Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
06/22/1987 - 07/06/1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP conducted study following EPA Guideline 81-1 (1982)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 81-1 (Acute Oral Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
clear, colorless liquid; stored at room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Young adult male and female albino rats of the Sprague-Dawley strain were procured, separated by sex, maintained in group cages in temperature and humidity controlled quarters, provided continuous access to Purina Rodent Chow and water and held for an acclimation period of at least 7 days. Animal husbandry and housing at the lab at which the study was conducted comply with the standards outlined in the "Guide for the Care and Use of Laboratory Animals."
Acclimated animals were chosen at random for the study. Test animals were housed by sex in groups of five and identified by animal number and corresponding ear tag. Food and water were available ad libitum throughout the study, except for an overnight period just before test material administration when food, but not water, was withheld.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
An individual dose was calculated for each animal based upon its fasted body weight and administered undiluted by gavage.
Doses:
The dose volume of the test material was 5.26 mL/kg of body weight based upon an average bulk density of 0.95 g/mL.
No. of animals per sex per dose:
5 males, 5 females
Control animals:
no
Details on study design:
5 male and 5 female Sprague-Dawley rats were exposed by oral gavage to the undiluted test material at a level of 5.26mL/kg of body weight based upon an average bulk density of 0.95 g/mL. The animals were observed for clinical signs and mortality at 1, 2.5, 4 hours after test material administration. The animals were observed daily thereafter for 14 days for clinical signs and twice daily for mortality. All animals were weighed just before test material administration, at 7 days and at study termination. At study termination all animals were euthanized, subjected to a gross necropsy examination, and all abnormalities were recorded.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was see in the test animals.
Clinical signs:
All test animals were observed as appearing normal at 1.0 and 2.5 hours after dosing. At the 4.0 hour observation time point, 2/5 in both the male and female groups were observed as having diarrhea. Observations made on Days 1 and 2 indicated and all five animals of each sex had yellow-stained genital regions. Observations made on days 3 - 14 found the animals appearing normal.
Body weight:
Body weight was recorded prior to the test, on day 7 and at test termination. See table below:

Average Body Weights (g)
Initial Day 7 Terminal
Male 247 319 358
Female 211 238 247
Gross pathology:
The five male rats showed no visible lesions. Three of the 5 female rats also showed no visible lesions. The necropsy comments for one female rat indicated Kidney (right) - enlarged pelvis filled with tan granules. The necropsy comments for a second female rat indicated Spleen - opaque capsule over entire surface.

Applicant's summary and conclusion

Conclusions:
A 14 day acute oral gavage rat toxicity study was conducted using five male rats and five female rats. The estimated oral LD50 for both males and females is >5.0 g/kg of body weight.
Executive summary:

Isodecyl benzoate was administered by oral gavage to 5 male and 5 female Sprague Dawley rats at the at the limit dose of 5.0 g/kg bodyweight to assess the acute oral lethality. An individulal dose was calculated for each animal based on its fasted body weight (202 -280 g range) and administered undiluted. The animals were observed for clinical signs at 1, 2.5 and 4 hours after test material administration and daily thereafter for 14 days for clinical signs and twice daily for mortality. Animals were weighed just before test material administration, at 7 days, and at 14 days, study termination. There was no mortality. All animals were euthanized and subjected to a gross necropsy examination and all abnormalities were recorded. The five male rats showed no visible lesions. Three of the 5 female rats also showed no lesions. The necropsy comments for one female indicated right kidney enlarged pelvis filled with tan granules and for the second female, the indication was an opaque capsule over the entire spleen surface. The LD50 was determined to be greater than 5000 mg/kg. This finding does not warrant the classification of isodecyl benzoate under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substancs and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.