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Description of key information

In female Wistar rats the oral LD50 is > 2000 mg/kg bw (related to dry mass). 

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

The acute oral toxicity in female Wisar rats was studied using the Limit test according to OECD Guideline 423 (Acute Toxic Class Method). Two groups, each of three rats, were treated with 7.12 mL/kg bw undiluted Biofert Plusz by oral gavage corresponding to 2000 mg/kg body weight dry mass of the test item. All animals were examined for clinical signs within the first 30 minutes and approximately 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically at termination. No clinical signs were observed during the course of the study. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were recorded at necropsy. The LD50 is > 2000 mg/kg bw (dry mass).

The acute dermal toxicity in male and female Wisar rats was studied using the Limit test according to OECD Guideline 402. Five male and 5 female Wistar rats received dermal application to the clipped skin of 7.12 mL/kg bw undiluted Biofert Plusz corresponding to 2000 mg/kg body weight dry mass of the test item. The semi-occlusive dressing was removed after 24 h of exposure and the skin was washed. All animals were examined for clinical signs within the first 30 minutes and approximately 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically at termination. No clinical signs were observed during the course of the study. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were recorded at necropsy. The LD50 is > 2000 mg/kg bw (dry mass).

Justification for classification or non-classification