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Description of key information

LD50(oral) > 2000 mg/kg bw (Bioassay, 2013)
LD50(dermal) > 2000 mg/kg bw (Bioassay, 2013)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Acute oral toxicity:

In an acute oral toxicity study performed according to the Acute Toxic Class method (OECD 423 guideline and GLP), doses of 2000 mg/kg bw of the test item LUGALVAN BPC dry (preparations in deionized water) were administered to two test groups of three fasted Wistar rats each (2000 mg/kg bw in 6 females) by gavage in a sequential manner.

The following test substance-related clinical observations were recorded:

2000 mg/kg (first test group):

- No mortality occured

- Impaired general state in all animals

- Dyspnoea in all animals

- Piloerection in all animals

- Cowering position in all animals

 2000 mg/kg (second test group):

- No mortality occured

- Impaired general state in two out of three animals

- Piloerection in two out of three animals

There were no macroscopic pathological findings in the surviving animals sacrificed at the end of the observation period.

The mean body weight of the surviving animals increasedwithin the normal rangethroughout the study period.

The acute oral LD50was calculated to be LD50, oral, rat > 2000 mg/kg bw

Acute dermal toxicity:

In an acute dermal toxicity study (Limit Test), young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 2000 mg/kg bw of LUGALVAN BPC dry (as solution in deionized water) to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi-occlusive dressing for 24 hours. The study was conducted according to OECD guideline 402 and GLP (Bioassay, 2013). The application area comprised at least 10% of the total body surface area. The animals were observed for 14 days.

 

No signs of systemic toxicity or skin effects were observed in the animals.

The mean body weight of the animals increased throughout the study period within the normal range.

No mortality occurred. Accordingly, the acute dermal median lethal dose (LD50) was determined to be LD50, dermal, rat > 2000 mg/kg bw


 

Justification for classification or non-classification

Based on the available acute oral and dermal toxicity studies, the substance was neither classified according to Directive 67/548/EEC nor according to CLP.

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