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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2013-07-09 to 2013-08-02

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:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

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:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Covance Research Products, Inc., Greenfield, Indiana
- Age at study initiation: Approximately 5-6 ½ months
- Weight at study initiation: 2.92 to 3.19 kg males; 2.90 to 3.08 kg females
- Housing: Individually housed in suspended, stainless steel, slatted floor cages
- Diet (e.g., ad libitum): Lab Diet® Certified Rabbit Diet #5322 limited upon arrival and increased in 25 g increments during the acclimation period until feeding was 125 g per day
- Water (e.g., ad libitum): Tap water available ad libitum
- Acclimation period: Approximately 10 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): ~ 16 to 22°C (61 to 72°F)
- Humidity (%): 30 to 70%
- Photoperiod (hrs dark / hrs light): 12 hr dark/12 hr light

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal area
- % coverage: 10%
- Type of wrap if used: gauze dressing secured with non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes
- Time after start of exposure: 24-25 hr after exposure

TEST MATERIAL
- For solids, paste formed: yes/no

VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:

Duration of exposure:

24-25 hr

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 males and 5 females

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for morbidity, mortality, injury, and food and water availability were conducted twice daily for all animals. Animals were observed on Day 1 at approximately 30 minutes, and 1, 2, and 4 hours after application for clinical signs of toxicity. Animals were then observed once a day thereafter until Day 14. Body weights were measured prior to randomization and on Days 1, 7, and 14.
- Necropsy of survivors was performed on Day 15

Statistics:

Not applicable

Results and discussion

Effect levels

Sex:

male/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 mortality was observed.

Clinical signs:

other: No adverse clinical signs of toxicity were observed.

Gross pathology:

There were no treatment-related macroscopic observations in either males or females.

Other findings:

No other treatment-related findings reported.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The dermal LD50 in rats was > 2000 mg/kg.

Executive summary:

In an acute dermal toxicity study, groups of New Zealand White Hra:(NZW)SPF rabbits (5/sex) were dermally exposed to organolignite moistened in water for 24 hours to 10% of the dorsal body surface area at doses of 2000 mg/kg bw. Animals then were observed for 14 days.

 

There were no treatment related clinical signs, necropsy findings or changes in body weight. The dermal LD50 was determined to be > 2000 mg/kg in male and female rabbits.