Sophorolipids: fermentation products of glucose and rapeseed-oil fatty acids methyl esters with yeast Candida Bombicola

Endpoint summary

Description of key information

In an OECD 404 and GLP study, the substance was not skin irritating.

In an OECD 405 and GLP study, the substance was considered irritating for the eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

march 1993

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 ml of undiluted product per semi-occlusive patch

Duration of treatment / exposure:

4h

Observation period:

1h, 24h, 48h, 72h

Number of animals:

3

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 1

Max. score:

1

Reversibility:

fully reversible within: 24H

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 1

Max. score:

2

Reversibility:

fully reversible within: 24 H

Irritant / corrosive response data:

no reaction observed after 24h

Interpretation of results:

not irritating

Remarks:

Criteria used for interpretation of results: OECD GHS

Conclusions:

This substance is not skin irritating under the test conditions

Executive summary:

An erythema after 1h once the patch has been removed was observed. But this observation disapperared in the following checking times at 24, 48 and 72 H

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March 1993

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Vehicle:

unchanged (no vehicle)

Controls:

other: left eye of the same rabbit

Amount / concentration applied:

0.1 ml of undiluted product in the right eye

Duration of treatment / exposure:

eye closed 1s then after 1h the rabbit is back in the cage

Observation period (in vivo):

1h, 24h, 48h, 72h, then till 14 days

Number of animals or in vitro replicates:

3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 3

Max. score:

3

Reversibility:

fully reversible

Remarks:

within 14 days

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

24/48/72 h

Score:

>= 2.7 - <= 3

Max. score:

3

Reversibility:

fully reversible within: 14 days

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

>= 1 - <= 1.7

Max. score:

2

Reversibility:

fully reversible within: 10 days

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 9 days

Irritant / corrosive response data:

This substance is irritating for the rabbits eyes. their cornea is blessed during 48h. This effect has totally disappeared after 6 to 8 days.

Interpretation of results:

irritating

Remarks:

Criteria used for interpretation of results: OECD GHS

Conclusions:

This substance is considered irritating for eyes

Executive summary:

1h after instillation, the tested substance produced an important irritation on the conjunctiva producing redness and intense oedema.The mean values are calculated to be 3.

These reactions decreased after 1 week and completely dissapeared after 13 days. They appeared together with an important lacrimation that stay up to 5/6 days

A congestion in the iris is noted after 1h of contact, this reaction is fully reversible in the 3 rabbits after 1 week

The first 48h, the toal surface of the cornea of the 3 rabbits is covered. The total opacity is more important in the rabbit no 2002 and decrease after 72h to be fully reversible after 6/8 days

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Given the results from OECD 404 and 405 studies, no classification is warranted for skin irritation but a classification as Eye Irrit. 2 is established for eye irritation.