Ephedrine

Endpoint summary

Description of key information

The test substance is corrosive to the skin and eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation / corrosion

The potential to cause acute dermal irritation or corrosion was assessed in two similar to OECD 404 guideline study by a single topical application of 0.5 g to the intact skin of Vienna White rabbits using a patch of 2.5 cm x 2.5 cm, covered with occlusive dressing (BASF 1981). In the first study, skin was exposed for 3 minutes or 1 hour. After removal of the patch, the application area was washed off with lutrol and lutrol/water (1:1). The cutaneous reactions were assessed immediately after removal of the patch and approximately 24 and 48 hours, and 8 days after removal. In animals exposed for 3 min no effects were observed. In 3 out of 4 animals exposed for 1 hour redness and edema was observed 24 and 48 hours after exposure. Haemorrhagic crustae were also visible in 2 out of 4 animals at the 24 hours after exposure. Necrosis was observed in all animals 8 days after exposure. It was concluded that the test substance was corrosive. In the second study, skin was exposed for 24 hours. After removal of the patch, the application area was assessed for cutaneous reactions approximately 24 and 72 hours, and 8 days after removal. Necrosis and edema was observed in all exposed animals at 24 and 72 hours, and 8 days after exposure. It was concluded that the test substance was corrosive.

Eye irritation

The potential to cause damage to the conjunctiva, iris of cornea was assessed in an similar to OECD 405 guideline study in 6 white Vienna rabbits subjected to a single ocular application of 0.1 mL of the test substance on day 0 (BASF 1981). Effects on conjunctiva, iris and cornea were observed. Findings were not reversible within 8 days. Scars were also observed 8 days after exposure. It was concluded that the test substance causes severe eye damage.

Justification for selection of skin irritation / corrosion endpoint:
Two skin irritation / corrosion studies are available. In one study animals were exposed for a short period of time (3 minutes and 1 hour). In the other animals, were exposed for a long period of time (24 hours). Because effects were already observed in animals exposed for 1 hour, this study was selected for an endpoint conclusion.

Justification for selection of eye irritation endpoint:
One eye irritation study is available. This study is adequate for covering this endpoint.

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

Necrosis of the skin was observed in all animals exposed to the test substance solution for 24 hours, but also in animals exposed for 1 hour. Based on this, ephedrine has to be classified as Skin Corr. 1B: H314: Causes severe skin burns and eye damage in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008 and as C: R34: Causes burns in accordance with EU Directive 67/548 (DSD).

Scars and other signs of corrosion were observed in the eyes of all exposed animals 8 days after exposure. Based on this ephedrine has to be classified as Eye damage 1: H318: Causes serious eye damage in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008. As ephedrine is already classified as C:R34 in accordance with EU Directive 67/548 (DSD), the substance does not need to be be classified as Xi:R41: Risk of serious damage to eyes.