N-ethylmethacrylamine

Endpoint summary

Description of key information

Published summaries of acute oral and dermal toxicity studies are available.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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.

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

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

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

Preliminary study:

Not applicable

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

No further information

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

50 mg/kg bw

Quality of whole database:

Reliable with some restrictions - the information is only available as a summary of results submitted to TSCA and consequently much of the methodology is omitted

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

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.

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

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

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

Preliminary study:

Not applicable

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

No information

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

200 mg/kg bw

Quality of whole database:

Reliable with some restrictions - the information is only available as a summary of results submitted to TSCA and consequently much of the methodology is omitted

Additional information

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.

In an acute dermal toxicity study, 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.

Justification for selection of acute toxicity – oral endpoint

Only one study available for this endpoint

Justification for selection of acute toxicity – dermal endpoint

Only one study available for this endpoint

Justification for classification or non-classification

Based on the results of the acute oral toxicity study which indicates an acute oral LD50 of 50 mg/kg bw, N-ethylmethylallylamine is classified for acute oral toxicity in Category 2, H300: Fatal if swallowed; in accordance with Regulation (EC) No. 1272/2008 (CLP Regulation).

Based on the results of the acute dermal toxicity study which indicates an acute oral LD50 of >200 mg/kg bw and <2000 mg.kg bw, N-ethylmethylallylamine is classified for acute dermal toxicity in Category 3, H311: Toxic in contact with skin; in accordance with Regulation (EC) No. 1272/2008 (CLP Regulation).