Palm oil, epoxidized

Endpoint summary

Description of key information

Read-across to ESBO (EC No. 232-391-0): LD50 >5000mg/kg bw (equivalent or similar to OECD 401)
Read-across to ESBO (EC No. 232-391-0): LD50 >20 mL/kg bw (equivalent or similar to OECD 402)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

The key study was a read-across study from ESBO and is the only study available. It was assigned a Klimisch score of 2.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

20

Quality of whole database:

Two read-across studies from ESBO were available. Both were assigned a Klimisch score of 2.

Additional information

Acute oral toxicity

There is no acute oral toxicity data available for EPO. A read across approach was conducted with an oral toxicity study from ESBO (EC No. 232-391-0).

The read-across oral acute toxicity study (RL2) was conducted according to a guideline that was equivalent or similar to OECD 401. In the study, ESBO was administered to male and female Tif: RAIf (SPF) rats (5/group) at 5000 mg/kg bw in a limit test. There were no mortalities. Mild clinical signs were noted (slight dyspnoea, slightly ruffled fur, slight diarrhoea and a slightly curved body position) on Day 1 with some cases of ruffled fur and curved body position persisting on days 2 to 4. No gross organ changes were noted. The LD50 (male/female) > 5000 mg/kg bw. An LD50 of >5000 mg/kg bw is also predicted for EPO.

The full read-across report justification is attached.

Acute dermal toxicity

There is no acute dermal toxicity data available for EPO. A read across approach was conducted with dermal toxicity studies from ESBO (EC No. 232-391-0).

Two read-across acute dermal toxicity studies are available. The key read-across study (RL2) was conducted according to a guideline equivalent or similar to OECD 402. In this study, groups of young male New Zealand rabbits (4/sex) were dermally exposed (occlusive) to ESBO (undiluted) for 24 hours at a dose of 20 mL/kg bw. Animals then were observed for 13 days. There were no mortalities and no evidence of derm l toxicity in the 4 rabbits treated. The dermal LD50 (males) for ESBO was >20 mL/kg bw. The dermal LD50 (males) for EPO is also predicted to be >20 mL/kg bw.

The supporting read-across study (RL2) was conducted according to a guideline equivalent or similar to OECD 402. In this study, groups of rabbits were dermally exposed to ESBO at a dose of 20 mL/kg bw. The dermal LD50 for ESBO was >20 mL/kg bw. The dermal LD50 for EPO is also predicted to be >20 mL/kg bw.

The full read-across report justification is attached.

Justification for selection of acute toxicity – oral endpoint
Only one read-across study was available.

Justification for selection of acute toxicity – dermal endpoint
Two read-across studies from ESBO were available. The key study was chosen as it contained the most information.

Justification for classification or non-classification

Based on the available information in the dossier, the substance EPO (CAS No. 1006899‐79‐1) does not need to be classified for acute toxicity or STOT-SE when the criteria outlined in Annex I of 1272/2008/EC are applied, based on the results of the read-across study from ESBO.