(ECO)TOXICOLOGY CONSULTING SERVICE

We provide regulatory documentation support required to register products according to the Biocidal Products Regulation (EC) No. 528/2012 (BPR).

• Scientific data search, review, and analysis of available data
• Check for data gaps in line with BPR requirements
• Human health and environmental risk assessments
• Development and creation of product authorization dossiers
• US EPA Conventional Reduced Risk Pesticide Program- Preparation of Reduced Risk Rationale dossier

We provide regulatory documentation support for cosmetics including tox profile and Cosmetic Product Safety Reports (CPSRs) creation under Regulation (EC) 1223/2009.

• Toxicity data mining for all relevant endpoints and exposure routes
• Analysis of data for each endpoint to determine reliability and relevancy
• Drafting ingredient-specific toxicity profiles for cosmetic formulations and generation of PIFs
• Integration of new generation risk assessment methodologies in case of data gaps or poor quality data
• Calculation of margin of safety and risk of cosmetic ingredient and exposure risk assessment

We support companies manufacturing over the counter (OTC) medicine for the appropriate amount of safety and efficacy, consider many different aspects related to product safety.

• Review and analysis of hazard assessment of actives
• Derivation of permissible daily exposure (PDE) levels for active ingredients
• Calculation of sage exposure level for various kinds of contaminants
• Derivation of occupational exposure limits (OEL) for workers
• Toxicological Risk assessment of E&L (Extractables & Leachables) in medical devices
• Preparation of Biological Evaluation Report- Literature based evidence considering toxicological and clinical data

We support to evaluate the safety of constituents present in e-cigarette/vaporizer found in the device (Extractables and leachables (E&L)), constituents found in smoke, and the safety of heat degradants.

• Toxicological Risk assessment of E&L found in the device, smoke constituents and heat degradants
• Evidence of claim and safety analysis of intentionally added substances
• Through literature search to provide information on potential heat degradation/ pyrolysis by-products and their associated toxicity profile.

We support the chemical industry in preparing human health and environmental safety assessments of chemicals by following a systematic approach to data review and integrate ‘weight of evidence’ into assessments. We also provide tailored solutions in the space of safety/hazard assessment, which includes safety assessment for endpoints of concern.

• Systemic toxicity assessment (repeated and DART endpoints), Genotoxicity assessment, and assessment for carcinogenicity
• Assessment for skin sensitization/NESIL and AEL derivation
• Assessment for local endpoints
• Reference dose calculation, BMDL10 calculation, VSD calculation,
• Review information on MSDS.

We support the food industry in evaluating the safety and associated risk across product cycle of materials used in the food industry.

• Toxicological Risk assessment- Food substances, Food contact substances, intentional or non-intentional added substances, packaging material (E&L analysis)
• Calculation of Acceptable Daily intake and associated Margin of exposure
• Safety assessment for botanical ingredients/dietary supplements (Vitamins/ Minerals/ probiotics)- Evidence/claim of efficacy, Regulatory considerations and Safety/ Toxicology data
• Microbiological Hazard Evaluation in foods
• Assistance in preparing GRAS dossier or Novel food application