[2-(acryloyloxy)ethyl]trimethylammonium chloride

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12/01/1990-25/01/1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well documented report of a guideline study conducted to GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

[2-(acryloyloxy)ethyl]trimethylammonium chloride

EC Number:

256-176-6

EC Name:

[2-(acryloyloxy)ethyl]trimethylammonium chloride

Cas Number:

44992-01-0

Molecular formula:

C8H16NO2.Cl

IUPAC Name:

Trimethyl[2-(prop-2-enoyloxy)ethyl]azanium chloride

Details on test material:

- Name of test material: ADQUAT MC 80
- Source: Norsolor
- Lot/batch No.: 169 bis
- Purity: 80 % in water
- Impurities (identity and concentrations): methyl chloride < 0.1%
- Physical state: pale yellowish liquid
- pH: 7-9
-density: 1.12
- Storage condition of test material: 4°C

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Iffa Credo, L'Arbresle, France
- Strain: Sprague-Dawley ICO: OFA-SD
- Age at study initiation: approximately 6 weeks
- Weight at study initiation: 181 ± 8 g (males) and 144 ± 5 g (females)
- Acclimation period: 5 days
- Fasting period before study: 18 hours
- Housing: polycarbonate cage
- Diet : Ad libitum. UAR "Rats et souris Entretien référence A04 C"
- Water: Ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12 hours

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Water + methyl cellulose

Details on oral exposure:

VEHICLE
- Concentration in vehicle: Methyl cellulose MC4000, 0.5 % solution in water
- Amount of vehicle (if gavage): 10 ml/kg
- Justification for choice of vehicle: advised by the material supplier
- Lot/batch no. : Methyl cellulose MC4000 N° 87320, sterilized Water: N°1279
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg

Doses:

In a first experiment, the test substance was administered undiluted at 500 mg/kg. A second experiment was then performed at 500, 900, 1600, 2000 and 2900 mg/kg in males and at 900, 1600 and 2000 mg/kg in females.

No. of animals per sex per dose:

Number of animals per dose group: 5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: once a day
- Clinical signs: at least once a day;
- Mortality: recorded at least twice a day;
- Body weight: measured just before administration then on days 5, 8 and 15.
-Necropsy:
- macroscopic examination of the main organs.
- microscopic examination: no

Statistics:

No

Results and discussion

Preliminary study:

- When administered at 500 mg/kg (0.45 ml/kg), the test substance induced tonic-clonic convulsions, a reddish ocular secretion and exophtalmia were observed just after administration in all animals. These finding were observed just before the death of 3 males and 1 female.

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD0

Effect level:

500 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 1 600 - < 2 000 mg/kg bw

Based on:

act. ingr.

Mortality:

- At 500 mg/kg no deaths occurred
- At 900 mg/kg, 1 female died on day 2.
- At 1600 mg/kg, 2 males died on day 2.
- At 2000 mg/kg, all animals died on day 1.
- At 2900 mg/kg, 2 males were found dead: 1 at 30 minutes, 1 at 4 hours and 2 died on day 2.

Clinical signs:

other: - Hypokinesia , sedation and dyspnea were observed in 500 mg/kg (10 ml/kg) (males only) and 900 mg/kg treated groups, within 30 minutes of administration. - The same effects were observed up to 4 hours after exposure in the 1600 mg/kg group. In this group

Gross pathology:

No abnormalities were observed in dead or sacrificed animals in the 500, 900 and 1600 mg/kg groups. Nevertheless, in the 500 mg/kg (0.45 ml/kg) group and in the 2000 mg/kg group, dead animals exhibited black liver coloration and hardening of the heart.

Any other information on results incl. tables

Sex	Dose mg/kg	Cumulative Mortality				Mortality %
		Day 1	Day 2	Day 5	Day 15
Males	500	0	0	0	0	0
	900	0	0	0	0	0
	1,600	0	2	2	2	40
	2,000	5	5	5	5	100
	2,900	3	5	5	5	100
Females	900	0	1	1	1	20
	1,600	0	0	0	0	0
	2,000	5	5	5	5	100

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute LD50 for Adamquat MC 80 was determined to be between 1600 and 2000 mg/kg bw. The substance is considered to be harmful by the oral route.