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 401 and GLP study, the LD 50 (oral, rat) was > 5 mL/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1999

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

5 ml/kg instead of 2g/kg

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

5 males and 5 females

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

5 ml/kg

No. of animals per sex per dose:

5

Control animals:

no

Statistics:

no anormal clinical sign

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 mL/kg bw

Based on:

test mat.

Mortality:

no

Clinical signs:

other: no

Interpretation of results:

GHS criteria not met

Remarks:

Criteria used for interpretation of results: OECD GHS

Conclusions:

the results in the mentioned study is: LD 50 (rat) >5ml/kg

Executive summary:

The oral administration of Sophorolipids in rats up to 5ml/kg followed of an observational period of 14days allow to conclude:

- no mortality

-no clinical signs

-normal body weight increase in animals

- no mascroscopics findings

herewith the oral LD 50 in the test conditions is >5ml/kg bw

we conclude the substance is not toxic.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 5 000 mg/kg bw

Quality of whole database:

OECD 401 and GLP study

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

exposure considerations

Justification for data waiving:

the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation)

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Given the high value of LD50, no classification is warranted for acute oral toxicity.