Propanamide, 2-hydroxy-N,N-dimethyl-

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2006-11-22 to 2006-12-13

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and guideline compliant study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

(Feb, 1987)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

(July 1992)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-hydroxy-N,N-dimethylpropanamide

EC Number:

609-066-0

Cas Number:

35123-06-9

Molecular formula:

C5H11NO2

IUPAC Name:

2-hydroxy-N,N-dimethylpropanamide

Test material form:

other: liquid

Test animals

Species:

rat

Strain:

other: HanRcc:WIST (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: RCC Ltd, Laboratory Animal Services CH-4414 Füllinsdorf / Switzerland
- Age at study initiation: Males: 8 weeks, Females: 11 weeks
- Weight at treatment day: 196-256 g
- Fasting period before study: No
- Housing: In groups of five per sex
- Diet: Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, ad libitum.
- Water: Community tap water from Füllinsdorf, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 30-70 %
- Air changes: 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: Backs of the animals
- % coverage: Approximately 10 % of the total body surface
- Type of wrap if used: Elastic adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing: Lukewarm tap water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 mL
- Concentration: 2000 mg/kg
- Constant volume or concentration used: Yes
- For solids, paste formed: Yes

Duration of exposure:

24 hours

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

5 males and 5 females

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily during the acclimatization period, during the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15. Weighing: On test days 1 (prior to administration), 8 and 15
- Necropsy of survivors performed: Yes
- Other examinations performed: Mortality/viability, clinical signs, body weight, local signs

Statistics:

No statistical analysis was used.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred during the study.

Clinical signs:

other: No systemic signs of toxicity were observed during the study period. Local signs of irritation were noted at the application site of all animals except one female. A slight erythema was noted in the five males and four females. In addition, all males and

Gross pathology:

No macroscopic findings were observed at necropsy.