Quaternary ammonium compounds, bis(hydrogenated tallow alkyl)dimethyl, chlorides, reaction products with polyethylenepolyamines and tall-oil fatty acids, humates hydrochlorides

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2013-07-16 to 2013-08-16

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Details on test material:

- Substance type: UVCB
- Physical state: powder

Test animals

Species:

rat

Strain:

other: CD [Crl:CD(SD)]

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Portage, Michigan
- Age at study initiation: Approximately 7 weeks
- Weight at study initiation: 177-199 g
- Fasting period before study: Animals fasted overnight prior to dosing (up to 16 hr)
- Housing: Housed 2-3 per cage to allow for co-mingling in solid bottom cages
- Diet (e.g., ad libitum): Block Lab Diet Certified Rodent Diet #5002, PMI Nutrition International, Inc. available ad libitum
- Water (e.g., ad libitum): Tap water available ad libitum
- Acclimation period: 7 to 10 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): ~ 20 to 26°C (68 to 79°F)
- Humidity (%): 30 to 70%
- Photoperiod (hrs dark / hrs light): 12 hr dark/12 hr light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 400 mg/mL
- Lot/batch no. (if required): 2CA0440

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 females total

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Prior to randomization (Day -1) and on Days 1, 7, and 14
- Necropsy of survivors performed: Yes
- Other examinations performed: Gross macroscopic examination conducted after necropsy

Statistics:

Not applicable

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No adverse effects observed at the highest dose tested.

Mortality:

No mortalities were observed.

Clinical signs:

other: No treatment-related clinical signs of toxicity were observed.

Gross pathology:

No treatment-related macroscopic changes were observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

An oral LD50 of > 2000 mg/kg was established in female rats based on a lack of mortality.

Executive summary:

In an acute oral toxicity study, five fasted, female CD [Crl:CD(SD)] rats were given a single oral dose of organolignite in corn oil at a dose of 2000 mg/kg and observed for 14 days. There were no treatment related clinical signs, necropsy findings or changes in bodyweight. The oral LD50 was determined to be > 2000 mg/kg in females.