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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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.3 (Acute Toxicity (Dermal))

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
- Age at study initiation: 7 to 10 weeks
- Weight at study initiation: 235 to 278g
- Housing: individually 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: 25 days prior to the start of the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30 - 70%
- Air changes (per hr): 10 to 15 per hour
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light (07:00 - 19:00 hours) in each 24-hour period.

Administration / exposure

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 50 mm x 50 mm)
- % coverage: 10% of the total body surface
- The treated area was then promptly covered with gauze which was held in place with a non-irritative dressing encircled firmly around the trunk.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): carefully removed and the treated area of skin was washed with warm (30° to 40°C) water and blotted dry with absorbent paper.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.0 g/kg bodyweight.

Duration of exposure:

24 hours with 14 days observation period

Doses:

2.0 g/kg bw

No. of animals per sex per dose:

5 (five males and five females)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
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 approximately 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

Bodyweight
Individual bodyweights were recorded on Days 1 (prior to dosing), 8 and 15. Individual weekly bodyweight changes and group mean bodyweights were calculated.

- Necropsy of survivors performed: yes

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 dermal application 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: There were no signs of systemic reaction to treatment

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 dermal 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 dermal 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.3. Acute toxicity (dermal).

 

A group of ten rats (five males and five females) was given a single dermal application of the test substance, as supplied, at a dosage 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 and no signs of systemic reaction to  treatment.

Desquamation was noted in four females during the early part of the study, accompanied in one animal by transient slight dermal irritation (erythema only) on Day 3. All other sites of application of the test item showed no irritation or other dermal  changes.

 

Slightly low bodyweight gains were recorded for three males on Day 8 with a similar trend noted for three males and three females on Day 15. In addition, zero bodyweight gain was recorded for two females on Day 8, with one further female showing a slight bodyweight loss at this time. All other rats achieved satisfactory bodyweight gains throughout thestudy.

 

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

 

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 R21 "Harmful in contact with skin", in accordance with Commission Directive 93/21/EEC.