N-(butoxymethyl)acrylamide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26 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 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

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:

rabbit

Strain:

New Zealand White

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 2.1 - 2.9 kg
- Housing: 1 per cage in suspended wire cages. Bedding was placed beneath the cages and changed at least three times/week.
- Diet: ad libitum
- Water: ad libitum
- 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: Animals were received 21 June, 05 July, 26 July and 23 August 2006
- To: Not reported; date of last data collection was 04 September 2006

Administration / exposure

Type of coverage:

other: occlusive at the lower dose levels, semi-occlusive at the highest dose

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
Prior to application of the test article, the back and sides of each animal were clipped free of hair and remained intact.
- Area of exposure: Approximately 10 %
- Type of wrap if used: Test material was applied under a 4 ply porous gauze dressing measuring 10 x 15 cm at the lower dose levels. The top dose was applied to the prepared site on top of the gauze dressing. The torso was wrapped with plastic sheeting in an occlusive manner for animals dosed at 500, 1000 and 1500 mg/kg. Animals dosed at 2000 mg/kg were wrapped in a semi-occlusive manner. Plastic sheeting was secured with non-irritating tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test sites were wiped, not washed
- Time after start of exposure: After 24 hours

TEST MATERIAL
Doses were based on the sample weight as calculated from the specific gravity.
- Amount applied:
1.3 to 1.5 cc at 500 mg/kg bw
2.5 to 2.8 cc at 1000 mg/kg bw
3.3 to 3.6 cc at 1500 mg/kg bw.
4.6 to 6.0 cc at 2000 mg/kg bw

VEHICLE
The test material was used as received

Duration of exposure:

24 hours

Doses:

500, 1000, 1500 and 2000 mg/kg

No. of animals per sex per dose:

Initially, five healthy males were dosed at 500 mg/kg of body weight.
At the sponsor's request and to further characterise the test material, three additional groups of five males were dosed at 1000, 1500 and 2000 mg/kg.

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Animals dosed at 500 mg/kg were observed at 1, 4 and 24 hours post-dose and animals dosed at 1000, 1500 and 2000 mg/kg were observed at 1, 4 and 24 hours post-dose for mortality, toxicity and pharmacological effects. Animals were observed once daily thereafter for six days for mortality only. Body weights were recorded pre-test and at termination.
- Necropsy of survivors performed: No.
- Other examinations performed: The test sites were scored for dermal irritation at 24 hours post-dose and on day 7 using the Numerical Draize scoring code. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction. Additional signs were described.

Erythema and eschar formation:
0: No erythema
1: Very slight erythema (barely perceptible)
2: Well-defined erythema
3: Moderate to severe erythema
4: Severe erythema (beet redness) to slight eschar formation (injuries in depth)

Oedema formation:
0: No oedema
1: Very slight oedema (barely perceptible)
2: Slight oedema (edges of area well-defined by definite raising)
3: Moderate oedema (edges raised approximately 1 millimetre)
4: Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure)

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

None, all animals survived

Clinical signs:

other: All animals appeared normal at post-dose assessments up to 24 hours.

Gross pathology:

Not performed.

Other findings:

- At 500 mg/kg: Dermal effects ranged from very slight to slight on Day 1 and from absent to well-defined on Day 7.
- At 1000 mg/kg: Dermal effects ranged from absent to well-defined on Day 1 and from absent to very slight on Day 7.
- At 1500 mg/kg: Dermal effects ranged from absent to very slight on Days 1 and 7.
- At 2000 mg/kg: Dermal effects ranged from very slight to slight on Day 1 and from absent to very slight on Day 7.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified in accordance with EU criteria

Conclusions:

The LD50 of the test material is greater than 2000 mg/kg body weight.