the positive control each

NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: one experiment per exposure period (two in total) with 3 independent OD570 measurements per replicate.

ACCEPTABILITY CRITERIA
- The absolute mean OD570 of the two tissues of the negative control should reasonably be within the acceptance limits of OECD431 (≥0.8 and ≤2.8).
- The mean relative tissue viability following 1-hour exposure to the positive control should be <15 %.
- In the range 20 - 100% viability, the Coefficient of Variation (CV) between tissue replicates should be ≤ 30%.

DECISION CRITERIA (see table 1 in 'any other information on materials and methods')
A test item is considered corrosive in the in vitro skin corrosion test if:
- The relative mean tissue viability obtained after 3-minute treatment compared to the negative control tissues is decreased below 50%.
- In addition, a test item considered non-corrosive (viability ≥ 50%) after the 3-minute treatment is considered corrosive if the relative tissue viability after 1-hour treatment with the test item is decreased below 15%.
A test item is considered non-corrosive in the in vitro skin corrosion test if:
- The relative mean tissue viability obtained after the 3-minute treatment compared to the negative control tissues is not decreased below 50%.
- In addition, the relative tissue viability after the 1-hour treatment is not decreased below 15%.
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
TEST MATERIAL
- Amount applied: 50 μL
- The test item was applied directly on top of the skin tissues

NEGATIVE CONTROL
- Amount applied: 50 μL

POSITIVE CONTROL
- Amount applied: 50 μL (8N KOH)
Duration of treatment / exposure:
3 minute and 1 hour
Duration of post-treatment incubation (if applicable):
3 hours in MTT medium
Number of replicates:
2 tissues per test item per exposure time (4 tissues in total)
Irritation / corrosion parameter:
% tissue viability
Remarks:
Mean of 2 replicates
Run / experiment:
3-minute exposure
Value:
102
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks:
% tissue viability: 9.1
Irritation / corrosion parameter:
% tissue viability
Remarks:
Mean of 2 replicates
Run / experiment:
1-hour exposure period
Value:
93
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks:
% tissue viability: 7.6
Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: no
- Direct-MTT reduction: no
- Colour interference with MTT: no

DEMONSTRATION OF TECHNICAL PROFICIENCY: the results of the positive control data were within the historical data range and thereby showing the test system functioned properly.

ACCEPTANCE OF RESULTS (see table 2 in 'any other information on results' for historical data):
- Acceptance criteria met for negative control: yes, the absolute mean OD570 of the two tissues of the negative control was within the laboratory historical control data range (i.e., 1.760 for the 3-minute exposure period and 1.724 for the 1-hour exposure period).
- Acceptance criteria met for positive control: yes, the mean relative tissue viability following 1-hour exposure to the positive control was <15 % (i.e., 7.6%).
- Acceptance criteria met for variability between replicate measurements: yes, the Coefficient of Variation (CV) between tissue replicates was ≤ 30% (i.e., ≤ 20%)

For individual OD measurements, see table 3 in 'any other information on results'.

Table 2 Historical Control Data

Negative control

Positive control

3-minute treatment

(OD570)

1-hour treatment

(OD570)

3-minute treatment

(OD570)

1-hour treatment

(OD570)

Range

1.258 – 2.615

1.371 – 2.371

0.0172 – 0.56

0.046 – 0.339

Mean

1.80

1.82

0.19

0.14

SD

0.26

0.22

0.09

0.05

n

111

110

106

103

SD = Standard deviation

n = Number of observations

The above mentioned historical control data range of the controls were obtained by collecting all data over the period of November 2014 to November 2017.

Table 3 Individual OD Measurements at 570 nm

 

3-minute application (OD570)

          A                                  B

1-hour application (OD570)

            A                                                B

Negative control

OD570measurement 1

OD570measurement 2

OD570measurement 3

 

 

1.5954

1.9388

1.7355

1.8148

1.6171

2.0210

1.7377

1.7981

1.6223

2.0184

1.7124

1.7972

Test item

OD570measurement 1

OD570measurement 2

OD570measurement 3

 

 

1.7692

1.8490

1.5085

1.8025

1.7916

1.8660

1.4839

1.7657

1.7885

1.9120

1.4760

1.8072

Positive control

OD570measurement 1

OD570measurement 2

OD570measurement 3

 

 

0.2117

0.1925

0.1765

0.1725

0.2120

0.1924

0.1768

0.1708

0.2136

0.1940

0.1722

0.1680

OD = Optical density

Duplicate exposures are indicated by A and B.

Interpretation of results:
study cannot be used for classification
Remarks:
From this single study, no conclusion can be drawn for classification of the test item.
Conclusions:
In the in vitro skin corrosion test, C12-16 alkyletherdiol was found to be not corrosive to the skin (mean tissue viability of 102% and 93% after a 3-minute and a 1-hour exposure period, respectively).
Executive summary:

The objective of this study was to evaluate C12 -16 alkyletherdiol for its ability to induce skin corrosion on a human three dimensional epidermal model (EpiDerm (EPI-200)).  The possible corrosive potential of C12 -16 alkyletherdiol was tested through topical application for 3 minutes and 1 hour.

The study procedures described in this report were based on the most recent OECD and EC guidelines.

Batch D7801-171116001 of the test item was an opaque white to light yellow liquid.  The test item was applied undiluted (50 µL) directly on top of the skin tissue.  

The positive control had a mean relative tissue viability of 7.6% after the 1-hour exposure. The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the acceptance limits of OECD 431 (lower acceptance limit ≥0.8 and upper acceptance limit 2.8) and the laboratory historical control data range.  In the range of 20 - 100% viability the Coefficient of Variation between tissue replicates was 20%, indicating that the test system functioned properly.

Skin corrosion is expressed as the remaining cell viability after exposure to the test item.  The relative mean tissue viability obtained after 3-minute and 1-hour treatments with the test item compared to the negative control tissues was 102% and 93%, respectively.  Because the mean relative tissue viability for the test item was not below 50% after the 3-minute treatment and not below 15% after the 1-hour treatment the test item is considered to be not corrosive.

In conclusion, C12 -16 alkyletherdiol is not corrosive in the in vitro skin corrosion test under the experimental conditions described in this report.

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19 June 2018 - 25 June 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Version / remarks:
28 July 2015
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
Version / remarks:
20 July 2012
Deviations:
no
GLP compliance:
yes
Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Cell source:
skin obtained from plastic surgery from multiple donors
Vehicle:
unchanged (no vehicle)
Details on test system:
RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPISKIN Small Model(TM) (EPISKIN-SM(TM), 0.38 cm^2)
- Tissue batch number(s): 18-EKIN-025
- Expiration date: 25 June 2018

TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature
- Temperature of post-treatment incubation (if applicable): 36.6 - 37.3°C

REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: once with phosphate buffered saline
- Observable damage in the tissue due to washing: no

MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 0.3 mg/mL
- Incubation time: 3 hours
- Spectrophotometer: TECAN Infinite® M200 Pro Plate Reader
- Wavelength: 570 nm

FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Histology scoring: 22.4 +/- 0.4
- Satisfactory epidermis layer
- Contamination: on blood of the same donors it was verified that there was an absence of HIV 1 and 2 antibodies, hepatitis C antibodies, hepatitis B antigen HBs. On epidermal cells of the same donors it was verified that there was an absence of bacteria, fungus and mycoplasma.

NUMBER OF REPLICATE TISSUES: 3 replicates for the test item, positive control and negative control exposed skin tissues each. OD measurements on each replicate were performed in duplicate.

MTT DIRECT INTERFERENCE:
- The test item was checked for direct MTT reduction and interference in a previous study and was concluded that it did not interfere with the MTT endpoint.

PREDICTION MODEL / DECISION CRITERIA (see table 1)
A test item is considered irritant in the skin irritation test if:
- The relative mean tissue viability of three individual tissues after 15 minutes of exposure to the test item and 42 hours of post incubation is ≤ 50% of the mean viability of the negative controls.
A test item is considered non-irritant in the in vitro skin irritation test if:
- The relative mean tissue viability of three individual tissues after 15 minutes of exposure to the test item and 42 hours of post incubation is > 50% of the mean viability of the negative controls.

ACCEPTABILITY CRITERIA:
- The absolute mean OD570 (optical density at 570 nm) of the three tissues of the negative control should reasonably be within the laboratory historical control data range and the Standard Deviation value (SD) of the % viability should be ≤18.
- The mean relative tissue viability of the positive control should be ≤40% relative to the negative control and the Standard Deviation value (SD) of the % viability should be ≤18.
- The SD calculated from individual % tissue viabilities of the three identically treated replicates should be ≤18.
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
- Test item: 25 µL
- Positive control: 25 µL
- Negative control: 25 µL (re-spread after 7 minutes contact time)
Duration of treatment / exposure:
15 ± 0.5 minutes
Duration of post-treatment incubation (if applicable):
42 hours, followed by 3 hours with MTT
Number of replicates:
3
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
Mean of 3 replicates
Value:
94
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks:
Tissue viability: 7.3%
Other effects / acceptance of results:
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes, the absolute mean OD570 of the negative control tissues was within the laboratory historical control data range
- Acceptance criteria met for positive control: yes, the positive control had a mean cell viability after 15 ± 0.5 minutes exposure of 7.3%.
- Acceptance criteria met for variability between replicate measurements: yes, the standard deviation value of the percentage viability of three tissues treated identically was ≤ 15%

Table 2 Individual OD measurements

 

A

(OD570)

B

(OD570)

C

(OD570)

Negative control

OD570measurement 1

OD570measurement 2

 

1.0123

0.9921

 

0.9900

0.9680

 

1.0793

1.0356

C12 – 16 alkyletherdiol

OD570measurement 1

OD570measurement 2

 

1.0541

0.9632

 

0.8191

0.7612

 

1.1004

1.0296

Positive control

OD570measurement 1

OD570measurement 2

 

0.1118

0.1180

 

0.1221

0.1175

 

0.0982

0.1070

OD = Optical density

Triplicate exposures are indicated by A, B and C.

Interpretation of results:
GHS criteria not met
Remarks:
Not classified according to Regulation (EC) No. 1272/2008.
Conclusions:
Based on the results of an in vitro skin irritation study, performed according to OECD guideline 439 and GLP principles, C12 – 16 alkyletherdiol is determined to be non-irritant to the skin (mean tissue viability of 94%).
Executive summary:

The objective of this study was to evaluate C12-16 alkyletherdiol for its ability to induce skin irritation on a human three dimensional epidermal model (EPISKIN Small model (EPISKIN-SMTM)). The possible skin irritation potential of C12-16 alkyletherdiol was tested through topical application for 15 minutes.

The study procedures described in this report were based on the most recent OECD and EC guidelines.

Batch D7801-171116001 of the test item was an opaque white to light yellow liquid. The test item was applied undiluted (25 µL) directly on top of the skin tissue for 15 ± 0.5 minutes.

After a 42 hour post-incubation period, determination of the cytotoxic (irritancy) effect was performed. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment.

Skin irritation is expressed as the remaining cell viability after exposure to the test item. The relative mean tissue viability obtained after 15 ± 0.5 minutes treatment with the test item compared to the negative control tissues was 94%. Since the mean relative tissue viability for the test item was above 50% after 15 ± 0.5 minutes treatment the test item is considered to be non-irritant.

 

The positive control had a mean cell viability of 7.3% after 15 ± 0.5 minutes exposure. The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the laboratory historical control data range. The standard deviation value of the percentage viability of three tissues treated identically was ≤ 15%, indicating that the test system functioned properly.

In conclusion, C12-16 alkyletherdiol is non-irritant in the in vitro skin irritation test under the experimental conditions described in this report and should not be classified according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations.

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:
08 May 2018 - 15 May 2018.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
Version / remarks:
09 October 2017
Deviations:
no
GLP compliance:
yes
Species:
cattle
Details on test animals or tissues and environmental conditions:
SOURCE OF COLLECTED EYES
- Source: young cattle, obtained from the slaughterhouse Vitelco, 's-Hertogenbosch, The Netherlands.
- Storage, temperature, and transport conditions of ocular tissue: eyes were excised by a slaughterhouse employee as soon as possible after slaughter. Subsequently, eyes were collected an transported in physiological saline in a suitable container under cooled conditions.
- The eyes were checked for unacceptable defects and those exhibiting defects were discarded.
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 750 µL
Duration of treatment / exposure:
10 ± 1 minutes
Duration of post- treatment incubation (in vitro):
120 ±10 minutes in cMEM for opacity measurements and subsequently 90 ± 5 minutes in sodium-fluorescein for permeability determinations
Number of animals or in vitro replicates:
3 replicates for the negative, positive, and treatment group each.
Details on study design:
TREATMENT METHOD: The medium from the anterior compartment was removed and 750 µL of either the negative control, positive control or the test item was introduced onto the epithelium of the cornea. The holders were slightly rotated, with the corneas maintained in a horizontal position, to ensure uniform distribution of the control or the test item over the entire cornea. Corneas were incubated in a horizontal position for 10 ± 1 minutes at 32.0 ± 1°C.

REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: After the incubation the solutions were removed and the epithelium was washed with MEM with phenol red (Earle’s Minimum Essential Medium, Life Technologies) and thereafter with cMEM (MEM containing 1% (v/v) L-glutamine and 1% (v/v) Foetal Bovine Serum).
- POST-EXPOSURE INCUBATION: 120 ±10 minutes in cMEM for opacity measurements and subsequently 90 ±5 minutes in sodium-fluorescein for permeability determinations

METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: opacity meter (OP-KIT)
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of a microtiter plate reader (TECAN Infinite® M200 Pro Plate Reader, OD490). OD490 values of less than 1.500 were used in the permeability calculation.
- Other: possible pH effects of the test substance on the corneas were recorded.


SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
The mean opacity and mean permeability values (OD490) were used for each treatment group to calculate an in vitro score:
In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value).

ACCEPTABILITY CRITERIA
The assay is considered acceptable if:
a) The positive control gives an in vitro irritancy score that falls within two standard deviations of the current historical mean.
b) The negative control responses should result in opacity and permeability values that are less than the upper limits of the laboratory historical range.

DECISION CRITERIA (see table 1):
A test substance that induces an IVIS ≤ 3 is not classified for eye irritancy (UN GHS: no category);
A test substance that induces IVIS >55 is defined as a corrosive or severe irritant (UN GHS: category 1);
For a test substance that induces an IVIS >3 and ≤55, no prediction on irritant potency can be made.
Irritation parameter:
in vitro irritation score
Run / experiment:
Mean of 3 replicates
Value:
-0.3
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks:
Mean IVIS: 40
Remarks on result:
no indication of irritation
Other effects / acceptance of results:
- The corneas treated with the test item showed opacity values between -0.8 and 0.2
- Permeability values were ranging from 0.001 to 0.003
- Individual IVIS scores were 0.2, -0.5, -0.7 (n=3)

OTHER EFFECTS:
- No pH effect of the test item was observed on the rinsing medium

ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes, results were within historical range (IVIS ranging from 0.8 to 2.7).
- Acceptance criteria met for positive control: yes, results were within historical range (IVIS ranging from 31 to 48).
Interpretation of results:
GHS criteria not met
Conclusions:
A Bovine Corneal Opacity and Permeability test (BCOP) was performed according to OECD guideline 437 and GLP principles. C12-16 alkyletherdiol induced an IVIS ≤ 3, therefore no classification is required for eye irritation or serious eye damage.
Executive summary:

The objective of this study was to evaluate the eye hazard potential of C12-16 alkyletherdiol as measured by its ability to induce opacity and increase permeability in an isolated bovine cornea using the Bovine Corneal Opacity and Permeability test (BCOP test).

This report describes the potency of chemicals to induce serious eye damage using isolated bovine corneas. The eye damage of the test item was tested through topical application for 10 minutes.

The study procedures described in this report were based on the most recent OECD guideline.

Batch D7801-171116001 of the test item was an opaque white to light yellow liquid. The test item was applied as it is (750 µL) directly on top of the corneas.

The negative control responses for opacity and permeability were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas. The mean in vitro irritancy score of the positive control (Ethanol) was 40 and was within two standard deviations of the current historical positive control mean. It was therefore concluded that the test conditions were adequate and that the test system functioned properly.

C12 – 16 alkyletherdiol did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of -0.3 after 10 minutes of treatment.

In conclusion, since C12 -16 alkyletherdiol induced an IVIS ≤ 3, no classification is required for eye irritation or serious eye damage.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In vitro dermal corrosion (OECD 431):

C12-16 alkyletherdiol was evaluated for its ability to induce skin corrosion on a human three dimensional epidermal model (EpiDerm (EPI-200)).  The possible corrosive potential of C12-16 alkyletherdiol was tested through topical application for 3 minutes and 1 hour.

The test item was applied undiluted (50 µL) directly on top of the skin tissue.

All study performance criteria were met, indicating that the test system functioned properly.

The relative mean tissue viability obtained after 3-minute and 1-hour treatments with the test item compared to the negative control tissues was 102% and 93%, respectively.

In conclusion, C12 -16 alkyletherdiol is not corrosive in the in vitro skin corrosion test under the experimental conditions described in this report.

 

In vitro dermal irritation (OECD 439):

C12-16 alkyletherdiol was evaluated for its ability to induce skin irritation on a human three dimensional epidermal model (EPISKIN Small model (EPISKIN-SMTM)). 

The test item was applied undiluted (25 µL) directly on top of the skin tissue for 15 ± 0.5 minutes.

After a 42 hour post-incubation period, determination of the cytotoxic (irritancy) effect was performed. 

Skin irritation is expressed as the remaining cell viability after exposure to the test item.

All study performance criteria were met, indicating that the test system functioned properly.

The relative mean tissue viability obtained after 15 ± 0.5 minutes treatment with the test item compared to the negative control tissues was 94%. Since the mean relative tissue viability for the test item was above 50% after 15 ± 0.5 minutes treatment the test item is considered to be non-irritant.

 

In vitro eye irritation(BCOP, OECD 437):

The eye hazard potential of C12-16 alkyletherdiol was measured by its ability to induce opacity and increase permeability in an isolated bovine cornea using the Bovine Corneal Opacity and Permeability test (BCOP test).

The eye damage of the test item was tested through topical application for 10 minutes. The test item was applied as it is (750 µL) directly on top of the corneas.

The negative and positive controls showed appropriate results and it was concluded that the test conditions were adequate and that the test system functioned properly.

C12-16 alkyletherdiol did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of -0.3 after 10 minutes of treatment.

Justification for classification or non-classification

C12-16 alkyletherdiol was found to be not corrosive to the skin in the in vitro skin corrosion test (OECD 431) anddetermined to be non-irritant to the skinin the in vitro skin irritation test (OECD 439). No classification is required for skin irritation or corrosion.

Since C12-16 alkyletherdiol induced an IVIS ≤ 3, no classification is required for eye irritation or serious eye damage.