Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Read-across to ESBO (EC No. 232-391-0) - Skin irritation/corrosion: Slightly irritating (US EPA 163.81-5 (1978))
Read-across to ESBO (EC No. 232-391-0) - Eye irritation/damage: Slightly irritating (equivalent or similar to OECD 405)

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation/corrosion

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

The read-across in vivo skin irritation/corrosion study (RL2) was conducted according to US EPA 163.81-5 (1978). In the skin irritation/corrosion study, male and female New Zealand white rabbits (3/sex) were dermally exposed to 0.5 mL of ESBO for 24 hours to 6.25 cm2 of body surface area (abraded and intact skin). Animals then were observed for 7 days. Irritation was scored by the method of grading listed on OECD 404. ESBO was found to cause a moderate irritation when applied to intact and abraded rabbit skin. The calculated primary irritation index was 2.6, based on a combined assessment of abraded and non-abraded skin exposed for 24 hours. However, the abraded skin results are not appropriate for assessment under EU classification guidelines. The mean scores are 24 and 72 hours were used as approximations to the 24 – 72 hr mean. Erythema and oedema mean scores were approximated to be 1.5 and 0.75 respectively. Neither result exceeds the EU classification threshold. It is quite likely that the reactions observed were exacerbated by the prolonged exposure and so the estimated mean values are conservative estimates of irritating potential. In this study, ESBO is slightly irritating. EPO is predicted to be slightly irritatin also.

The full read-across report justification is attached.

Eye irritation

There is no eye irritation/corrosion data available for EPO. A read across approach was conducted with an eye irritation study from ESBO (EC No. 232-391-0).

The read-across oral acute toxicity study (RL2) was according to a test guideline that was equivalent or similar to OECD 405. In a primary eye irritation study, 0.1 mL of ESBO (undiluted) was instilled into the conjunctival sac of the left eye of 3 male and 6 female New Zealand white rabbits. In three of the nine rabbits approximately 30 seconds after treatment, the treated eye was flushed with 10 mL of physiological saline. Animals were then observed for 14 days. Irritation was scored by the method of Kay and Callendra from which a PII was derived. For classification purposes the results were re-calculated using a standard Draize score deriving a mean for the reactions over 24-72 hours.In unrinsed eyes, no irritation of cornea and iris was observed at any reading. Irritation was seen only in the conjunctiva with a maximum mean a score of 4.7 after 24 hours. After 10 days all irritation had disappeared. In rinsed eyes, no irritation of cornea and iris was observed at any reading. Irritation was seen only in the conjunctiva with a maximum mean score of 3.3 after 24 hours. After 7 days onwards only one of the three animals had a slight conjunctival redness. Overall, ESBO was found to cause slight irritation (conjunctiva) when applied to the rabbit eye mucosa. EPO is predicted to have a similar result.

The full read-across report justification is attached.


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

Justification for selection of eye irritation endpoint:
Only one read-across study was available.

Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: slightly irritating

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 irritation/corrosion or eye irritation/damage when the criteria outlined in Annex I of 1272/2008/EC are applied, based on the results of the read-across studies from ESBO.

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