Registration Dossier
Registration Dossier
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EC number: 700-750-5 | CAS number: -
Endpoint summary
Administrative data
Description of key information
According to OECD TG 423 the LD50 (oral) cut-off of Ca/Mg-salt of Tall Oil Pitch (TOP) is >5000 mg/kg bw. Result from tests with Tall-Oil Pitch showed neither acute oral nor acute dermal effects resulting in LD50 values for both routes > 2000 mg/kg bw.
Key value for chemical safety assessment
Additional information
Oral Application of Ca/Mg-salt of Tall-Oil Pitch:
According to OECD TG 423 three female Wistar rats were given 2000 mg/kg bw by gavage and observed for further 14 days. No mortality occurred and no clinical signs or effects on weight gain were observed . Therefore the test was repeated with further 3 female Wistar rats. Again, the dose of 2000 mg/kg bw was tolerated by female rats without mortalities and effects on weight gain. No gross pathological findings were noted from both groups of female Wistar rats. Thus, the LD50 cut-off of Ca-/Mg-salt of tall oil pitch (TOP) is > 5000 mg/kg bw (Bayer Pharma AG 2011).
Data for read-across substance Tall-Oil Pitch:
Acute oral toxicity:
The key acute oral toxicity study is the only study available for this endpoint. The test was carried out in accordance with OECD Test Guideline 425 and in compliance with GLP, and was therefore assigned Reliability 1. The observed LD50 was greater than 2000 mg/kg bw.
Acute dermal toxicity:
The key acute dermal toxicity study is the only study available for this endpoint. The test was carried out in accordance with OECD Test Guideline 402 (limit test) and in compliance with GLP, and was therefore assigned Reliability 1. The observed LD50 was greater than 2000 mg/kg bw.
Acute inhalation toxicity:
No data are available for acute inhalation toxicity.
Justification for classification or non-classification
Based on the available data no cassification and labelling is required.
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