N-ethyl-N-(3-methylphenyl)propionamide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11 June 1996 to 25 June 1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-ethyl-N-(3-methylphenyl)propionamide

EC Number:

423-640-6

EC Name:

N-ethyl-N-(3-methylphenyl)propionamide

Cas Number:

179911-08-1

Molecular formula:

C12H17NO

IUPAC Name:

N-ethyl-N-(3-methylphenyl)propanamide

Test material form:

liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Remarks:

Hsd:Sprague-Dawley(CD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan UK Ltd, Bicester, Oxon, England
- Females (if applicable) nulliparous and non-pregnant: [yes/no]
- Age at study initiation: 4 to 7 weeks
- Weight at study initiation: 92 to 105g
- Fasting period before study: Yes (overnight)
- Housing: in groups of up to five rats of the same sex in metal cages with wire mesh floors in Building R14 Room 6
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 5 days under experimental conditions


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): 15 per hour
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours night

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The test item was administrated, as supplied, at a volume of 2.0 ml/kg bodyweight.
The appropriate dose volume of the test substance was administered to each rat by oral gavage using a syringe and plastic catheter
A group of ten rats (five males and five females) was treated at 2.0 g/kg bodyweight.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 (five males and five females)

Control animals:

no

Details on study design:

Mortality

Cages of rats were checked at least twice daily for any mortalities.

Clinical signs

Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1 (a period of five hours). On subsequent days animals were observed once in the morning and again at the end of the experimental day (with the exception of Day 15 - morning only). This latter observation was at approximately 16.30 hours on week days or 11.30 hours on Saturdays and Sundays. The nature and severity of the clinical signs and time were recorded at each observation.

All animals were observed for 14 days after dosing.

Bodyweight

The bodyweight of each rat was recorded on Days 1 (prior to dosing), 8 and 15. Individual weekly bodyweight changes and group mean bodyweights were calculated.


Termination

All animals were killed on Day 15 by cervical dislocation.

Macroscopic pathology

All animals were subjected to a macroscopic examination which consisted of opening the abdominal and thoracic cavities. The macroscopic appearance of all tissues was recorded.

Statistics:

No statistical analysis was used.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 5 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths following a single oral dose of the test item to a group of ten rats (five males and five females) at a dosage of 2.0 g/kg bodyweight.

Clinical signs:

other: Piloerection and increased salivation were observed in all rats within three minutes of dosing. These signs persisted and were accompanied in all rats later on Day I by hunched posture and pallor of the extremities. In addition, waddling gait, lethargy, d

Gross pathology:

No macroscopic abnormalities were observed for animals killed on Day 15.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute lethal oral dose to rats of the test item was found to be greater than 2000 mg/kg bodyweight.

Executive summary:

A study was performed to assess the acute oral toxicity of the test item to the rat. The method followed was that described in EEC Methods for the determination of toxicity, Annex to Directive 92/69/EEC (OJ No. L383A, 29.12.92), Part B, Method B.1. Acute toxicity (oral).

 

A group of ten fasted rats (five males and five females) was given a single dose by oral gavage of the test substance, as supplied, at a dose level of 2.0 g/kg bodyweight. All animals were killed and examined macroscopically on Day 15, the end of the observation  period.

 

There were no deaths. Clinical signs of reaction to treaunent comprised of piloerection, hunched posture, pallor of the extremities and increased salivation, seen in all rats. In addition, waddling gait, lethargy, decreased respiration, partially closed eyelids, unsteadiness, cold body surfaces and prostration were all less commonly observed.  Recovery was complete in all instances by Day 5.

 

A slightly low bodyweight gain was recorded for two males on Day 8, with a similar trend noted for one further male on Day 15. All other rats achieved satisfactory bodyweight gains throughout the study.

 

No abnormalities were recorded at the macroscopic examination on Day 15.

 

The acute lethal oral dose to rats of the test item was found to be greater than 2.0 g/kg bodyweight.

 

The test item will not require labelling with the risk phrase R22 "Harmful if swallowed", in accordance with Commission Directive 93/21/EEC.