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US NIH - Reproductive & Developmental Monographs

Expert Panel Reports & Monographs on Reproductive and Developmental Toxicity

The National Toxicology Program (NTP) Center for the Evaluation of Risks to Human Reproduction (...

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The National Toxicology Program (NTP) Center for the Evaluation of Risks to Human Reproduction (CERHR) was established in 1998 to serve as an environmental health resource to the public and regulatory and health agencies. The NTP and the National Institute of Environmental Health Sciences established the NTP Office of Health Assessment and Translation (OHAT) to serve as an environmental health resource to the public and to regulatory and health agencies (EHP editorial, May 2011).

This office conducts evaluations to assess the evidence that environmental chemicals, physical substances, or mixtures (collectively referred to as "substances") cause adverse health effects and provides opinions on whether these substances may be of concern given what is known about current human exposure levels.

Assessments of potential adverse effects of environmental substances on reproduction or development carried out by the Center for the Evaluation of Risks to Human Reproduction from 1998-2010, are now carried out by OHAT. OHAT also organizes workshops or state-of-the-science evaluations to address issues of importance in environmental health sciences.

OHAT assessments are published as NTP Monographs. The Monographs assess the evidence that environmental chemicals, physical substances, or mixtures (collectively referred to as “substances”) cause adverse effects on reproduction and development and provide opinion on whether these substances are hazardous for humans.

In the NTP Brief section of the Monograph, the expert panel presents their conclusions in table form on the following:
For Hazard seperately for both human & animal: The weight of evidence that the chemical causes adverse developmental or reproductive toxicant effects in humans (in laboratory animals). This is rated on a 7 point scale from clear evidence of adverse effects to clear evidence of no adverse effects.
For Risk (exposure based): NTP conclusions regarding the possibilities that human development or reproduction might be effected by exposure to the chemical. This is rated on a 6 point scale from insufficient data to negligible concern to serious concern.
The Pharos CML characterizes chemicals based upon the hazard ratings only and weights human and animal hazards equally All chemicals that are somewhere in the evaluation process - that have not had a final Monograph produced are given a Pharos yellow "possible" ranking.

Hazards for Hazard List
Endpoint Hazard Rating and Description GREENSCREEN® HPD C2C
Developmental Toxicity incl. developmental neurotoxicity
Developmental Toxicity incl. developmental neurotoxicity: High hazard High confidence
Clear Evidence of Adverse Effects - Developmental Toxicity Priority List Reproductive Toxicity (Repro + Dev) (Red, Yellow, or Green)
Reproductive Toxicity
Reproductive Toxicity: High hazard High confidence
Clear Evidence of Adverse Effects - Reproductive Toxicity Priority List Reproductive Toxicity (Repro + Dev) (Red)
Developmental Toxicity incl. developmental neurotoxicity
Developmental Toxicity incl. developmental neurotoxicity: Low hazard High confidence
Clear Evidence of no Adverse Effects - Developmental Toxicity Reproductive Toxicity (Repro + Dev) (Green)
Reproductive Toxicity
Reproductive Toxicity: Low hazard High confidence
Clear Evidence of no Adverse Effects - Reproductive Toxicity Reproductive Toxicity (Repro + Dev) (Green)
Reproductive Toxicity
Reproductive Toxicity: High to moderate hazard Low confidence
Limited Evidence of Adverse Effects - Reproductive Toxicity Priority List Reproductive Toxicity (Repro + Dev) (Red)
Developmental Toxicity incl. developmental neurotoxicity
Developmental Toxicity incl. developmental neurotoxicity: High to moderate hazard Low confidence
Limited Evidence of Adverse Effects- Developmental Toxicity Priority List Reproductive Toxicity (Repro + Dev) (Red)
Developmental Toxicity incl. developmental neurotoxicity
Developmental Toxicity incl. developmental neurotoxicity: High to moderate hazard Low confidence
Some Evidence of Adverse Effects - Developmental Toxicity Priority List Reproductive Toxicity (Repro + Dev) (Red)
Reproductive Toxicity
Reproductive Toxicity: High to moderate hazard Low confidence
Some Evidence of Adverse Effects - Reproductive Toxicity Priority List Reproductive Toxicity (Repro + Dev) (Red)
Developmental Toxicity incl. developmental neurotoxicity
Developmental Toxicity incl. developmental neurotoxicity: Moderate to low hazard Low confidence
Limited Evidence of no Adverse Effects - Developmental Toxicity Reproductive Toxicity (Repro + Dev) (Red, Yellow, or Green)
Reproductive Toxicity
Reproductive Toxicity: Moderate to low hazard Low confidence
Limited Evidence of no Adverse Effects - Reproductive Toxicity Reproductive Toxicity (Repro + Dev) (Red, Yellow, or Green)
Developmental Toxicity incl. developmental neurotoxicity
Developmental Toxicity incl. developmental neurotoxicity: Moderate to low hazard Low confidence
Some Evidence of no Adverse Effects - Developmental Toxicity Reproductive Toxicity (Repro + Dev) (Red, Yellow, or Green)
Reproductive Toxicity
Reproductive Toxicity: Moderate to low hazard Low confidence
Some Evidence of no Adverse Effects - Reproductive Toxicity Reproductive Toxicity (Repro + Dev) (Red, Yellow, or Green)
Developmental Toxicity incl. developmental neurotoxicity
Developmental Toxicity incl. developmental neurotoxicity: High to low hazard Low confidence
Insufficient Evidence for a Conclusion - Developmental Toxicity Reproductive Toxicity (Repro + Dev) (Red, Yellow, or Green)
Reproductive Toxicity
Reproductive Toxicity: High to low hazard Low confidence
Insufficient Evidence for a Conclusion - Reproductive Toxicity Reproductive Toxicity (Repro + Dev) (Red, Yellow, or Green)
Developmental Toxicity incl. developmental neurotoxicity
Developmental Toxicity incl. developmental neurotoxicity: Potential concern hazard
Developmental Toxicity - Nominated for study Reproductive Toxicity (Repro + Dev)
Reproductive Toxicity
Reproductive Toxicity: Potential concern hazard
Reproductive Toxicity - Nominated for study Reproductive Toxicity (Repro + Dev)

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