[No public or meaningful name is available]

Endpoint summary

Description of key information

Weight-of-Evidence for acute oral toxicity was obtained from read-across substances. Epoxidized Soybean Oil (ESBO), Epoxidized 2 -Ethylhexyl ester of tall oil fatty acid (ETP) and 2-Ethylhexyl 9,10-epoxystearate (EMS). The value of 22500 mg/kg bw was obtained as conservative value for oral toxicity. The value of 20000 mg/kg bw was obtained as conservative value for dermal toxicity. Both values exceed the limit dose.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

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

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to valid methods and considered reliable, adequate and relevant.

Principles of method if other than guideline:

No data

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

not specified

Sex:

not specified

Route of administration:

oral: unspecified

Control animals:

not specified

Sex:

not specified

Dose descriptor:

LD50

Effect level:

22.5 mL/kg bw

Based on:

test mat.

95% CL:

> 14 - < 36

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 of Epoxidized Soybean Oil in rats was reported to be 22.5 mL/kg bw.

Executive summary:

The oral LD50 of Epoxidized Soybean Oil (ESBO) in rats was reported to be 22.5 mL/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

22 500 mg/kg bw

Quality of whole database:

Reliable

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

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

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to valid methods and considered reliable, adequate and relevant.

Principles of method if other than guideline:

No data

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

rabbit

Control animals:

not specified

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 20 mL/kg bw

Based on:

test mat.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The dermal LD50 of Epoxidized soybean oil in rabbits indicates a low order of toxicity.
The dermal LD50 is >20 mL/kg.

Executive summary:

The dermal LD50 of Epoxidized soybean oil (ESBO) in rabbits is >20 mL/kg.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

20 000 mg/kg bw

Quality of whole database:

Reliable

Additional information

Weight-of-Evidence for acute oral toxicity was obtained from read-across substances. A read-across justification based on molecular, physicochemical and toxicological properties was written as a separate document provided under Section 13 (Assessment reports). The following data were used:

- The oral LD50 of Epoxidized Soybean Oil (ESBO) in rats was 22.5 mL/kg bw.

- The oral LD50 of Epoxidized 2 -Ethylhexyl ester of tall oil fatty acid (ETP) in rats was 22.6 mL/kg bw.

- The oral LD50 of 2-Ethylhexyl 9,10-epoxystearate (EMS) in rats was 30.8 mL/kg bw.

All read-across studies indicate that there is no acute toxicity after oral administration in rats. The lowest LD50 value of 22.5 mL/kg bw is used for further evaluation. Taking into account a relative density of 1.01 g/mL (ECHA Registered Database), this corresponds with 22.73 mg/kg bw. This exceeds the limit dose for acute oral toxicity (2000 mg/kg bw).

 

Weight-of-Evidence for acute dermal toxicity was also obtained from read-across substances. A read-across justification based on molecular, physicochemical and toxicological properties was written as a separate document provided under Section 13 (Assessment reports). The following data were used:

- The oral LD50 of Epoxidized Soybean Oil (ESBO) in rats was >20 mL/kg bw.

- The oral LD50 of Epoxidized 2 -Ethylhexyl ester of tall oil fatty acid (ETP) in rats was >20 mL/kg bw.

- The oral LD50 of 2-Ethylhexyl 9,10-epoxystearate (EMS) in rats was >20 mL/kg bw.

All read-across studies indicate that there is no acute toxicity after dermal administration in rats. The LD50 value >20 mL/kg bw is used for further evaluation. Taking into account a relative density of 1.01 g/mL (ECHA Registered Database), this corresponds with >20.2 g/kg bw. This exceeds the limit dose for acute dermal toxicity (2000 mg/kg bw).

The oral route was considered most appropriate for the hazard characterization of PLSG-5. Inhalation of the substance is unlikely as the vapour pressure is very low. Skin contact may be likely, however skin absorption is considered to be very low (see Toxicokinetics).

Justification for selection of acute toxicity – oral endpoint
Weight-of-Evidence from read-across substances; this endpoint has the lowest LD50 value.

Justification for selection of acute toxicity – dermal endpoint
Weight-of-Evidence from other read-across substances., with similar LD50 values.

Justification for classification or non-classification

Based on the results and according to the EC criteria for classification and labelling according to CLP regulation (EC No. 1272/2008 of 16 December 2008), 'fatty acids, C16 -18 and C18-unsaturated isopentyl esters, epoxidized' does not have to be classified and has no obligatory labelling requirement for acute oral and dermal toxicity.