Reaction mass of bis(N-decyl-N,N-dimethyldecan-1-aminium) carbonate and N-decyl-N,N-dimethyldecan-1-aminium hydrogen carbonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study according to international guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: FIFRA (40 CFR)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Test material form:

other: solid gel

Details on test material:

- Name of test material: Didecyldimethylammonium carbonate

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: Young adults
- Weight at study initiation:
Male: 242 – 300 g
Female: 189 – 254 g

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 5 %

Doses:

Dose range finding: 100, 250, 500 mg a.i./kg
Definitive test: 25, 50, 100, 200, 400, 800 mg a.i./kg

No. of animals per sex per dose:

Dose range finding: 2/sex/group
Definitive test: 5/sex/group

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Day 0, 7 and 14
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs

In addition the post-exposure observation period was extended to 21 days for those rats exposed to 200 and 400 mg/kg of Carboquat due to the toxic effects observed on day 14.

Results and discussion

Preliminary study:

For results see table 1a below. Definitive test doses were based on the results obtained in the preliminary test.

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

245 mg/kg bw

Based on:

act. ingr.

95% CL:

135 - 443

Effect levels 2

Sex:

male/female

Dose descriptor:

LD0

Effect level:

25 mg/kg bw

Based on:

act. ingr.

Mortality:

For results see table 1b below.

Clinical signs:

other: A variety of clinical signs were observed for males and females in the 800 mg a.i./kg bw treatment group which died as a result of treatment. These signs were generally indicative of increased secretions, changes in the appearance of the fur and posture,

Gross pathology:

Findings in the animals that died during the observation period were those generally seen in agonal animals with additional observation generally seen in response to the oral administration of an irritating material. All animals at the 400 mg a.i./kg bw dose level and one animal at the 200 mg a.i./kg bw dose level which survived the observation period exhibited tissue adhesions in the peritoneal cavity in the area of the stomach. Furthermore, all animals which survived the observation period at the 100 mg a.i./kg bw dose level exhibited livers and spleens which appeared pitted. In all other animals which survived the observation period there were no gross pathological findings.

Any other information on results incl. tables

Table 1a: Group incidence of mortality - Dose range finding screen:

Dose (mg a.i./kg)	Mortality (No. dead/No. dosed)
	Male	Female
500	2/2	2/2
250	2/2	2/2
100	0/2	0/2

Table 1b: Group incidence of mortality - Definitive test

Dose (mg a.i./kg)	Mortality (No. dead/No. dosed)
	Male	Female
800	5/5	5/5
400	2/5	4/5
200	2/5	3/5
100	1/5	0/5
50	0/5	1/5
25	0/5	0/5

 

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral toxicity study revealed a LD50 of 245 mg a.i./kg bw (135 – 443 mg a.i./kg bw) and a NOEL of 25 mg a.i./kg bw.

Executive summary:

A study was carried out according to OECD Guideline 401 (Acute Oral Toxicity) and US FIFRA (40 CFR). The study was performed on male and female Sprague Dawley rats at dose levels of 800, 400, 200, 100, 50 and 25 mg a.i./kg bw. All levels were dosed with a 5 % w/w aqueous formulation of DDACarbonate. Rats were observed for 14 days post-dosing. A gross necropsy was performed on any animal that died and at the end of the observation period, all animals were sacrificed for gross necropsy. The acute oral toxicity study revealed a LD50 of 245 mg a.i./kg bw (135 – 443 mg a.i./kg bw) and a NOEL of 25 mg a.i./kg bw.