Fatty acids, C10-12, esters with polylactic acid, sodium salts

Endpoint summary

Description of key information

Skin corrosion (OECD 431, EPIDERM): not corrosive

Skin irritation (OECD 439, EPISKIN): not irritating

Serious eye damage (OECD 437, BCOP): not causing serious eye damage

Eye irritation (OECD 492, EpiOcular): irritating or causing serious eye damage

Weight-of-Evidence conclusion on eye irritation / serious eye damage: irritating

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:

18 - 21 October 2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)

GLP compliance:

yes (incl. QA statement)

Remarks:

Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, Kaiser-Friedrich-Str. 7, 55116 Mainz, Germany

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Cell source:

other: EpiDerm (EPI-200)

Justification for test system used:

The test material is applied topically to a three dimensional human skin model. The skin corrosion test refers to the production of irreversible tissue damage in the skin following the application of a test material on a human skin model. The model allows identification of corrosive chemical substances and mixtures.

Vehicle:

water

Details on test system:

RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm, Epi-200-Kit. The EpiDerm tissue consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multi-layered, highly differenciated model of the human epidermis.
- Tissue vendor: MatTek Corporation in Ashland, USA
- Tissue batch number(s): 15650
- Delivery date: 19 Oct 2011
- Date of initiation of testing: 21 Oct 2011

TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 °C

REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: thoroughly rinsed with phosphate buffered saline (PBS) and blotted with sterile cellulose tissue

MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1mg/mL
- Incubation time: 3 h
- Wavelength: 570 nm

NUMBER OF REPLICATE TISSUES: 2

NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 2

PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is less than 50%, or if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15%.]
- The test substance is considered to be non-corrosive to skin if the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15%.

Control samples:

yes, concurrent negative control

yes, concurrent vehicle

Amount/concentration applied:

In average 25.6 mg

Duration of treatment / exposure:

3 minutes / 1 h

Number of replicates:

2

Irritation / corrosion parameter:

other: relative absorbance / optical density (OD)

Remarks:

mean value of 2 tissues

Run / experiment:

3 minutes

Value:

2.103

Vehicle controls validity:

valid

Negative controls validity:

not applicable

Positive controls validity:

valid

Irritation / corrosion parameter:

other: relative absorbance / optical density (OD)

Remarks:

mean value of 2 tissues

Run / experiment:

1 h

Value:

0.408

Vehicle controls validity:

valid

Negative controls validity:

not applicable

Positive controls validity:

valid

Other effects / acceptance of results:

ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The criterion for optical density of the negative control (> 0.8) was fulfilled: optical density was 2.109 (3 minutes) and 1.855 (1 h).
- Acceptance criteria met for positive control: The positive control showed a clear corrosive effect: the value of the 3 minutes experiment was 21.5% and the value of the 1 h experiment was 14.7%.
- Acceptance criteria met for variability between replicate measurements: Values for negative control and for positive control were within the range of historical data of the test facility.

The test item is considered not corrosive since the test item fulfilled the criteria given for non corrosive substances which are:

> 50% of negative control of Formazan production after 3 min. incubation time

> 15% of negative control of Formazan production after 1 h incubation time

Interpretation of results:

other: not corrosive

Conclusions:

There is regulatory acceptance in the EU that a substance can be considered corrosive (Skin Corrosive Cat. 1, 1A, 1B/C) based on a positive result in the Reconstructed human epidermis test method (in vitro skin corrosion). A negative in vitro corrosivity response is not conclusive with respect to non-classification or classification as a skin irritant and therefore requires further evaluation and/or data generation.

Reference 2

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

29 February - 2 March 2012

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:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

National Institute for Quality and Organizational Development in Healthcare and Medicines, Budapest, Hungary

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Cell source:

other: EpiSkin Small Model (EpiSkin SM)

Justification for test system used:

The EPISKIN model has been validated for irritation testing in an international trial; it is considered to be suitable for this study.

Vehicle:

unchanged (no vehicle)

Details on test system:

RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiSkin SM
- Model vendor: SKINETHIC Laboratories, France
- Tissue batch number: 12-EKIN-009
- Expiry date: 5 March 2012
- Date of initiation of testing: 29 Feb 2012

TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 °C
- Temperature of post-treatment incubation: 37 °C

REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: rinsed thoroughly with phosphate buffered saline
- Time after start of exposure: 15 min
- Post- incubation procedure: After rinsing the tzhe units are replaced into the plate wells with fresh pre-warmed maintenance medium (2ml/well) below them and the incubated for another 42h (+/-1h) at 37°C with 5% CO2.

MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 3 mg/mL
- Incubation time: 3 h
- Wavelength: 570 nm

NUMBER OF REPLICATE TISSUES: 3

NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1

PREDICTION MODEL
- The test substance is considered to be irritating to skin if the mean relative viability after 15 minutes exposure and 42 h post incubation is less or equal to 50% of the negative control

- The test substance is considered to be not irritating to skin if the mean relative viability after 15 minutes exposure and 42 h post incubation is greater than 50% of the negative control

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

The test item is a highly viscous material therefore exact weighting of treatment volume was not performed.

Duration of treatment / exposure:

15 minutes

Duration of post-treatment incubation (if applicable):

42 h

Number of replicates:

3

Irritation / corrosion parameter:

% tissue viability

Remarks:

mean value of 3 tissues

Run / experiment:

15 minutes / 42 h post-treatment incubation

Value:

80

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

- OTHER EFFECTS:
- Direct-MTT reduction: No colour change was observed after 3 h of incubation. The test material did not interact with the MTT.
- Colour interference with MTT: The intrinsic colour of test item is yellow to brown, however in low amount (such as treatment amount) it was observed as clear colourless and therefore not able to stain the tissue and lead to a false estimate of viability. In addition the test item showed no ability to become coloured in contact with water.

ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The mean optical density (OD) value of the three negative control tissues was 1.211.
- Acceptance criteria met for positive control: The positive control result showed 10% viability.
- Acceptance criteria met for variability between replicate measurements: Each standard deviation value (SD) of the % viability was below 18.

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.

Conclusions:

The results in this in - vitro skin irritation test by using the Episkin model indicates that the test item dermosoft decalact is not irritant according to the criteria of the CLP Regulation (EC) No. 1272/2008.

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

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10 - 29 February 2012

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 Ocular Corrosives and Severe Irritants)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, Kaiser-Friedrich-Str. 7, 55116 Mainz, Germany

Species:

cattle

Strain:

not specified

Details on test animals or tissues and environmental conditions:

SOURCE OF COLLECTED EYES
- Source: Slaughterhouse Muller Fleisch GmbH, Enzstr. 2.4, 75217 Birkenfeld, Germany
- Characteristics of donor animals (e.g. age, sex, weight): The cattle were between 12 and 60 months old.
- Storage, temperature and transport conditions of ocular tissue (e.g. transport time, transport media and temperature, and other conditions): The eyes were transported to the test facility in Hank's balanced salt solution (supplemented with antibiotics). Then, the corneas were dissected and incubated in medium at 32 ± 1 °C in an incubation chamber for 1 h.
- Time interval prior to initiating testing: Fresh bovine eyes were obtained on the day of the test.
- Indication of any antibiotics used: 0.01% streptomycin and 0.01% penicillin

Vehicle:

physiological saline

Remarks:

CAS no: 7647-14-5

Controls:

yes, concurrent vehicle

yes, concurrent positive control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 µl
- Concentration (if solution): 10% solution diluted in 0.9% sodium chloride solution

VEHICLE
- Amount(s) applied (volume or weight with unit): 675 µl
- Concentration (if solution): 0.9% solution of sodium chloride

Duration of treatment / exposure:

10 minutes

Duration of post- treatment incubation (in vitro):

2 h at 32°C.

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After exposure period (10 min) the corneas are rinsed with cMEM (complete Minimum Essential Medium) with phenol red and final rinsed with cMEM without phenol red, the anteriour chamber was filled with cMEM without phenol red, and the corneas were stored for additional 2 h at 32°C
- Time after start of exposure: Washing was done 10 min after an exposure period of 10 minutes.

SCORING SYSTEM: Calculation of in-vitro-irritancy score (IVIS)

TOOL USED TO ASSESS SCORE: Change in opacity of the corneas was determined based on change in absorption at 570 nm using a spectral photometer .

Irritation parameter:

in vitro irritation score

Run / experiment:

10 min

Value:

40.308

Other effects / acceptance of results:

Mean IVIS score for the test item (10% solution) was 46.308. According to OECD 437 (2009) a substance of IVIS < 55.1 may be considered as non - corrosive resp. not severely irritant.

Interpretation of results:

other: not corrosive

Conclusions:

There is regulatory acceptance in the EU that a substance can be considered corrosive (Eye Corrosive Cat. 1) based on a positive result in the Bovine corneal opacity and permeability test method. A result for which no prediction can be made is not conclusive with respect to non-classification or classification as an eye irritant and therefore requires further evaluation and/or data generation.

Reference 2

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 - 16 Jan 2020

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)

Version / remarks:

adopted in 2019

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

human

Strain:

other: EpiOcularTM, reconstructed three-dimensional human corneal epithelium

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent vehicle

yes, concurrent positive control

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 53.8 and 51.0 mg was applied directly on top of the skin tissues.

NEGATIVE CONTROL:
- Amount applied: 50 µL

POSITIVE CONTROL:
- Amount applied: 50 µL

Duration of treatment / exposure:

6 h at 37 ± 1 °C

Duration of post- treatment incubation (in vitro):

18 h at 37 ± 1 °C

Number of animals or in vitro replicates:

2 tissues for each treatment and control group

Details on study design:

DETAILS OF THE TEST PROCEDURE USED
The EpiOcular™ Eye Irritation Test (EIT) consists of a topical exposure of the neat test item to a human reconstructed cornea model followed by a cell viability test. Cell viability is measured by dehydrogenase conversion of MTT [3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide], present in cell mitochondria, into a blue formazan salt that is quantitatively measured after extraction from tissues. The percent reduction of cell viability in comparison of untreated negative controls is used to predict eye irritation potential.

RHCE TISSUE CONSTRUCT
- Model used: EPI-200 (MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia)
- Tissue Batch number: 30842

FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: The quality of the EpiOcular™ tissues was assessed via MTT cytotoxicity assay. The determined OD (540-570 nm) was 1.412 ± 0.033 and fell in the accepted range of 1.0 - 3.0.
- Barrier function: The barrier function was evaluated by determination of the exposure time required to reduce tissue viability by 50% (ET-50) upon treatment with 100 µL of 0.3% Triton X-100. The ET-50 value was 5.76 hours fits to the acceptance criteria of 4.77 – 8.2 hours.
- Contamination: The cells used to produce the EpiOcularTM tissue were screened for the presence of viruses, bacteria, yeast and other fungi. No contamination was detected. Tissue sterility was confirmed by long-term incubation with antibiotic and antimycotic free culture.

DOSES OF TEST CHEMICAL AND CONTROL SUBSTANCES:
TEST CHEMICAL: 53.8 and 51.0 mg
NEGATIVE CONTROL: 50 µL
POSITIVE CONTROL: 50 µL

DURATION AND TEMPERATURE
- EXPOSURE: 6 h at 37 ± 1 °C
- POST-EXPOSURE IMMERSION: 25 min at room temperature
- POST-EXPOSURE INCUBATION: 18 h at 37 ± 1 °C

REMOVAL OF TEST MATERIAL AND CONTROLS: At the end of the exposure time, the tissues were removed from the plates and rinsed thoroughly with Dulbecco’s phosphate buffered saline (DPBS).

INDICATION OF CONTROLS USED FOR DIRECT MTT-REDUCERS AND/OR COLOURING TEST CHEMICALS:
The test item was checked for color interference in a pre-experiment. The test item was added to isopropanol and incubated on an orbital shaker for 2 h at room temperature. After subtraction of the mean OD for isopropanol, the mean OD of the test item solution was -0.0010 (≤ 0.08). Therefore, it was concluded that the test item did not induce color interference and the main test was performed without colorant controls.
In addition, the test item was tested for the ability of direct MTT reduction in a pre-experiment. The test item was added to MTT solution and incubated in the dark for 3 h at 37 ± 1 °C. The MTT solution did not change its colour; therefore, direct MTT reduction had not taken place, and no data correction was necessary.

MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 165 min at 37 ± 1 °C
- Spectrophotometer: Anthos Reader 2010 Flexi (Anthos Microsysteme GmbH)
- Wavelength: 570 nm

EVALUATION CRITERIA
The test substance was considered to be not irritating to eye if the tissue viability after exposure and post-exposure incubation is > 60% relative to the negative control treated tissue.
The test chemical was identified as “no prediction can be made” if the mean percent tissue viability after exposure and post-exposure incubation was ≤ 60% relative to the negative control treated tissue.

TEST ACCEPTANCE CRITERIA
- Negative control: The mean absolute OD 570 nm of the two tissues is between 0.8 and 2.5.
- Positive control: The mean relative tissue viability is < 50% of the negative control viability.
- Relative tissue viability difference of replicate tissues is < 20%.

REFERENCE TO HISTORICAL DATA OF THE RHCE TISSUE CONSTRUCT: Please refer to Table 1 under "Any other information on materials and methods incl. tables".

Irritation parameter:

other: tissue viability

Remarks:

(mean value of 2 tissues)

Run / experiment:

6 h exposure

Value:

1.7

Vehicle controls validity:

valid

Negative controls validity:

not examined

Positive controls validity:

valid

Other effects / acceptance of results:

DEMONSTRATION OF TECHNICAL PROFICIENCY:
The validity of the EpiOcularTM test at the testing facitlity was demonstrated in a proficiency study. For this purpose 15 proficiency chemicals (indicated by the OECD guideline 492) were tested. All 15 proficiency chemicals were correctly categorised.

- Acceptance criteria met for negative control: The mean OD of the tissue replicates treated with the negative control was ≥ 0.8 and ≤ 2.8 (1.790) and fell within the range of the laboratories historical solvent control data (1.652 ± 0.247, range 1.047 - 2.340)
- Acceptance criteria met for positive control: The mean viability of the tissue replicates treated with the positive control was < 50% compared to the negative control (27.5%) and fell within the range of the laboratories historical solvent control data (34.8 ± 7.0%, range 21.1 - 53.9%)
- Relative tissue viability difference of replicate tissues was < 20% (values between 0.5 and 3.1%).

Table 2: Mean tissue viabilites obtained in the EpiOcular test

	Mean Absorbance		Tissue Viability
	Tissue 1	Tissue 2	Tissue 1	Tissue 2	Mean
Solvent control	1.818	1.762			100%
Test item	0.035	0.025	1.9	1.4	1.70%
Positive control	0.518	0.464	28.9	25.9	27.40%

Interpretation of results:

other: eye irritant or inducing serious eye damage

Conclusions:

The potential of the test substance to induce serious eye irritation was assessed using reconstructed human eithelial cornea like epithelium (RhCE). The mean tissue viability of RhEC tissue exposed to the test item was 1.7% compared to the negative control. Hence, the mean corrected cell viability value was below the cut-off percentage cell viability value that distinguishes irritant from non-irritant test items of ≤ 60%. Under the conditions of the conducted test, the test substance is considered to possess an irritating potential towards human cornea in the EpiOcular™ model, but the result is not conclusive with respect to classification of the test substance as eye irritant (Eye Irritant Cat. 2) or serious eye damage (Eye Damage Cat. 1) and therefore requires further evaluation and/or data generation.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation / corrosion

The potential for inducing corrosive effects to skin of fatty acids, C10-12, esters with polylactic acid, sodium salts (Dermosoft decalact, CAS No. 1312021-45-6, EC No. 700-937-1) has been investigated in vitro in the human skin model test according to OECD guideline 431 observing GLP provisions (Paulus  , 2012). Two tissues of the human skin model EPIDEREM were treated with the test item for 3 min and 1 h, respectively. In average, 25.6 mg of the test item were applied to each tissue and spread to match the tissue size. Deionised water was used as negative control and KOH (8 mol/L) was used as positive control. After treatment with the negative control the absorbance values were well above the required acceptability criterion for both treatment intervals thus showing the quality of the tissues. The positive control showed clear corrosive effects for both treatment intervals. After 3 min treatment with the test item, the relative absorbance values were reduced to 99.7%.  This value is well above the threshold for corrosion potential (50%). After 1 h treatment, relative absorbance values were reduced to 22% . This value, too, is above the threshold for corrosion potential (15%). Therefore, the test item is considered as not corrosive in the human skin model test.

In order to conclude on the hazard assessment and to derive the classification and labelling of Dermosoft decalact with respect to skin irritation, the reconstructed human epidermis test method according to OECD guideline 439 was performed. The study was performed under GLP conditions (Agh, 2012  ). Disks of EPISKIN (three units / chemical) were treated with the test item and incubated for 15 min at room temperature. Exposure of the test material was terminated by rinsing with phosphate buffered saline (PBS) solution. Epidermis units were then incubated at 37 °C for 42 h in an incubator with 5% CO2. The viability of each disk was assessed by incubating the tissues for 3 h with MTT solution at 37 °C in 5% CO2 protected from light. The formazan precipitated was then extracted using acidified isopropanol and quantified spectrophotometrically. Sodium dodecyl sulphate (5% aq.) and PBS treated epidermis were used as positive and negative controls, respectively. For each treated tissue viability was expressed as a percentage relative to negative control. A test item is considered to be irritant to skin, if the mean relative viability after 15 min exposure and 42 h post incubation is ≤ 50% of the negative control. The test item did not show significantly reduced cell viability in comparison to the negative control. All test item results were above 50% of the mean negative control value. Positive and negative controls showed the expected cell viability values within acceptable limits. The experiment was considered to be valid. In the in vitro skin irritation test using the EPISKIN model the results indicated that the test item is not irritating.  

The results of the in vitro skin irritation and corrosion studies are further supported by two human repeat insult patch tests (HRIPT) for the evaluation of skin irritation and skin sensitisation with 25% (Talsene, 2012a) and 6% solution (Talsene, 2012b) of the registered substance in glycerol which both revealed no indication for skin irritation.

Eye irritation / serious eye damage

The ability of fatty acids, C10-12, esters with polylactic acid, sodium salts (Dermosoft decalact, CAS No. 1312021-45-6, EC No. 700-937-1) to induce serious eye damage was tested using the bovine corneal opacity and permeability test method (BCOP) according to OECD guideline 437 and under GLP conditions (Andres, 2012 ). Bovine corneas collected from slaughtered cattle which were be­ tween 12 and 60 months old were used in the study. The test item was brought onto the cornea of a bovine eye which had been incubated with complete minimum essential medium (cMEM) without Phenol red at 32 ± 1 °C for 1 h and whose opacity had been measured. The test item was incubated on the cornea for 10 min at 32 ± 1 °C. After removal of the test item and a 2 h post-incubation period, opacity and permeability values were measured. Physiological sodium chloride solution was used as negative control. The negative control showed no irritating effect on the cornea. 10% sodium hydroxide solution was used as positive control. The positive control induced a severe irritation on the cornea. The test item showed moderate severe effects on the cornea of the bovine eye. The in vitro irritancy score (IVIS) was calculated to be 44.683. According to OECD guideline 437, a substance that induces an IVIS of 55.1 is defined as a corrosive or severe irritant. Therefore, the test item is considered not to induce serious eye damage.

In order to conclude on the eye irritating properties of Dermosoft decalact, a study according to OECD guideline 492 (EpiOcular) under GLP conditions was performed (Geitlinger,  2020). The test item was applied to a three-‭‬dimensional human cornea tissue model in duplicate for an exposure time of 6 h.‬ After treatment, the substance was rinsed from the tissue. Cell viability of the tissues was evaluated by addition of MTT, which can be reduced to a formazan. The formazan production was evaluated by measuring the optical density (OD) of the resulting solution. Demineralised water was used as negative control and methyl acetate served as positive control. The controls showed the expected results, thus validating the assay. The variation within tissue replicates of the controls and the test item was acceptable. After treatment with the test item, the mean value of relative tissue viability was 1.7%. This value is below the threshold for eye irritation potential (60%). Test items that induce values below the threshold are either eye irritant or inducing serious eye damage. Under the conditions of the test, the test substance is considered either eye irritant or inducing serious eye damage.‬‬‬

Conclusion on eye irritation

Since Dermosoft decalact was tested to be not corrosive in the BCOP assay (OECD guideline 437) and either corrosive or irritant in the EpiOcular test (OECD guideline 492), it is concluded that it is irritating to eyes.

Justification for classification or non-classification

The available data on skin irritation obtained with fatty acids, C10-12, esters with polylactic acid, sodium salts (Dermosoft decalact, CAS No. 1312021-45-6, EC No. 700-937-1) do not meet the criteria for classification according to Regulation (EC) No. 1272/2008 (CLP), and are therefore conclusive but not sufficient for classification.

The available data on eye irritation obtained with fatty acids, C10-12, esters with polylactic acid, sodium salts (Dermosoft decalact, CAS No. 1312021-45-6, EC No. 700-937-1) do meet the classification criteria as Eye Irrit. 2 (H319) according to Regulation (EC) No. 1272/2008.