N-ethylmethacrylamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

September 1986 to January 1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Data presented as a summary report to TSCA under the Section 8 (e) Compliance Audit Programme for Reportable Adverse Effects. A full study report is not available for evaluation of the overall study reliability but the data summary presented to TSCA are adequate to determine the acute endpoint.

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPP 81-1 (Acute Oral Toxicity)

Principles of method if other than guideline:

Three group oral toxicity study similar to the OECD 401 test guidelines.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

N-ethyl methyl allylamine

IUPAC Name:

N-ethyl methyl allylamine

Constituent 2

Reference substance name:

N-ethylmethacrylamine

EC Number:

242-217-5

EC Name:

N-ethylmethacrylamine

Cas Number:

18328-90-0

Molecular formula:

C6H13N

IUPAC Name:

N-ethyl-2-methylprop-2-en-1-amine

Test material form:

other: clear yellowish liquid

Details on test material:

- Name of test material (as cited in study report): C-1033 (N ethyl methyl allylamine)
- Physical state: clear yellowish liquid
- Analytical purity: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data

- Storage condition of test material: 60-85°F (circa 16-30°C)
- Other: Specific Gravity stated as 0.78 g/mL

Test animals

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: No data
- Age at study initiation: No information
- Weight at study initiation: No data
- Fasting period before study: No data
- Housing: No information
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: animals received on 16 or 23 September or 9 December 1986 and dosed on 9 or 16 October or 31 December respectively

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Room monitored over temperature range of circa 16-30°C
- Humidity (%): No information
- Air changes (per hr): No information
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: From: 9 October 1986 To: 7 January 1987

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED:6.4 mL C-1033 was administered undiluted as 0.06 ; 0.64 and 6.4 ml to achieve dose levels of 50, 500 or 5000 mg/kg assuming a Specific Gravity value of 0.78 g/ml

DOSAGE PREPARATION (if unusual): not applicable

Doses:

50, 500 and 5000 mg/kg

No. of animals per sex per dose:

six

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: No data
- Necropsy of survivors performed: no data
- Other examinations performed: clinical signs, record of mortalities

Statistics:

No data

Results and discussion

Preliminary study:

Not applicable

Effect levels

Sex:

not specified

Dose descriptor:

LD50

Effect level:

50 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 3 of 6 rats dosed at 50 mg/kg bw died and all of the rats dosed at 500 or 5000 mg/kg bw died

Mortality:

3 of 6 rats died at 50 mg/kg bw
6 of 6 rats died at 500 mg/kg bw
6 of 6 rats died at 5000 mg/kg bw

Clinical signs:

other: At 5000 mg/kg bw: No signs noted At 500 mg/kg bw: The following signs were observed but no details of time of onset, duration, incidence within group or severity are indicated - Fine tremors, red nasal discharge, dyspnoea, abdominal griping, hypoactivity

Gross pathology:

No data

Other findings:

No data

Any other information on results incl. tables

No further information

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category II

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 was determined to be 50 mg/kg bw.

Executive summary:

In an acute oral toxicity study, three groups of six rats were dosed with undiluted C-1033 (N-ethylmethylallylamine), by oral gavage, at dose levels of 50, 500 or 5000 mg/kg bw. Three of six rats dosed at 50 mg/kg bw died and ante-mortem clinical signs included red nasal and oral discharges, oral discharge, hypopnoea, dyspnoea, unthrifty hair coat, abdominal griping, partially closed eyes, hypoactivity, decreased or no food consumption. All of the rats dosed at 500 or 5000 mg/kg died and while no clinical signs were noted in the high dose group, a similar clinical profile was observed in the 50 and 500 mg/kg groups. The LD50 was therefore determined to be 50 mg/kg bw.