Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

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.