complex mixture from biological origin

Endpoint summary

Description of key information

No substance specific data on skin irritation/corrosion is available. Therefore, data from a suitable read-across partner was used. Details and justification of read-across is summarized in section 13 of IUCLID.

Based on the results of two available studies conducted according to OECD 439 and draft OECD guideline for skin irritation, the substance is not considered to be skin irritant.

Eye irritation was assessed in vitro for the test item and several related substances (OECD 492 & OECD 437). Furthermore, in vivo data on eye irritation are available for two related substances. Based on the results of these studies using a weight-of-evidence approach, the target substance is considered to be a eye irritant, but not corrosive to the eye. 

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:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

For details and justification of read-across please refer to the report attached in section 13 of IUCLID.

Reason / purpose for cross-reference:

read-across source

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

TEST ITEM (mean of 3 replicates)

Value:

ca. 113.2

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

positive control (mean of 3 replicates)

Value:

ca. 29

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

not applicable

Remarks on result:

positive indication of irritation

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

negative control (mean of 3 replicates)

Value:

100

Vehicle controls validity:

not applicable

Negative controls validity:

not applicable

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Other effects / acceptance of results:

- OTHER EFFECTS:
- Visible damage on test system: not reported
- Direct MTT reduction: no
- Colour interference with MTT: no
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance is not irritating in the in vitro skin irritation test under the experimental conditions described in this report.

Executive summary:

In an in vitro skin irritation study performed in accordance with OECD draft proposal for a new guideline “In vitro Skin Irritation: Reconstructed Human Epidermis (RhE) Test Method”, the test substance “Sophorolipids: fermentation products of glucose and fatty acids, C18-unsatd., esters with glycerol with yeast Candida Bombicola, partially hydrolysed” was applied neat to reconstructed human epidermis for an exposure period of 15 minutes. The number of replicate tissues was three. After 15 minutes exposure the tissues were washed with phosphate buffered saline. Subsequently the tissue constructs were incubated for 42 h at 37 °C. Afterwards, tissues were placed in MTT working solution and incubated at 37 °C, 5 % CO₂, for approximately 3 h. MTT was reduced by viable cells into blue formazan crystals which were extracted and transferred for 570-nm optical density reading in duplicate. Relative cell viability for each test compound was calculated as the OD570 ratio to negative control.

The positive (5 % SDS) and negative (PBS) control gave responses that were within the acceptance criteria and as such demonstrated the validity of the study.

The relative mean tissue viability obtained after 15 minutes treatment with the test substance compared to the negative control tissues was 113.2 %. Since the mean relative tissue viability for the test substance was above 50 %, the test substance “Sophorolipids: fermentation products of glucose and fatty acids, C18-unsatd., esters with glycerol with yeast Candida Bombicola, partially hydrolysed” is identified to be not irritating.

This information is used in a read-across approach in the assessment of the target substance. For justification of read-across please refer to the attached read-across report (see IUCLID section 13).

Reference 2

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

For details and justification of read-across please refer to the report attached in section 13 of IUCLID.

Reason / purpose for cross-reference:

read-across source

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

mean of triplicates

Value:

94.1

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Other effects / acceptance of results:

- OTHER EFFECTS:
- Colour interference with MTT: no

ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes

Interpretation of results:

GHS criteria not met

Conclusions:

In this in vitro skin irritation study (OECD 439), the test item is not considered to be irritant to the skin.

Executive summary:

In an in vitro dermal irritation study conducted according to OECD guideline 439, the EpiDerm™-Model (EPI-200-SIT & EPI-212 SIT) was topically exposed to the test item "Sophorolipids: fermentation products of yeast Torulopsis (Candida) Bombicola, C16-C18, lactone form" for 60 min and 46 h post incubation period. Irritant potential of the test item was predicted from the relative mean tissue viabilities obtained compared to the corresponding negative control tissues concurrently treated with DPBS. The mean relative tissue viability of the test item (% negative control) was greater than 50% (94.1%). Based on this result, the test item is considered to be non-irritating to the skin and no classification according to CLP Regulation 1272/2008 is warranted.

This information is used in a read-across approach in the assessment of the target substance. For justification of read-across please refer to the attached read-across report (see IUCLID section 13).

Reference 3

Endpoint:

skin irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Justification for type of information:

The substance described by Ikeda et al. (1986), polyoxypropylene (12) [2'-0-beta-D-glucopyranosyl-beta-D-glucopyranosyl) oxy-] fatty acid ester-], is a glycolipide derivative and an acetylated form of the sophorolipids. The underlying generic structure of the main component of the target substance is identical to the source substance. Therefore, it is expected that these substances have similar physicochemical properties, and thus, there should be no significant differences in the absorption into the body and in the toxicity profile between source and target substance.

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

other: number of positive reactions on intact skin

Basis:

mean

Time point:

24 h

Score:

0

Remarks on result:

other: number of positive reactions: 0/10 animals

Irritation parameter:

other: number of positive reactions on intact skin

Basis:

mean

Time point:

48 h

Score:

0

Remarks on result:

other: number of positive reactions: 0/10 animals

Interpretation of results:

study cannot be used for classification

Conclusions:

No reactions for skin irritation was observed after 24 and 48 hours after treatment for the test substance on intact and abraded skin.

Executive summary:

In an in vivo skin irritation study, 10 Hartley guinea pigs were exposed to Sophorolipid (C16-C18) (50 % w/w in petrolatum) for 24 and 48 hours on intact and abraded skin. Animals were observed for 48 hours. Erythema and edema was scored and the number of positive reactions were counted. In this study, reactions on skin irritation was observed in none of the animals. The test item is not considered to have skin irritating properties.

This information is used in a read-across approach in the assessment of the target substance.

The substance described by Ikeda et al. (1986), polyoxypropylene (12) [2'-0-beta-D-glucopyranosyl-beta-D-glucopyranosyl) oxy-] fatty acid ester-], is a glycolipide derivative and an acetylated form of the sophorolipids. The underlying generic structure of the main component of the target substance is identical to the source substance. Therefore, it is expected that these substances have similar physicochemical properties, and thus, there should be no significnat differences in the absorption into the body and in the toxicity profile between source and target substance.

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:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Justification for type of information:

This information is used in a read-across approach in the assessment of the target substance.
For justification of read-across please refer to the attached read-across report (see IUCLID section 13).

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

in vitro irritation score

Run / experiment:

mean of 3

Value:

10

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

OTHER EFFECTS:
A pH effect of the test material was observed on the rinsing medium, the corneas were rinsed until no color change of the medium was observed.

ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes, 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. Altough the negative control treated corneas were translucent, all results are within the acceptability range therefore this has no impact on the study result.
- Acceptance criteria met for positive control: yes, The mean in vitro irritancy score of the positive control (Ethanol) was 51 and within two standard deviations of the current historical positive control mean

Interpretation of results:

study cannot be used for classification

Remarks:

further information is required for classification according to IATA guidance

Conclusions:

The test material induced ocular irritation through one endpoint (permeability), resulting in a mean in vitro irritancy score of 10 after 10 minutes of treatment. In conclusion, since PC-2021-999 induced an IVIS > 3 ≤ 55, no prediction on the classification can be made.

Executive summary:

In an in vitro eye irritation guideline study (bovine corneal opacity and permeability assay) according to OECD 437 under GLP conditions, 0.75 mL of a of “Sophorolipids: fermentation products of glucose and fatty acids, C18-unsatd., esters with glycerol with yeast Candida Bombicola, lactone intermediate” was applied on corneas for 10 min at 32 °C. The test was performed in triplicates.

Physiological saline was used as negative control, ethanol as positive control. Both controls confirmed the validity of the study.

The test material induced ocular irritation through one endpoint (permeability), resulting in a mean in vitro irritancy score of 10 after 10 minutes of treatment.

In conclusion, no prediction on the classification can be made.

This information is used in a read-across approach in the assessment of the target substance. For justification of read-across please refer to the attached read-across report (see IUCLID section 13).

Reference 2

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

2021-12-02 to 2021-12-10

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:

18 June 2019

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material:
Test article: R&D Line Lot Number: 251021Line

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing (e.g. warming, grinding): The test material was vortexed at maximum speed for 30 seconds, just prior testing

Species:

human

Details on test animals or tissues and environmental conditions:

The EpiOcular™ human cell construct (MatTek Corporation)

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

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

Duration of treatment / exposure:

30 ± 2 minutes

Duration of post- treatment incubation (in vitro):

120 ± 15 minutes

Number of animals or in vitro replicates:

2 inserts

Details on study design:

- Details of the test procedure used: The EpiOcular™epithelial model (MatTek Corporation)
- Doses of test chemical and control substances used: not stated
- Duration and temperature of exposure, post-exposure immersion and post-exposure incubation periods :

Article exposure: The tissues were then incubated at standard culture conditions (37 ± 1 °C, 5% CO2, 90 ± 10% humidity) for 30 ± 2 minutes.
Post-Soak: 12 ± 2 minute immersion incubation (Post-Soak) at room temperature
Post-incubation: The tissues were incubated for 120 ± 15 minutes at standard culture conditions minute immersion incubation (Post-Soak) at room temperature.

- Number of tissue replicates used per test chemical and controls :2
- Wavelength and band pass:570nm
- Description of the method used to quantify MTT formazan: A BioTek SOOTS Microplate Reader was used to determine the absorbance of each extract at 570 nm. With the absorbance of the negative control defined as 100%, the percent absorbencies of the articles were determined.
- Positive and negative control means and acceptance ranges based on historical data: yes
- Acceptable variability between tissue replicates for positive and negative controls: yes
- Acceptable variability between tissue replicates for the test chemical: yes

Irritation parameter:

mean percent tissue viability 

Run / experiment:

2 experiments

Value:

13.1

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: no prediction can be made (further information would be required for classification according to IATA guidance).

Substance	Mean of OD-570's	Deviation of OD-570's	Mean of Viability (%)	Deviation of Viability
Test itemR&D Line Lot Number: 251021Line (100%)	0.273	0.015	13.1	0.74
Negative control: Sterile, deionized water	2.088	0.013	100.0	0.61
Positive control: Methyl Acetate	0.754	0.277	36.1	13.28

Interpretation of results:

study cannot be used for classification

Remarks:

further information is required for classification according to IATA guidance

Conclusions:

The test item elicited a mean tissue viability of 13.1 % and as per MatTek' s protocol it is considered an irritant. As per OECD TG No. 492, the test item does not meet the criteria for "no category".

Executive summary:

In a primary eye irritation study conducted according to OECD 492 (EpiOcular™cornea epithelial model) 50 µL of the test item "Sophorolipids: fermentation products of glucose and fatty acids, C18 (unsaturated), glycerol esters with yeast Starmerella bombicola, hydrolysed", positive control methyl acetate and negative control water, were applied topically on the Epi Ocular™ tissue of 2 inserts for 30 ± 2 minutes. At the end of the treatment time, the articles were removed by extensively rinsing the tissues with DPBS and post-treatment incubation for 120 ± 15 minutes at standard culture conditions was performed. After the post-treatment incubation of 120 ± 15 minutes, the MTT assay was performed. 

Under the conditions of this test, the test item elicited a mean tissue viability of 13.1 % and as per MatTek' s protocol it is considered an irritant. As per OECD TG No. 492, the test item does not meet the criteria for "no category".

Reference 3

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Justification for type of information:

This information is used in a read-across approach in the assessment of the target substance.
For justification of read-across please refer to the attached read-across report (see IUCLID section 13).

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

in vitro irritation score

Run / experiment:

mean of 3 replicates

Value:

ca. 32.3

Vehicle controls validity:

valid

Negative controls validity:

not examined

Positive controls validity:

valid

Interpretation of results:

study cannot be used for classification

Remarks:

further information is required for classification according to IATA guidance

Conclusions:

The eye irritancy potential of the test substance was investigated in the bovine corneal opacity and permeability assay. The following mean in vitro irritation score was calculated: 32.3 ± 5.8. According to IVIS the test item is considered "moderate eye irritant". Acording to OECD 437 it is "not classified as an ocular corrosive or severe irritant".

Executive summary:

In an in vitro eye irritation guideline study (bovine corneal opacity and permeability assay) according to OECD 437 under GLP conditions, 0.75 mL of a 10 % solution of “Sophorolipids: fermentation products of glucose and fatty acids, C18-unsatd., esters with glycerol with yeast Candida Bombicola, partially hydrolysed” in physiological saline was applied on corneas for 10 min at 32 °C. The test was performed in triplicates.

Physiological saline was used as negative control, N,N-dimethylformamide as positive control. Both controls confirmed the validity of the study. In this study, the mean in vitro irritation score was 32.3 ± 5.8. According to IVIS the test item is considered "moderate eye irritant". Acording to OECD 437 it is "not classified as an ocular corrosive or severe irritant".

This information is used in a read-across approach in the assessment of the target substance. For justification of read-across please refer to the attached read-across report (see IUCLID section 13).

Reference 4

Endpoint:

eye irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Justification for type of information:

The substance described by Ikeda et al. (1986), polyoxypropylene (12) [2'-0-beta-D-glucopyranosyl-beta-D-glucopyranosyl) oxy-] fatty acid ester-], is a glycolipide derivative and an acetylated form of the sophorolipids. The underlying generic structure of the main component of the target substance is identical to the source substance. Therefore, it is expected that these substances have similar physicochemical properties, and thus, there should be no differences in the absorption into the body and in the toxicity profile between source and target substance.

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Interpretation of results:

GHS criteria not met

Conclusions:

In this study, the test item Sophorolipid (C16-C18) , did not show any reaction for eye irritation.

Executive summary:

In a primary eye irritation study, 0.1 mL of Sophorolipid (C16-C18) (50% w/w solution in water) was instilled into the conjunctival sac of the eye of 5 female White-Japanese rabbits for 168 hours without washing the eyes. Animals then were observed for 168 hours. Irritation was scored by the method of Draize after 1, 24, 48, 72 and 168 hours after treatment.

The test substance did not cause any reaction in the rabbit eyes. For ocular lesions, a score of 0 for each lesion in each animal was determined. In this study, the test substance is not an eye irritant.

This information is used in a read-across approach in the assessment of the target substance.

The substance described by Ikeda et al. (1986), polyoxypropylene (12) [2'-0-beta-D-glucopyranosyl-beta-D-glucopyranosyl) oxy-] fatty acid ester-], is a glycolipide derivative and an acetylated form of the sophorolipids. The underlying generic structure of the main component of the target substance is identical to the source substance. Therefore, it is expected that these substances have similar physicochemical properties, and thus, there should be no significant differences in the absorption into the body and in the toxicity profile between source and target substance.

Reference 5

Endpoint:

eye irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Justification for type of information:

For details and justification of read-across please refer to the report attached in section 13 of IUCLID.

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 168 hours

Remarks on result:

positive indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 168 hours

Remarks on result:

positive indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Interpretation of results:

GHS criteria not met

Conclusions:

In this study, the test item Sophorolipid, lactone form, did show mild conjunctivitis mainly composed of hyperemia and secretions, which were fully reversible within 168 hours. Based on these results, the test item is not considered to be a eye irritant.

Executive summary:

In a primary eye irritation study, 0.1 mL of Sophorolipid, lactone form (20% w/w solution in water) was instilled into the conjunctival sac of the eye of 3 female White-Japanese rabbits for 168 hours without washing the eyes. Animals then were observed for 168 hours. Irritation was scored by the method of Draize after 1, 24, 48, 72 and 168 hours after treatment.

The test substance did show mild conjunctivitis mainly composed of hyperemia and secretions, which were fully reversible within 168 hours. In this study, the test substance at 20% w/w is not an eye irritant based on GHS criteria.

This information is used in a read-across approach in the assessment of the target substance. For justification of read-across please refer to the attached read-across report (see IUCLID section 13). 

Reference 6

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Justification for type of information:

For details and justification of read-across please refer to the report attached in section 13 of IUCLID.

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

mean percent tissue viability 

Run / experiment:

2 experiments

Value:

2.4

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: no prediction can be made (further information would be required for classification according to IATA guidance).

Interpretation of results:

study cannot be used for classification

Remarks:

further information is required for classification according to IATA guidance

Conclusions:

Under the conditions of this test, the test item Sophorolipids: fermentation products of yeast Torulopsis (Candida) Bombicola, C16-C18, lactone form" , elicited a mean tissue viability of 2.4% and as per MatTek's protocol it is considered an irritant. As per OECD TG No. 492, the test item does not meet the criteria for "no category".

Executive summary:

In a primary eye irritation study conducted according to OECD 492 (EpiOcular™cornea epithelial model) 50 µL of the test substance "Sophorolipids: fermentation products of yeast Torulopsis (Candida) Bombicola, C16-C18, lactone form", positive control methyl acetate and negative control water, were applied topically on the Epi Ocular™ tissue of 2 inserts for 30 ± 2 minutes. At the end of the 30 ± 2 minutes treatment time, the articles were removed by extensively rinsing the tissues with DPBS and post-treatment incubation for 120 ± 15 minutes at standard culture conditions was performed. After the post-treatment incubation of 120 ± 15 minutes, the MTT assay was performed. 

Under the conditions of this test, the test item elicited a mean tissue viability of 2.4% and as per MatTek's protocol it is considered an irritant. As per OECD TG No. 492, the test item does not meet the criteria for "no category".

This information is used in a read-across approach in the assessment of the target substance. For justification of read-across please refer to the attached read-across report (see IUCLID section 13).

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The potential to induce skin irritation/corrosion of the test item was assayed in two in vitro studies conducted with related substances. Based on the results, the substance is not considered to be skin irritant. Classification according to the criteria set out in regulation (EC) No. 1272/2008 is not warranted.

For eye irritation, using a weight-of-evidence approach, the substance is not considered to be an ocular corrosive or severe irritant (OECD 437), but an irritant potential can be concluded based on the results of two OECD 492 studies. Together with in vivo data on structural related compounds and based on a Weight of Evidence approach, the test item is classified as irritating to the eyes (Cat. 2, H319).