Reaction products of Soya and Linseed Oil Fatty Acids with Bisphenol A diglycidylether

Endpoint summary

Description of key information

skin corrosion: not corrosive (OECD TG 431): relative tissue viability 102% (3 min exposure) and 108% (1 h exposure)

skin irritation: not irritating (OECD TG 439): relative tissue viability 75%

eye irritation: not irritating (O)ECD TG 437): IVIS -1.4

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:

15 May 2018 - 10 July 2018

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)

Version / remarks:

29 July 2016

Deviations:

no

GLP compliance:

yes

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Justification for test system used:

Guideline Recommendation

Vehicle:

unchanged (no vehicle)

Details on test system:

RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™ Reconstructed Human Epidermis Model Kit
- Tissue batch number(s): 28356 and 28368

TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37.0 ± 1.0°C
- Temperature of post-treatment incubation (if applicable): 37.0 ± 1.0°C, 5.0 ± 0.5% CO2

REMOVAL OF TEST MATERIAL AND CONTROLS
After the exposure period, the tissues were washed with phosphate buffered saline (Invitrogen Corporation, Breda, The Netherlands) to remove residual test item. The skin inserts were carefully dried.

MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1.0 mg/mL
- Incubation time: 3 hours
- Spectrophotometer:Tecan Infinite M200 Pro microplate reader

NUMBER OF REPLICATE TISSUES: duplicates

CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- killed tissues
- Procedure used to prepare the killed tissues (if applicable): freeze killed
- No. of replicates : duplicates
- Method of calculation used: True viability is calculated as the difference in OD between the living test item treated tissues incubated with MTT Medium and the difference between the freeze-killed treated and untreated tissues.

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 positive control

Amount/concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 μL

NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 μL of sterile distilled water

POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 μL of 8.0 N Potassium Hydroxide

Duration of treatment / exposure:

3 minutes, 60 minutes

Duration of post-treatment incubation (if applicable):

3 hours

Number of replicates:

2

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

3 minute exposure

Value:

102

Negative controls validity:

valid

Positive controls validity:

valid

Remarks:

10%

Remarks on result:

other:

Remarks:

Not Corrosive

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

60 minute exposure

Value:

108

Negative controls validity:

valid

Positive controls validity:

valid

Remarks:

6.4%

Remarks on result:

other:

Remarks:

Not Corrosive

Other effects / acceptance of results:

Direct-MTT reduction: The MTT solution containing the test item did not turn blue/purple. This was taken to indicate the test item did not reduce MTT.
Colour interference with MTT: The solution containing the test item did not become colored. This was taken to indicate the test item did not have the potential to cause color interference

ACCEPTABILITY CRITERIA
The in vitro skin corrosion test was considered acceptable having met the following criteria:
a) The absolute mean OD570 of the two tissues of the negative control was 1.585 for 3 minute exposure and 1.710 for the 60 minute exposure. Both values were within the laboratory historical control data range.
b) The mean relative tissue viability following 1-hour exposure to the positive control
was 6.4%, a value of <15 % was required
c) In the range 20 - 100% viability, the Coefficient of Variation (CV) between tissue
replicates was less than or equal to 30%.
All results presented in the tables of the report are calculated using values as per the raw data
rounding procedure and may not be exactly reproduced from the individual data presented.

Mean Tissue Viability in thein vitroSkin Corrosion Test with Soya/Linseed Oil Fatty Acid-BADGE reaction product

	3-minute application viability (percentage of control)	1-hour application viability (percentage of control)
Negative control	100	100
Test item	102	108
Positive control	10	6.4

Interpretation of results:

other:

Remarks:

Not corrosive

Conclusions:

The test item was considered to be non-corrosive to the skin.

Executive summary:

The objective of this study was to evaluate Soya/Linseed Oil Fatty Acid-BADGE reaction product for its ability to induce skin corrosion on a human three dimensional epidermal model (EpiDerm (EPI-200)). The possible corrosive potential of Soya/Linseed Oil Fatty Acid-BADGE reaction product was tested through application of undiluted (50 µL) test item directly on top of the skin tissue for 3 minutes and 1 hour. The study procedures were based on the most recent OECD 430 guidelines.

 

The positive control had a mean relative tissue viability of 6.4% 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 23%,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 108%, 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.

Reference 2

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17 July 2018 to 20 July 2018

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)

Version / remarks:

updated 28 July 2015

Deviations:

no

GLP compliance:

yes

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Justification for test system used:

Guideline recommendation

Vehicle:

unchanged (no vehicle)

Details on test system:

RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPISKIN-SM
- Tissue batch number(s): 18-EKIN-029

TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature
- Temperature of post-treatment incubation (if applicable): 37.0 ± 1.0°C

REMOVAL OF TEST MATERIAL AND CONTROLS
The tissues were washed with phosphate buffered saline to remove residual test item. Due to the physical properties of the test item, it was difficult to remove from the cell culture inserts, and some residual test
item could still be left. After rinsing, the cell culture inserts were each dried carefully and moved to a new welL


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

NUMBER OF REPLICATE TISSUES: 3

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

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

25 μL Test item, Neg control, or Pos control

Duration of treatment / exposure:

15 ± 0.5 minutes

Duration of post-treatment incubation (if applicable):

42 hours at 37°C.

Number of replicates:

3

Irritation / corrosion parameter:

% tissue viability

Value:

75

Negative controls validity:

valid

Remarks:

The standard deviation value of the percentage viability of three tissues treated with the negative control was ≤ 23%, which was slightly above the acceptability criteria

Positive controls validity:

valid

Remarks:

The positive control had a mean cell viability after 15 ± 0.5 minutes exposure of 20%.

Other effects / acceptance of results:

Soya/Linseed Oil Fatty Acid-BADGE reaction product was checked for possible direct MTT reduction and color interference in the Skin corrosion test using EpiDerm as a skin model
(Test Facility Study No. 20151900). Because no color changes were observed it was concluded that Soya/Linseed Oil Fatty Acid-BADGE reaction product did not interact with the MTT endpoint.

DEMONSTRATION OF TECHNICAL PROFICIENCY:
ACCEPTANCE OF RESULTS:
- Acceptance criteria was considered satisfied for negative control: The mean OD570 for the negative control treated tissu es was 0.925 and the standard deviation value of the viability was 23%.

- Acceptance criteria was considered satisfied for positive control: The relative mean tissue viability for the positive control treated tissues was 20% relative to the negative control treated tissues and the standard deviation
value of the viability was 8.9%.

- Acceptance criteria was considered satisfied for variability between replicate measurements: The standard deviation calculated from individual tissue viabilities of the three identically test item treated tissues was 9.2%.
The absolute mean OD570 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 with the negative control was ≤ 23%, which was slightly above the acceptability criteria. The standard deviation value of the percentage viability of three tissues treated identically with either positive control or test item was 8.9%, indicating that the test system functioned properly.

Mean Tissue Viability in theIn VitroSkin Irritation Test with Soya/Linseed Oil Fatty Acid-BADGE reaction product

	Mean tissue viability (percentage of control)	Standard deviation (percentage)
Negative control	100	23
Soya/Linseed Oil Fatty Acid-BADGE reaction product	75	9.2
Positive control	20	8.9

 

Interpretation of results:

GHS criteria not met

Conclusions:

Soya/Linseed Oil Fatty Acid-BADGE reaction product 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.

Executive summary:

The objective of this study was to evaluate Soya/Linseed Oil Fatty Acid-BADGE reaction product 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 Soya/Linseed Oil Fatty Acid-BADGE reaction product was tested through topical application for 15 minutes.

The study procedures were based on the most recent OECD TG 439 and EC Guideline 440/2008.

Soya/Linseed Oil Fatty Acid-BADGE reaction product 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 Soya/Linseed Oil

Fatty Acid-BADGE reaction product compared to the negative control tissues was 75%. Since the mean relative tissue viability for Soya/Linseed Oil Fatty Acid-BADGE reaction

product was above 50% after 15 ± 0.5 minutes treatment Soya/Linseed Oil Fatty Acid-BADGE reaction product is considered to be non-irritant.

The positive control had a mean cell viability of 20% 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 with the negative control was ≤ 23%, which was slightly

above the acceptability criteria. The standard deviation value of the percentage viability of three tissues treated identically with either positive control or test

item was < 10%, indicating that the test system functioned properly.

In conclusion, Soya/Linseed Oil Fatty Acid-BADGE reaction product 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:

04 May 2018 to 15 May 2018

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)

Version / remarks:

adopted October 09, 2017).

Deviations:

no

GLP compliance:

yes

Species:

cattle

Details on test animals or tissues and environmental conditions:

Bovine eyes from young cattle were obtained from a local slaughterhouse where the eyes were excised by a slaughterhouse employee as
soon as possible after slaughter. Eyes were collected and transported in physiological saline in a suitable container under cooled conditions

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

Amount Applied:
0.75 ml of test item, positive control, or negative control

Duration of treatment / exposure:

10 +/- 1 minutes

Duration of post- treatment incubation (in vitro):

120 +/- 10 minutes

Number of animals or in vitro replicates:

3

Details on study design:

Preparation of Corneas
The eyes were checked for unacceptable defects, such as opacity, scratches, pigmentation and neovascularization by removing them from the physiological saline and holding them in the light. Those exhibiting defects were discarded.

The isolated corneas were stored in a petri dish with cMEM (Earle’s Minimum Essential Medium containing 1% (v/v) L-glutamine and 1% (v/v) Foetal Bovine Serum . The isolated corneas were mounted in a corneal holder (one cornea per holder) of BASF (Ludwigshafen, Germany) with the endothelial side against the O-ring of the posterior half of the holder.. The compartments of the corneal holder were filled with cMEM of 32 +/- 1C. The corneas were incubated for the minimum of 1 hour at 32 +/- degrees C.

Cornea Selection and Opacity Reading
After the incubation period, the medium was removed from both compartments and replaced with fresh cMEM. Opacity determinations were performed on each of the corneas using an opacitometer (BASF-OP3.0, BASF, Ludwigshafen, Germany). The opacity of each cornea was read against a cMEM filled chamber, and the initial opacity reading thus determined was recorded. Corneas that had an initial opacity reading higher than 7 were not used. Three corneas were selected at random for each treatment group.

Treatment of Corneas and Opacity Measurements
The medium from the anterior compartment was removed and 750 ul of either the negative control, positive control (Ethanol) or 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 +/- degrees C. After the incubation the solutions were removed and the epithelium was washed with MEM with phenol red and thereafter with cMEM. Possible pH effects of the test item on the corneas were recorded. The medium in the posterior compartment was removed and both compartments were refilled with fresh cMEM. Subsequently the corneas were incubated for 120 +/- 10 minutes at 32 +/- 1 degrees C. After the completion of the incubation period opacity determination was performed. Each cornea was inspected visually for dissimilar opacity patterns.

Following the final opacity measurement, permeability of the cornea to Na-fluorescein was evaluated. The medium of both compartments (anterior compartment first) was removed. The posterior compartment was refilled with fresh cMEM. The anterior compartment was filled with 1 mL of 4 mg Na-fluorescein/mL cMEM solution. The holders were slightly rotated, with the corneas maintained in a horizontal position, to ensure uniform distribution of the sodium-fluorescein solution over the entire cornea. Corneas were incubated in a horizontal position for 90 +/- 5 minutes at 32 +/- 1 degrees C.

After the incubation period, the medium in the posterior compartment of each holder was removed and placed into a sampling tube labelled according to holder number. 360 μL of the medium from each sampling tube was transferred to a 96-well plate. The optical density at 490 nm (OD490) of each sampling tube was measured in triplicate using a microplate reader (TECAN Infinite® M200 Pro Plate Reader). Any OD490 that was 1.500 or higher was diluted to bring the OD490 into the acceptable range (linearity up to OD490 of 1.500 was verified before the start of the experiment). OD490 values of less than 1.500 were used in the permeability calculation. The mean OD490 for each treatment was calculated using cMEM corrected OD490 values. If a dilution has been performed, the OD490 of each reading of the positive control and the test item was corrected for the mean negative control OD490 before the dilution factor was applied to the reading.

Irritation parameter:

in vitro irritation score

Run / experiment:

Mean in vitro irritancy score of -1.4

Value:

> -2.2 - < -0.8

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Treatment	Mean Opacity^1	Mean Permeability^1	Mean In Vitro Irritation Score^1, 2
Negative control	1.8	-0.016	1.6
Positive control (Ethanol)	16	1.625	40
Soya/Linseed Oil Fatty Acid-BADGE reaction product	-1.7	0.022	-1.4

1   Calculated using the negative control mean opacity and mean permeability values for the positive control and test item.

2   In vitroirritancy score (IVIS) = mean opacity value + (15 x mean OD₄₉₀value).

Interpretation of results:

GHS criteria not met

Conclusions:

In conclusion, since Soya/Linseed Oil Fatty Acid-BADGE reaction product induced an IVIS ≤ 3, 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 Soya/Linseed Oil Fatty Acid-BADGE reaction product as measured by its ability to induce opacity and increase

permeability in an isolated bovine cornea using the Bovine Corneal Opacity and Permeabilitytest (BCOP test).

The study procedures were based on the most recent OECD guideline 437. 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.

Soya/Linseed Oil Fatty Acid-BADGE reaction product did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of -1.4 after 10 minutes of

treatment.

In conclusion, since Soya/Linseed Oil Fatty Acid-BADGE reaction product 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

Skin irritation

The objective of this study was to evaluate Soya/Linseed Oil Fatty Acid-BADGE reaction product for its ability to induce skin corrosion on a human three dimensional epidermal model (EpiDerm (EPI-200)). The possible corrosive potential of Soya/Linseed Oil Fatty Acid-BADGE reaction product was tested through application of undiluted (50 µL) test item directly on top of the skin tissue for 3 minutes and 1 hour. The study procedures were based on the most recent OECD 430 guidelines.

The positive control had a mean relative tissue viability of 6.4% 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 23%, 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 108%, 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.

 

The objective of this study was to evaluate Soya/Linseed Oil Fatty Acid-BADGE reaction product 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 Soya/Linseed Oil Fatty Acid-BADGE reaction product was tested through topical application for 15 minutes.

The study procedures were based on the most recent OECD TG 439 and EC Guideline 440/2008.

Soya/Linseed Oil Fatty Acid-BADGE reaction product 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 Soya/Linseed Oil

Fatty Acid-BADGE reaction product compared to the negative control tissues was 75%. Since the mean relative tissue viability for Soya/Linseed Oil Fatty Acid-BADGE reaction

product was above 50% after 15 ± 0.5 minutes treatment Soya/Linseed Oil Fatty Acid-BADGE reaction product is considered to be non-irritant.

The positive control had a mean cell viability of 20% 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 with the negative control was ≤ 23%, which was slightly

above the acceptability criteria. The standard deviation value of the percentage viability of three tissues treated identically with either positive control or test

item was < 10%, indicating that the test system functioned properly.

 

In conclusion, Soya/Linseed Oil Fatty Acid-BADGE reaction product 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.

 

 

Eye irritation

The objective of this study was to evaluate the eye hazard potential of Soya/Linseed Oil Fatty Acid-BADGE reaction product 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).

The study procedures were based on the most recent OECD guideline 437. 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.

Soya/Linseed Oil Fatty Acid-BADGE reaction product did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of -1.4 after 10 minutes of

treatment.

 

In conclusion, since Soya/Linseed Oil Fatty Acid-BADGE reaction product induced an IVIS ≤ 3, no classification is required for eye irritation or serious eye damage.

 

Respiratory irritation

No data on the respiratory irritation of Soya/Linseed Oil Fatty Acid-BADGE reaction product are available.

 

There are no data gaps for the endpoint irritation/corrosion. No human information is available for this endpoint. However, there is no reason to believe that these results would not be applicable to humans.

Justification for classification or non-classification

Skin irritation

Based on reliable, adequate and relevant data, Soya/Linseed Oil Fatty Acid-BADGE reaction product does not need to be classified for skin irritation according to regulation (EC) 1272/2008.

 

Eye irritation

Based on reliable, adequate and relevant data, Soya/Linseed Oil Fatty Acid-BADGE reaction product does not need to be classified for eye irritation according to regulation (EC) 1272/2008.