Table 7.

Summary of studies evaluating ocular 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
Animal studies (inhalation)
NTP (2000)	Male and female rats (Fischer 344); 2-y (105-wk) exposure	Inhalation (whole body)	0, 52, 157, $314{\mathrm{mg}/\mathrm{m}}^3$	Histopathology of eyes	No effects observed	High. This study was well designed to evaluate this outcome. Evidence was presented clearly and transparently.	Suitable. Multidose study with quantitative data.
NTP (1992b)	Male and female mice (B6C3F1); 2-y (103-wk) exposure	Inhalation (whole body)	0, 52, $157{\mathrm{mg}/\mathrm{m}}^3$	Examination of eyes by slit-lamp biomicroscopy and indirect ophthalmoscopic procedures	No effects observed	High (females). This study was well designed to evaluate this outcome. Evidence was presented clearly and transparently. Low (males). The high mortality rate in control males has the potential to interfere with the interpretation of results.	Suitable. Multidose study with quantitative data.
Animal studies (oral)
Battelle (1980b)	Male and female rats (Fischer 344); 90-d exposure	Oral gavage	0, 25, 50, 100, 200, $400\mathrm{mg}/\text{kg-d}$	Histopathological evaluation of eyes	No effects observed	High. This study was well designed to evaluate this outcome. Evidence was presented clearly and transparently.	Suitable. Multidose studies with quantitative data.
Battelle (1980a)	Male and female mice (B6C3F1); 90-d exposure	Oral gavage	0, 12.5, 25, 50, 100, $200\mathrm{mg}/\text{kg-d}$	Histopathological evaluation of eyes	No effects observed	High. This study was well designed to evaluate this outcome. Evidence was presented clearly and transparently.	Suitable. Multidose studies with quantitative data.
Holmén et al. (1999)	Female rats (Brown Norway); 10-wk exposure	Oral gavage	0, 100, 500, 1,000, $\mathrm{1,500}\mathrm{mg}/\text{kg-d}$ (dosed twice per week)	Evaluation of cataractous changes using lens photography	Cataractous changes correlated with naphthalene dose	Medium. Some concerns were raised over the small sample size of the control and some reporting limitations (method of dosing not reported, chemical purity not reported), but overall appears to be a well-conducted study.	Suitable. Multidose studies with quantitative data.
Shopp et al. (1984)	Male and female mice (CD-1); 14- or 90-d exposure	Oral gavage	14-d exposure: 0, 27, 53, $267\mathrm{mg}/\mathrm{kg}/\mathrm{d}$ 90-d exposure: 0, 5.3, 53, $133\mathrm{mg}/\text{kg-d}$	Examination of eyes (methods not reported)	No effects observed	Medium. This study was well-designed to evaluate these outcomes, but confidence was decreased because only qualitative results are provided.	Not suitable. Quantitative results not reported.
Animal studies (dermal)
Bushy Run (1986)	Male and female rats (Sprague-Dawley CD); 90-d exposure	Dermal	0, 100, 300, $\mathrm{1,000}\mathrm{mg}/\text{kg-d}$	Examination with indirect ophthalmoscope prior to dosing and prior to final sacrifice	No effects observed	High. This study was well designed to evaluate this outcome. Evidence was presented clearly and transparently.	Suitable. Multidose study with quantitative data.