§ 69402.4. Evidence for Developmental Toxicity Hazard Trait.

(a) Each of the following constitutes strong evidence of developmental toxicity for a given chemical substance:

(1) Identification as known to the state to cause reproductive toxicity with developmental toxicity denoted as an endpoint in Title 27, California Code of Regulations, section 27001.

(2) Meeting the National Toxicology Program criteria as having clear or sufficient evidence of adverse effects for developmental toxicity.

(3) Meeting the criteria for being classified as Category 1, known or presumed human reproductive toxicant based on developmental toxicity data, under the United Nation's Globally Harmonized System for Classification and Labeling.

(4) Identification in the National Institute for Occupational Safety and Health's Pocket Guide to Chemical Hazards as having teratogenic or other developmental effect.

(5) Identification as a known or potential developmental toxicant or having the capacity to cause developmental toxicity in a report published by the National Academy of Sciences' National Research Council or Institute of Medicine.

(6) Identification as having sufficient evidence of carcinogenicity by the International Agency for Research on Cancer, with a clear statement that the chemical substance induces transplacental carcinogenesis noted in an International Agency for Research on Cancer Monograph on the Evaluation of Carcinogenic Risks to Humans.

(7) Recognition as a developmental toxicant by an authoritative organization.

(b) Each of the following constitutes suggestive evidence of developmental toxicity for a given chemical substance:

(1) Meeting National Toxicology Program criteria as having some or limited evidence of adverse effects for developmental toxicity.

(2) Identification as having limited evidence of carcinogenicity by the International Agency for Research on Cancer, with a clear statement that the chemical substance may induce transplacental carcinogenesis noted in an International Agency for Research on Cancer Monograph on the Evaluation of Carcinogenic Risks to Humans.

(3) Recognition as a suspected developmental toxicant by an authoritative organization.

(4) Strong evidence for the Genotoxicity Hazard Trait pursuant to Article 3 subsection 69403.5 of this Chapter or the Endocrine Toxicity Hazard Trait pursuant to Article 3 subsection 69403.3 of this Chapter with mechanisms of genotoxicity or endocrine toxicity likely to be involved in developmental toxicity.

(5) Strong indications from supportive studies, as described by the National Toxicology Program, indicating possible developmental toxicity.

(6) Mechanistic evidence that is suggestive of developmental toxicity potential, from cell-based, tissue-based or whole organism-based assays showing perturbations of known physiological, biochemical or other pathways involved in developmental toxicity.

(7) Strong indications of developmental toxicity from structure activity relationships, including but not limited to those from Quantitative Structure Activity Relationship models.

HISTORY

1. New section filed 12-20-2011; operative 1-29-2012 (Register 2011, No. 51).

Note

Note: Authority cited: Sections 25256.1 and 59012, Health and Safety Code. Reference: Sections 25256.1 and 59012, Health and Safety Code.