Developmental toxicity is a form of inherent hazard. A primary objective of the CleanGredients^® database is to provide guidance for choosing chemicals that are inherently less hazardous than conventional options. Products formulated with safer chemicals have lower risk associated with accidents or exposure across the product lifecycle.

As a prerequisite for being listed in CleanGredients, all solvents must have their developmental toxicity data evaluated by a third party. Solvents listed in CleanGredients must have developmental toxicity test results of at least:

• Oral LOEL/LOAEL > 250 mg/kg-bw/day
• Dermal LOEL/LOAEL >200mg/kg-bw/day
• Inhalation
• (Gas) LOEL/LOAEL >250ppm/6hr/day
• (Vapor) LOEL/LOAEL >1.0mg/L/6hr/day
• (Dust/Mist/Fumes) LOEL/LOAEL >0.2mg/L/6hr/day
Though test data is preferred for this endpoint, analog data is acceptable.

Recommended test methods for developmental toxicity include:

• OECD Test No. 414 - Pre-natal Developmental Toxicity Study
• OECD Test No. 421 – Reproduction/Developmental Toxicity Screening Test
Other similar or significant evidence will also be considered. Please see the OECD SIDS Test Guidelines for more information. “Annex I: OECD Test Guidelines for Studies Included in the SIDS.” Accessible at: http://www.oecd.org/document/23/0,2340,en_2649_34379_1948503_1_1_1_1,00.html You will need to answer the following questions regarding your product:
• Is this a developmental toxicant as defined by GHS? (Yes/No)
• Please submit data for the following three endpoints:
• Oral LD50, mg/kg of body weight
• Dermal LD50, mg/kg of body weight
• Inhalation LC50, ppm/volume/time for gases, mg/L/time for vapors, mg/L/time for dusts and mists
Answers may be in the form of ranges (i.e. >2000). Please specify the species, test method, and testing conditions in the text box provided.