Registration Dossier
Registration Dossier
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EC number: 205-642-7 | CAS number: 144-83-2
Endpoint summary
Administrative data
Description of key information
LD50(oral, mice, 24h): >2000 mg/kg body weight
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
There are two publications performed to assess the acute toxicity of sulphapyridine by oral and subcutaneous route, but no available data for dermal and inhalation route was obtained.
In the key study performed byH. B. Van Dyke et al,1939,1000, 15000 and 2000 mg/kg bw were applied to the test mice. After 24 hours, the mortality of 19%, 25% and 31% were observed respectively. LD50 value by oral isconclude to begreater than 2000 mg/kgbw.
In another study investigated by H.A. Walker and H.B. van Dyke, 1940, 500, 750 and 1000 mg/kg bw were administrated to the mice subcutaneously. After 72 hours, the mortalities of 4%, 17% and 97% were observed respectively in the three dose level. Thus the LD50-72h(subcutaneously) was 807 ± 79 mg/kg bw.
According to the CLP regulation, the classification of acute oral toxicity was justified based on 24-hour testing exposure to a substance. Therefore, this supporting publication will be given less weight as LD50-72h subcutaneously was derived following oral administration of 72 hours.
Justification for selection of acute toxicity – oral endpoint
This study was well-conducted and fulfill scientific principles.
Justification for classification or non-classification
Based on the available data, the mortality of 31% were observed up to the dose of 2000 mg/kg bw after 24 hours exposure to sulphapyridine. LD50 (oral, mice) was determined to be greater than 2000 mg/kg bw. Therefore, the substance cannot be classified for acute oral toxicity according to CLP (Regulation EC No. 1272/2008).
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