Table 6.

Summary of studies evaluating developmental effects.

Author and publication year	Study description	Route of exposure	Exposure measurement	Outcome(s) evaluated	Outcomes(s) observed	Overall confidence level for outcome	Applicability for dose–response
Human studies (nonspecific route of exposure)
Agarwal et al. (2020)	General population cross-sectional health survey of 110 pregnant women (18–40 y old excluding smokers, and those who had previous history of serious chronic disease or had pregnancy complications) with attending antenatal care at Gynecology Department, S. N. Medical College, Agra, India, during the period from March 2017 to September 2018	Nonspecific route of exposure	Placental tissue levels of naphthalene	Birth weight	No statistically significant association of birth weight with naphthalene exposure	Medium. All domains were evaluated as at least adequate.	Limited suitability. Cross-sectional study design with limited ability to assess temporality. Also, insufficient availability of data or models to relate urinary metabolites to exposure levels.
Gong et al. (2018)	General population cross-sectional health survey of all registered births in Texas by Texas residents from 1996–2008; case–control design was used to investigate the associations between maternal residential proximity to the emission sources of these chemicals and LBW.	Nonspecific route of exposure	Estimated based on residential proximity to industrial facilities reporting to U.S. EPA’s Toxic Release Inventory	LBW	Statistically significantly higher odds of LBW in maternal residences exposed to naphthalene	Medium. All domains are evaluated as at least adequate.	Not suitable. No quantitative exposure level data. Cross-sectional study design with limited ability to assess temporality.
Nie et al. (2018)	General population cross-sectional health survey of 287 pregnant women in Taiyuan, China	Nonspecific route of exposure	Creatinine-adjusted urinary metabolite levels (2-OH-naphthalene)	Birth weight, birth length, birth head circumference, and two growth proportionality indices.	Statistically significant association with lower birth weight and higher cephalization index	Medium. All domains are evaluated as at least adequate.	Limited suitability. Cross-sectional study design with limited ability to assess temporality. Also, insufficient availability of data or models to relate urinary metabolites to exposure levels.
Wang et al. (2014)	General population cross-sectional health survey of preschool-age children (4-5 y) in Nanjing, China	Nonspecific route of exposure	Indoor and outdoor dust levels of naphthalene	Neurobehavioral scores based on the Child Behavior Checklist and Gesell Development Inventory	Statistically significant association with higher “internalizing problem” score on the Child Behavior Checklist, which is a measure of anxiety, depression, withdrawal, and/or somatic complaints	Medium. All domains except sensitivity were evaluated as adequate.	Limited suitability. Exposure levels are reported only as overall mean, median, and range. Cross-sectional study design with limited ability to assess temporality.
Animal studies (oral)
NTP (1992a)	Female rabbits (New Zealand); exposure from GD 6–19, sacrifice on GD 30	Oral gavage	0, 20, 80, $120\mathrm{mg}/\mathrm{kg}-\mathrm{d}$	Fetal viability (live and dead fetuses, implantations, resorptions), fetal body weight, and gross, visceral, and skeletal alterations	Increased incidence of malformed female fetuses (statistically significant trend); the malformation increased in the fetuses was fused sternebrae.	High. This study was well-designed to evaluate these outcomes. Evidence was presented clearly and transparently.	Suitable. Multidose studies with quantitative data.
NTP (1991)	Female rats (Sprague-Dawley); exposure from GD 6–15, sacrifice on GD 20	Oral gavage	0, 50, 150, $450\mathrm{mg}/\mathrm{kg}-\mathrm{d}$	Fetal viability (live and dead fetuses, implantations, resorptions), fetal body weight, and gross, visceral, and skeletal alterations	Increased incidence of malformed fetuses and adversely affected implants per litter (statistically significant trend), and decreased fetal body weight (statistically significant trend)	High. This study was well-designed to evaluate these outcomes. Evidence was presented clearly and transparently.	Suitable. Multidose studies with quantitative data.
Pharmakon Research (1986)	Female rabbits (New Zealand); exposure from GD 6–18, sacrifice on GD 29	Oral gavage	0, 40, 200, $400\mathrm{mg}/\mathrm{kg}-\mathrm{d}$	Fetal viability (live and dead fetuses, implantations, resorptions), fetal body weight, and gross, visceral, and skeletal alterations	Statistically significant decrease in fetuses with extra 13th right-sided rib	High. This study was well-designed to evaluate these outcomes. Evidence was presented clearly and transparently	Suitable. Multidose studies with quantitative data.
Pharmakon Research (1985)	Female rabbits (New Zealand); exposure from GD 6–18, sacrifice on GD 29	Oral gavage	0, 50, 250, 630, $\mathrm{1,000}\mathrm{mg}/\mathrm{kg}-\mathrm{d}$	Fetal viability (live and dead fetuses, implantations, resorptions), fetal body weight, and gross, visceral, and skeletal alterations	No effects in the 50 or $250\mathrm{mg}/\mathrm{kg}-\mathrm{d}$ groups. (Fetuses in 630 and $\mathrm{1,000}\mathrm{mg}/\mathrm{kg}-\mathrm{d}$ groups were not evaluated due to mortality or abortion in all does in these dose groups.)	High. This study was well-designed to evaluate these outcomes. Evidence was presented clearly and transparently.	Suitable. Multidose studies with quantitative data.
Plasterer et al. (1985)	Female mice (CD-1); exposure from GD 7–14, dams allowed to deliver	Oral gavage	0, $300\mathrm{mg}/\mathrm{kg}-\mathrm{d}$	Pup viability, postnatal body weight	Statistically significant decrease in live pups per litter on PND 1 and 3, with no change in dead pups per litter; suggests that this effect was due to early resorptions	High. This study was well-designed to evaluate these outcomes. Evidence was presented clearly and transparently	Suitable. Multidose studies with quantitative data.

Note: GD, gestational day; LBW, low birth weight; PND, postnatal day: .