Acute / subchronic / chronic toxicity

Tests:

In vitro: Haut- und Augentoxizität

• In vitro skin irritation / corrosion OECD 439, 431, 435
• In vitro eye irritation / corrosion OECD 437, 438, 492, 492B, 460
• In vitro skin sensitisation OECD 429, 409, 442C, 442D, 442E
• In vitro skin adsorption OECD 428

In vivo: acute toxicity

• Acute / short-term oral toxicity in the rat OECD 423, 420, 425
• Acute / short-term oral toxicity in the mouse OECD 423, 425
• Acute / Short-term inhalational toxicity in the rat OECD 403 , 433, 436
• Acute / short-term dermal toxicity in the rat OECD 402
• Acute / short-term dermal toxicity in rabbits OECD 404
• Acute / short-term eye toxicity rabbit OECD 405
• Sensitisation OECD 429, 409
• Dermal adsorption OECD 427
• “Acute six pack toxicity studies”

In vivo subchronic and chronic toxicity

• Dose-range studies (DRF) over 14 days
• 28 day oral / parenteral repeated dose toxicity study in rodents OECD 407
• 28 day repeated dose dermal toxicity study in rats OECD 410
• 28 day repeated dose inhalation toxicity study in rats OECD 412
• 90 day oral / diatic / parenteral repeated dose toxicity study in rats, with or without satellite or recovery group OECD 408
• 90 day dermal toxicity study in the rat OECD 411
• 90 day inhalation toxicity study in the rat OECD 413
• Carcinogenicity study in the rat OECD 451
• Chronic toxicity study in the rat OECD 452
• Combined chronic carcinogenicity study in the rat OECD 453

Oral toxicity

• In vivo acute oral toxicity – Fixed dose OECD 420
• In vivo acute oral toxicity – Acute toxicity class method OECD 423
• In vivo acute oral toxicity – up-and-down method OECD 425

cytotoxicity

• Cytotoxicity test on extract ISO 10993-5:2009 / 2020
• Cytotoxicity test in direct contact ISO 10993-5
• Agar diffusion test ISO 10993-5 (Annex B)
• Skin sensitisation ISO 10993-10:2021, OECD 406, 429, 442C, 442D, 442E
• Skin irritation / intracutan reactivity ISO 10993-10, OECD 439

Systemic toxicity

• Acute systemic toxicity ISO 10993-11:2017, OECD 402, 420, 423, 425
• Repeated subacute toxicity ISO 10993-11, OECD 407
• Repeated subchronic toxicity ISO 10993-11, OECD 408
• Repeated chronic toxicity SO 10993-11, OECD 452

Material-related pyrogenicity ISO 10993-11, ISO 10993-20 (draft), USP 151
Implantation effects ISO 10993-6:2016
Hemocompatibility in vitro, ex vivo and in vivo testing in vitro, ex vivo and in vivo testing ISO 10993-4:2017
Carcinogenicity study in rats OECD 451 , ISO 10993-3:2022
Combined chronic and carcinogenicity study in rats OECD 453, ISO 10993-3