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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

There is no skin sensitisation data available for EPO. A read across approach was conducted with a skin sensitisation study from ESBO (EC No. 232-391-0).

The key read-across study (RL2) was conducted according to a guideline that was equivalent or similar to OECD 406. In the study, male and female adult guinea pigs ((Pirbright White); 20 animals in test group, 10 animals in control group) were induced by applications of the test substance: 0.1 % solution of ESBO in 50% propylenglycol/ 50% saline (intradermal; Weeks 1, 2 & 3). During week 6, a challenge of 0.1 % solution of ESBO in 50% propylenglycol/ 50% saline was administered into the skin of the left flank. Twenty-four hours after each injection during the first week of the induction period and 24 hours after the challenge injection the reactions were recorded. During week 8, a sub-irritant dose (30 % ESBO in vaseline) was applied epicutaneously under occlusive dressings which were left in place for 24 hours. The skin irritation was recorded according to Draize. After intradermal challenge, 2/20 animals in both the test and control groups were positive. After occlusive epicutaneous application, 0/20 animals in both the test and control groups were negative. ESBO was considered non-sensitising based on the results of this study. EPO is also predicted to be non sensitising.

The full read-across report justification is attached.

Migrated from Short description of key information:
Read-across to ESBO (EC No. 232-391-0) - Skin sensitisation: Not sensitising (equivalent or similar to OECD 406)

Justification for selection of skin sensitisation endpoint:
Only one read-across study was available.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

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 skin sensitisation when the criteria outlined in Annex I of 1272/2008/EC are applied, based on the results of the read-across study from ESBO.