![[logo] US EPA](../gif/logo_epaseal.gif){kind=logo}
Data Evaluation Record - An Acute Oral Toxicity Study of Granola 97 in Rats MRID No.: 44438701
DATA REVIEW FOR ACUTE ORAL TOXICITY TESTING (§152-10; 870.1100)
Related Information
Information related to this page:Study Title: An Acute Oral Toxicity Study of Granola 97 in Rats
EPA Reviewer: Sheryl K. Reilly, Ph.D.
Biopesticides and Pollution Prevention Division (7511C)
Date 1/25/98MRID No.: 44438701
File Jacket Symbol: 4822-UOO
DP Barcode: D243976
Study No.: 3068.64
Study Completion Date: October 16, 1997Sponsor: S.C. Johnson & Son, Inc., Racine, WI 53403-2236
Testing Facility: Springborn Laboratories, Inc., Spencerville, OH 45887
Author: Bonnette, K.L.
Quality Assurance (40 CFR '160.12): Included
Test Material: Granola 97 (99% p-Menthane-3,8-diol); Lot 703001; clear viscous liquid
Species: Sprague-Dawley Crl:CD®BR VAF/Plus® Rats
Age: Males: Approximately 8 weeks; Females: approximately 9-13 weeks
Weight (prefasted): Males: 247-262 g; Females: 202-222 g
Source: Charles River Laboratories, Inc., Portage, MI
Conclusions:
- LD50 (mg/kg): > 5000 mg/kg
Males: > 5000 mg/kg
Females: = 5308.4 mg/kg (95% C.L. 2325.7-12116.5 mg/kg)
Combined: > 5000 mg/kg- Tox. Category: IV
- Classification: Acceptable
Procedural Deviations from Subdivision M Guideline '152-10: None
Number of Deaths/Number Tested Dose Males Females Combined
Observations:
In an acute oral toxicity study, 5 groups of 5 female rats were dosed with 500, 875, 1250, 2000 and 5000 mg/kg body weight, and 1 group of 5 male rats were dosed at 5000 mg/kg. The primary clinical signs of toxicity were decreased activity in 1 female (500 mg/kg group) and all 5 females in the 1250 mg/kg group, and reduced/no feces were observed in 2 rats in this dose group. Wobbly gait was observed in 5 female rats at 1250 mg/kg. Other clinical effects noted in the 3 other dose groups included breathing abnormalities, prostration, apparent hypothermia, hunched posture, urine stain, ocular discharge, decreased food consumption, and/or dark material around the facial area. All rats had normal body weight gains except 1 female in the 1250 mg/kg group. Two females in the 2000 mg/kg group and 2 females in the 5000 mg/kg group died by day 3 of the studies; none of the male rats died during the study. The timing of these observations was not specified, so it cannot be determined if these were immediate or delayed effects.
Gross Necropsy:
The most notable gross internal findings were observed in the animals that died and included abnormal contents in the digestive tract, reddened mucosa of the stomach, dilated pelvis of the kidney, pale liver, blackish-purple spleen, distended ureters, and dark red thymus. Gross necropsy was normal on the surviving rats.