N,N-dimethyldecan-1-amide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N,N-dimethyldecan-1-amide

EC Number:

238-405-1

EC Name:

N,N-dimethyldecan-1-amide

Cas Number:

14433-76-2

Molecular formula:

C12H25NO

IUPAC Name:

N,N-dimethyldecanamide

Details on test material:

- Name of test material (as cited in study report): SAT 970 419, Decansäuredimethylamid
- Chemical name: N,N-Dimethyldecan-1-amide
- Physical state: liquid
- Lot/batch No.: Ch. 1/96
- Expiration date of the lot/batch: June 1998
- Storage condition of test material: room temperature, darkness

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Tierzucht Schönwalde GmbH, Schönwalde, Germany
- Weight at study initiation: weight on dosing day 192-252g
- Fasting period before study: not fasted prior dosing
- Housing: animal room 4, filtered air, transparent polycarbonate cages (macrolonge type III), two or three rats per cage
- Diet (e.g. ad libitum): Altromin 1314 (Altromin, Lage, Germany) ad libitum
- Water (e.g. ad libitum): ad libitum (acified pH=2.5 with HCl)
- Acclimation period: 36 days (female), 8 days (male)


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±3°C
- Humidity (%): 55±15%
- Air changes (per hr): 10 times/h
- Photoperiod (hrs dark / hrs light): 12h each

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: 5*6cm
- coverage: 4-layer gauze
- Type of wrap if used: Micropore tape wounded around the trunk

REMOVAL OF TEST SUBSTANCE
- Washing (if done): sponged with lukewarm water
- Time after start of exposure: 24h

TEST MATERIAL
- Constant volume or concentration used: constant dose of 5000mg/kg b.wt.

Duration of exposure:

24h

Doses:

Pilot study: 2000 and 5000 mg/kg b.wt.
Main study: 5000 mg/kg b.wt.

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

according to guideline

Statistics:

no

Results and discussion

Preliminary study:

Pilot study: no abnormalities observed at the animal dosed with 2000 mg/kg b.wt.
piloerection was observed at the animal dosed with 5000 mg/kg b.wt.
Therefore main study was accomplished with 5000 mg/kg b.wt.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

Pilot study: no deaths observed
Main study: no deaths observed

Clinical signs:

other: Pilot study: only piloerections (one male) Main study: piloerection 1 and 3 hours after application (all animals)

Gross pathology:

Pilot study: post mortem inspection revealed no abnormalities
Main study: post mortem inspection revealed no abnormalities

Other findings:

not stated

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the experimental conditions the dermal LD50 of N,N-Dimethyldecan-1-amide in rats was found to be above 5000mg/kg b.wt.

Executive summary:

The acute dermal toxicity of N,N-Dimethyldecan-1-amide in rats was determined according to the method recommended in the OECD Guideline No. 402 "Acute Dermal Toxicity", Feb. 1987, and the corresponding EEC GuidelineB.3 "Acute Toxicity (Dermal)", 29.12.92.

The study was performed as a limit test with 10 Wistar rats (five males and five females). The rats were exposed to a single dermal dose of 5000 mg/kg b.wt. for 24 hours followed by an observation period of 14 days. During the study clinical signs of reaction to the treatment were recorded daily. Body weight was recorded once a week. After the two week observation period the animals were killed and subjected to a gross necropsy examination.

All animals in the main study survived the treatment and showed very slight signs of toxicity.

Under the experimental conditions described in this report, the dermal LD50 of the test substance in rats was found to be above 5000 mg/kg b.wt.