N-ethylmethacrylamine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October 1986 to February 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 is 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 81-2 (Acute Dermal Toxicity)

Principles of method if other than guideline:

Three group dermal toxicity study similar to the OECD 402 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:

rabbit

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 23 September or 2 December 1986 or 5 January 1987 and dosed on 9 October or 29 December or 2 February 1987 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: 9 February 1987

Administration / exposure

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

No information provided for duration of exposure, preparation of dose sites or any dressing used to occlude the treatment

MAXIMUM DOSE VOLUME APPLIED:6.4 mL C-1033 was administered undiluted as 0.26 ; 2.6 and 6.4 ml to achieve dose levels of 200, 2000 or 5000 mg/kg assuming a Specific Gravity value of 0.78 g/ml

Duration of exposure:

No information

Doses:

200, 2000 and 5000 mg/kg bw

No. of animals per sex per dose:

Four

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:

approximate LD50

Effect level:

> 200 - < 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No rabbits died folowing dermal application of 200 mg/kg bw; 3/4 died at a dose of 2000 mg/kg bw and all four died at 5000 mg/kg bw

Mortality:

None of the four rabbits dosed at 200 mg/kg bw died following dermal application of C-1033. Three mortalities occurred in the 2000 mg/kg bw group and all four rabbits died after dosing at 5000 mg/kg bw.

Clinical signs:

other: No signs observed in the high dose group rabbits that died within 24 hours of dose application. No details are reported for effects in rabbits dosed at 2000 or 200 mg/kg bw other than stating severe dermal response were observed.

Gross pathology:

No data

Other findings:

No information

Any other information on results incl. tables

No information

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category III

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The aucte dermal LD50 was found to be greater than 200 mg/kg bw and less than 2000 mg/kg bw.

Executive summary:

N-ethylmethlyallylamine was administered topically to groups of four rabbits at dose levels of 200, 2000 or 5000 mg/kg bw. All rabbits died in the high dose group and three of four died at 2000 mg/kg bw. Severe, unspecified, dermal responses were recorded in the two lower dose groups. No mortality occurred following application of 200 mg/kg bw. The aucte dermal LD50 was found to be greater than 200 mg/kg bw and less than 2000 mg/kg bw.