Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
Two minor deviations that did not have any negative impacts on the results were described in the full study report and given in more detail below.
GLP compliance:
yes
Remarks:
GLP compliance statement is included in attached full study report
Test type:
up-and-down procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
Sample ID: CP-100
0.18% complex polymeric polyhydroxy acids (based on total organic carbon content of 0.1%)
Density: 0.9968 g/mL

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
Experimental Animals
Source: Texas Animal Specialties, Humble, TX
Date Born / Date Received: 2 Jun 2009 / 23 Jul 2009
Quarantine Period: 5 days
Quantity & Sex: 3 females (nulliparous and non-pregnant)
Animal/Group Identification: Ear punch / Cage cards
Day-1 Weight / Day 0 (fasted) Weight: 171-195 g / 150-172 g

Animal Husbandry
Cage Type: suspended, wire bottom, stainless steel
House: 1 per cage
Environmental Controls: set to maintain 22 °C (+/- 3 °C), 30-70% relative humidity, 12 hour light/dark cycle, 10-12 air changes/hour. Actual temp/humidity: 21-22 °C, 54-92% relative humidity
Food: PMI Feeds Inc. Formulab #5008, available ad libitum except for approximately 16 hours before dosing
Water: Municipal water supply analyzed by TCEQ Water Utilities Division; available ad libitum from automatic water system
Animal husbandry and housing at STILLMEADOW, Inc. comply with standards outlined in the “Guide for the Care and Use of Laboratory Animals” (NRC Publ.). No contaminants were expected to have been present in the feed or water that would have interfered with or affected the results of the study.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Each dose was administered using an appropriately sized syringe and stainless steel ball-tipped intubation needle.
Doses:
The test substance was administered as received and was not diluted. An individual dose was calculated for each animal based on its fasted body weight and administered by gavage at a volume of 5.02 mL/kg. The animals were returned to their cages immediately after dosing.
No. of animals per sex per dose:
3 females per dose
Control animals:
no
Details on study design:
In-Life Observations
Observations for mortality and clinical/behavioral signs of toxicity were made at least three times on the day of dosing (Day 0) and at least once daily thereafter for 14 days. Individual body weights were recorded just prior to dosing and on days 7 and 14.

Postmortem Observations
On Day 14 after dosing, each animal was euthanized by CO2. All study animals were subjected to gross necropsy and all abnormalities were recorded.

Results and discussion

Preliminary study:
Normal at each observation
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
There was no mortality during the study. The estimated acute oral LD50, as indicated by the data, was determined to be greater than 5000 mg/kg.
Clinical signs:
All animals appeared normal for the duration of the study.
Body weight:
Body weight gain was unaffected by the administration of the test substance.
Gross pathology:
Necropsy Findings
The gross necropsy conducted at termination of the study revealed no observable abnormalities.

Any other information on results incl. tables

Body Weights, Time of Death, and Gross Necropsy


Dose: 5000 mg/kg (5.02 mg/kg)













































Animal #Dose (mL)Date of DosingDay 0 (g)Day 7 (g)Day 14 (g)Time of DeathNecropsy Findings
310.8634 Aug 09172178213Day 14No observable abnormalities
320.7526 Aug 09150179192Day 14No observable abnormalities
330.8436 Aug 09168185198Day 14No observable abnormalities

 


Protocol Deviations:


1)      One animal weight under protocol range but did not affect study outcome


2)      Humidity was outside protocol range but did not affect study outcome

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The test substance was evaluated for its acute oral toxicity potential when administered to albino rates. The acute oral LD50 is estimated to be greater than 5000 mg/kg in females.