Soil organic matter, alkaline extract, sodium salt

Acute Toxicity: oral

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

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

Test material information

Constituent 1

Reference substance name:

Soil organic matter, alkaline extract, potassium salt

Cas Number:

1175006-56-0

IUPAC Name:

Soil organic matter, alkaline extract, potassium salt

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 or test system 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 Dosing	Day 0 (g)	Day 7 (g)	Day 14 (g)	Time of Death	Necropsy Findings
31	0.863	4 Aug 09	172	178	213	Day 14	No observable abnormalities
32	0.752	6 Aug 09	150	179	192	Day 14	No observable abnormalities
33	0.843	6 Aug 09	168	185	198	Day 14	No 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.