Registration Dossier
Registration Dossier
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EC number: 204-648-7 | CAS number: 123-75-1
Endpoint summary
Administrative data
Description of key information
Two studies on skin irritation/corrosion were performed before OECD guidelines and GLP were in place. Both studies were found to be reliable and show that pyrrolidine has severe effects on the skin. Based on these data, further eye irritation or respiratory irritation studies were waived.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A dermal irritation study with 6 rabbits was performed comparable to current OECD guidelines. It is of note that the substance was applied occlusively for 24 hours. Directly after removal of the substance, haemorrhages, ischemia and moderate oedema were observed. At 48 hours after removal, severe incrustration was seen. No examinations at later time points were included in this study.
Furthermore, skin irritation was tested according to an internal method (BASF IX/409, 1959). White Vienna rabbits were used. 2 animals were treated for 1, 5, 15 minutes using occlusive conditions. An application site of 2.5 x 2.5 cm was covered with the liquid test substance on a patch. After the application time of 1, 5, and 15 minutes, respectively, the skin was first washed with undiluted Lutrol 9, then with an aqueous Lutrol solution (50 %). Already the one-minute exposure duration led to full-thickness necrosis on the skin observed after 24 hours.
Justification for selection of skin irritation / corrosion endpoint:
Study meets generally accepted scientific standards, acceptable for assessment (reliability 2).
Justification for selection of eye irritation endpoint:
Based on skin irritation tests, the substance is classified as corrosive to the skin. Based on regulation (EC) 1907/2006, eye irritation tests do not need to be conducted.
Effects on skin irritation/corrosion: corrosive
Justification for classification or non-classification
Based on the severe effects seen after application to the skin, pyrrolidine is considered to be corrosive. Since full thickness necrosis was already seen after expsoure for 1 minute, the substance is assigned skin corrosive category 1A.
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