complex mixture from biological origin

Endpoint summary

Description of key information

No substance specific data on acute toxicity is available. Therefore, data from a suitable read-across partner was used . For details and justification of read-across please refer to the report attached in section 13 of IUCLID.

In a publication from Ikeda et al. (1986) an LD₅₀ of Sophorolipid (C16-C18), was calculated to be 10500 mg/kg.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

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

Preliminary study:

not applicable

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

ca. 12 500 mg/kg bw

Based on:

test mat.

95% CL:

>= 11 060 - <= 14 130

Mortality:

At the highest dose level of 15000 mg/kg bw, all 10 animals died in between 1 day after administration.
At the dose level of 12500 mg/kg bw, 5 animals died in between 1 day after administration.
At the dose level of 10420 mg/kg bw, 1 animal died in between 1 day after administration.
No other deaths were reported in the 7-day observation period.

Clinical signs:

other: other: reduced locomotion, sedation, hyperventilation, weakness of the extremities, loose stool, diarrhoea, piloerection

Gross pathology:

Individuals which had died showed hyperemia or mild bleeding from the pyloric region of the stomach to the small intestine. No specific abnormalities could be found in the surviving individuals.

Table 1: Deaths of mice and LD₅₀ after oral installation of the test item.

	Number of dead animals during observation period (day)
Dose level [mg/kg bw]	0-1	2-4	5-7	Lethality [%]	LD50 and 95 % CL [mg/kg bw]
7230	0	0	0	0	12500 (11060 – 14130)
8680	0	0	0	0
10420	1	0	0	10
12500	5	0	0	50
15000	10	0	0	100

 

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 of the test item in male mice was determined to be 12500 mg/kg bw.

Executive summary:

The publication by Ikeda et al. (1986) reports the determination of the LD₅₀ value of Sophorolipid in its lactone form. The study meets the principle for determination of acute oral toxicity and has been described in sufficient detail. The study is therefore considered as acceptable for classification purposes.

In this study, 10 fasted male mice per dose group were administered the test item p.o. via gavage. The dose groups were 7230, 8680, 10420, 12500 and 15000 mg/kg bw. The animals were observed for 7 days. Necropsy was conducted after death or in all surviving animals after the observation period. Clinical signs were reduced locomotion, sedation, hyperventilation, weakness of the extremities, loose stool, diarrhoea and piloerection.

The LD₅₀ of Sophorolipid, lactone form, was calculated to be 12500 mg/kg based on test material.

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:

acute toxicity: oral

Type of information:

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

Adequacy of study:

key 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 sinificant 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

Preliminary study:

not applicable

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

ca. 12 000 mg/kg bw

Based on:

test mat.

95% CL:

>= 9 850 - <= 14 650

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

ca. 10 500 mg/kg bw

Based on:

test mat.

95% CL:

>= 9 380 - <= 11 760

Mortality:

see in box "Any other information on results incl. tables".

Clinical signs:

other:

Gross pathology:

Individuals which had died showed hyperemia or mild bleeding from the pyloric region of the stomach to the small intestine. No specific abnormalities could be found in the surviving individuals.

Table 1: Deaths of male mice and LD₅₀ after oral installation of the test item.

Male	Number of dead animals during observation period (day)
Dose level [mg/kg bw]	0-1	2-4	5-7	Lethality [%]	LD50 and 95 % CL [mg/kg bw]
6960	0	0	0	0	12000 (9850-14650)
9120	0	3	0	30
12170	2	1	0	30
16100	7	2	0	90
21290	9	1	0	100

Table 2: Deaths of femalemice and LD₅₀ after oral installation of the test item.

Female	Number of dead animals during observation period (day)
Dose level [mg/kg bw]	0-1	2-4	5-7	Lethality [%]	LD50 and 95 % CL [mg/kg bw]
6960	0	0	0	0	10500 (9380-11760)
8000	2	0	0	20
9210	3	1	0	40
10590	0	2	0	20
12170	4	3	0	70
14000	6	44	0	100

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 of the test item in mice was determined to be 10500 mg/kg bw (female mice).

Executive summary:

The publication by Ikeda et al. (1986) reports the determination of the LD₅₀ value of Sophorolipid (C16-C18). In this study, 10 fasted male and female mice per dose group were administered the test item (37.% w/v) p.o. via gavage at following doses:

Male mice: 6960, 9210, 12170, 16100, 21290 mg/kg bw
Female mice: 6960, 8000, 9210, 10590, 12170, 14000 mg/kg bw

The animals were observed for 7 days. Necropsy was conducted after death or in all surviving animals after the observation period. Clinical signs were decreased locomotor activity, sedation, hyperventilation, weakness of limbs, loose stool, diarrhea, and rising hair. Individuals which had died showed hyperemia or mild bleeding from the pyloric region of the stomach to the small intestine. No specific abnormalities could be found in the surviving individuals.

The LD₅₀ of Sophorolipid (C16-C18) was calculated to be 10500 mg/kg (female mice).

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 there should be no significant differences in the absorption into the body and in the toxicity profile between source and target substance.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

10 500 mg/kg bw

Quality of whole database:

similar to guideline study

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

5 800 mg/kg bw

Quality of whole database:

low; route of administration is subcutanous injection

Additional information

The publication by Ikeda et al. (1986) reports the determination of the LD₅₀ value of Sophorolipid in its lactone form and for Sophorolipid (C16-C18).

In the study conducted with Sophorolipid, lactone form, 10 fasted male mice per dose group were administered the test item p.o. via gavage. The dose groups were 7230, 8680, 10420, 12500 and 15000 mg/kg bw. The animals were observed for 7 days. Necropsy was conducted after death or in all surviving animals after the observation period. Clinical signs were reduced locomotion, sedation, hyperventilation, weakness of the extremities, loose stool, diarrhoea and piloerection.

The LD₅₀ of Sophorolipid, lactone form, was calculated to be 12500 mg/kg based on test material.

 

For Sophorolipid (C16-C18) following doses were used: 

Male mice: 6960, 9210, 12170, 16100, 21290 mg/kg bw
Female mice: 6960, 8000, 9210, 10590, 12170, 14000 mg/kg bw

Clinical signs were decreased locomotor activity, sedation, hyperventilation, weakness of limbs, loose stool, diarrhea, and rising hair. Individuals which had died showed hyperemia or mild bleeding from the pyloric region of the stomach to the small intestine. No specific abnormalities could be found in the surviving individuals.

The LD₅₀ of Sophorolipid (C16-C18) was calculated to be 10500 mg/kg bw (female mice).

Justification for classification or non-classification

The available data are reliable and suitable for classification purposes under Regulation 1272/2008. The substance is not considered to be classified for acute oral toxicity under Regulation (EC) No. 1272/2008.