Registration Dossier
Registration Dossier
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EC number: 700-751-0 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Acute toxicity was tested according to OECD TG 423 and GLP. 2 x3 female Wistar rats were given 2000 mg/kg bw by gavage. No mortality occurred and no clinical signs or effects on weight gain were observed. Thus, the LD50 cut-off of Ca-/Mg-salt of fumarated tall oil rosin is > 5000 mg/kg bw.
Acute dermal toxicity was tested according to OECD TG 402 and GLP by applying 2000 mg/kg bw on the back of male and female rats for 24 hours and a 14 day post exposure observation period. The resulding LD50 is >2000 mg/kg bw.
Key value for chemical safety assessment
Additional information
ORAL APPLICATION
According to OECD TG 423 3 female Wistar rats were given 2000 mg/kg bw by gavage. 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, or 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 fumarated tall oil rosin is > 5000 mg/kg bw (Bayer Pharma AG 2011).
DERMAL APPLICATION
Acute dermal toxicity was tested according to OECD TG 402 and GLP. 2000 mg/ kg bw test substance was applied to the back of male and female Wistar rats for 24 hours covered by a semi occlusive dressing. After removal of the dressing and the test substance the animals were observed for further 14 days. No mortality occurred and no clinical signs or effects on body weight development were observed. Gross pathological examination revealed no findings. Thus, the LD50 (dermal, rat) is > 2000 mg/kg bw under the condition of this test (Bayer Pharma AG 2011).
Justification for classification or non-classification
Based on the available data no classlification or labelling is required.
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