GD6-15 Developmental Inhalation

P0 female group:

Maternal body weight change (GD5-15) - extract quantitatively (values reported in the text) and assume p-value of 0.05 for 50,000 ppm group.

Maternal food consumption - use dummy variables

Clinical observation - use dummy variables (no change in clinical condition attributed to exposure)

Table 1 - (number of pregnancies is the sample size) - extract number of abortions, mortality (maternal deaths), fetal weight, gravid uterus weight, corpora lutea/pregnancy, live implantations/pregnancy, early deaths/pregnancy (Resorptions, Early), late deaths/pregnancy (Resorptions/Late), sex ratio.

F1 combined group:

Skeletal Ossification Variations, Total (EHV 5923) - use dummy variables to show no significant changes from control (mention incidence of specific findings are reported in Table 2)

Visceral Abnormalities, Total (EHV 5948 and change name) - use dummy variables to show no significant changes from control (mention incidence of specific findings are reported in Table 3)

1-Generation Reproductive Inhalation

P0 male [exposure duration 10wk premating (6h/d, 5d/wk)] and P0 female subgroup A [exposure duration 2wk premating-GD20 (6h/d, 5d/wk)]

Clinical observation - use dummy variables

Body weight change - use dummy variables (observation time 1-2wk for males and show decrease for 25,000 ppm group, obs time 0-2wk for females and show no changes)

Rats Mating (EHV 16) - (extract under males and females) use dummy variables and show no significant differences

Additional P0 female subgroup A endpoints:

Number of Pregnancies (EHV 14) - use dummy variables and show no significant differences

Length of Gestation - use dummy variables and show no differences

Table 4 - Day 1 sex ratio [which the table refers to as Males (males + females)] (add to results notes that day of birth = Day 1)

Table 5 - Mean Litter Size, Liveborn (No born alive)

F1 combined group:

Table 4 - Day 27 sex ratio

Table 5 - No. alive at 4 days, Lactation Index (obs time PND4-28), Mortality (obs time PND1-28)

Table 6 - extract start and complete for unfolding of pinna, hair growth, eye opening, weaning (use Developmental system for all these, and effect/effect subtype Clinical Observation>Developmental Milestone)

Body weight change, pup - use dummy variables to show no differences

P0 female subgroup B [exposure duration 2wk premating-GD0 (6h/d, 5d/wk)]

Maternal body weight change, clinical observation - use dummy variables and show no differences

Table 7 - extract all - sample size is n=8 for litter data and n=12 for last 2 endpoints (no of pregnant/non-pregnant females)

No differences in gross appearance of dams or fetuses (use Necropsy Appeared Normal)

P0 Female Alpk:AP Rats