Dimethylammonium 2,4-dichlorophenoxyacetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Oct 1997 - Dec. 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP - Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

, only one sex is tested

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Dimethylammonium 2,4-dichlorophenoxyacetate

EC Number:

217-915-8

EC Name:

Dimethylammonium 2,4-dichlorophenoxyacetate

Cas Number:

2008-39-1

Molecular formula:

C8H6Cl2O3.C2H7N

IUPAC Name:

dimethylammonium 2,4-dichlorophenoxyacetate

Details on test material:

- Name of test material (as cited in study report): Aminopielik 720 SL
- Physical state: light brown solution with characteristic smell
- Analytical purity: 726 g/L of 2,4-D

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Institute of Occupational Medicine, Lodz, Poland
- Age at study initiation: 3 months (mean)
- Weight at study initiation: 190 g (mean)
- Fasting period before study: 20 h
- Housing: plastic metal cage (35 x 30 x 20 cm3), 5 animals of the same sex per cage
- Diet: "Murigran" ad libitum
- Water: ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 40 - 80
- Photoperiod (hrs dark / hrs light): 12 /12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 5 ml/kg bw

Doses:

507, 659, 857 and 1114 mg/kg bw

No. of animals per sex per dose:

5 (only female animals)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical examination was carried out every hour on the day of application, afterwards at least twice daily. The mortality and all signs of intoxication
were assessed.
Individual weight was determined shortly before the test substance was administered and on days 7 and 14.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

764 mg/kg bw

Based on:

test mat.

Mortality:

After exposure 0, 1, 3 and 5 rats died in the dose groups 507, 659, 857 and 1114 mg/kg bw, respectively. The mortality occurred during the first day (all 3 affected dose groups) and on day 2 and 4 (857 mg/kg bw dose group) after application.

Clinical signs:

other: Shortly after application of the test substance (0.5 - 2 hours) rats in all dose groups were less mobile, had unstable equilibrium and weak reactions to external impulses. Animals dosed with 857 mg/kg bw showed this intoxication signs till the fourth day

Gross pathology:

In 4 rats (one animal of the dose groups 659 and 857 mg/kg bw respectively and two animals treated with 1114 mg/kg bw) lung hyperemia was observed.
In animals that survived the observation period no gross pathologic changes were found.

Any other information on results incl. tables

Table 1: Acute oral toxicity of Aminopielik 720 SL

Dose mg/kg bw	Mortality of rats after x hours of intoxication (rat identification number)					Sum
	3 h	24 h	48 h	72 h	96 h
507	-	-	-	-	-	0
659	-	8	-	-	-	1
857	-	15	11	-	14	3
1114	16 17	18 19 20	-	-	-	5

Table 2: Body weight gain

Dose mg/kg bw	No of rat	Day of experiment			Difference day 14- day 1
		1	7	14
507	1 2 3 4 5	191 189 206 185 186	214 210 223 209 207	222 217 241 225 221	31 28 35 40 35
659	6 7 8 9 10	179 182 185 180 179	205 205 - 224 207	220 216 - 244 213	41 34 - 64 34
857	11 12 13 14 15	206 195 192 200 221	- 208 216 - -	- 232 234 - -	- 37 42 - -
1114	16 17 18 19 20	186 187 188 189 182	- - - - -	- - - - -	- - - - -

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Remarks:

Migrated information