N-(butoxymethyl)acrylamide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

29 June 2006 to 13 October 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-(butoxymethyl)acrylamide

EC Number:

217-442-7

EC Name:

N-(butoxymethyl)acrylamide

Cas Number:

1852-16-0

Molecular formula:

C8H15NO2

IUPAC Name:

N-(butoxymethyl)prop-2-enamide

Test material form:

liquid

Details on test material:

- Physical state: Clear liquid
- Storage conditions of test material: Room temperature and humidity. Avoid prolonged storage above 100 °F.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: The pre-test body weight range was 209 - 230 g
- Age at study initiation: Approximately 8 weeks
- Fasting period before study: 16 - 20 hours prior to dosing
- Housing: Animals were housed 1 per cage in suspended wire mesh cages. Bedding was placed beneath the cages and changed at least three times/week.
- Diet: Freely available
- Water: Freely available at all times
- Acclimation period: At least three days

ENVIRONMENTAL CONDITIONS
- Temperature: Not reported, the room was temperature controlled
- Photoperiod: 12 hour light / dark cycle

IN-LIFE DATES:
- From: 27 June 2006
- 10 July 2006

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: The test material was used as received. The dose was based on the sample weight as calculated from the specific gravity.

MAXIMUM DOSE VOLUME APPLIED: 0.24 cc

Doses:

1000 mg/kg

No. of animals per sex per dose:

Five males

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Animals were observed 1, 4 and 24 hours post-dose for mortality, toxicity and pharmacological effects. Mortality was recorded once daily thereafter for six days.
- Necropsy of survivors performed: No. All animals were humanely sacrificed using CO2 following the study termination.

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 1 000 mg/kg bw

Based on:

test mat.

Mortality:

2 animals died during the test period; the first within 24 hours of administration, the second on Day 2.

Clinical signs:

other: Pre-death observations included lethargy, wetness and red staining of the nose/mouth area, negative righting reflex, convulsions, spasms, tremors, unkempt appearance, few faeces, ataxia and wetness of the anogenital area. Instances of lethargy, wetness an

Any other information on results incl. tables

Table 1: Dose Volume and Body Weight

Animal No.	Sex	Dose Volume (cc)	Body weight (g)
			Day 0	Day7
1	Male	0.24	230	299
2	Male	0.22	216	N/A
3	Male	0.22	209	267
4	Male	0.23	217	N/A
5	Male	0.23	221	280
Mean			219	282
S.D.			7.7	16.1
Number			5	3

N/A = Not applicable – Animal died before observation period

 

Table 2: Systemic Observations

Time Period	Animal No. / Sex
	1/M	2/M	3/M	4/M	5/M
1 hour	B	B	B, R, T	B, R	B, R
4 hours	B	B, 1	B, R, I	B, R, I	B, R, T, I
24 hours		1, 2, K, B, I, P, O, 3, X, E	1	Z (204 G)	1, R, B, 3, X
Day 2		1, 2, R, K, I, P, O, X, E, Z (193 G)			1, R, X
Day 3					2, R
Day 4
Day 5
Day 6
Day 7

No entry indicates that the animal appeared normal at that observation period.

B = Lethargy

E = Ataxia

I = Convulsion

K = Negative righting reflex

O = Tremors

P = Spasm

R = Anogenital area wet

T = Anogenital area soiled

X = Few faeces

Z = Dead

1= Nose/mouth area stained red

2 = Nose/mouth area wet

3 = Unkempt appearance

Applicant's summary and conclusion

Interpretation of results:

other: Category 4 in accordance with EU criteria

Conclusions:

Based on the results of this test, the LD50 of the test material was > 1000 mg/kg bw.