Registration Dossier

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:
other: Study according OECD guideline, GLP, well documented

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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 were 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:
Pilot study: only piloerections (one male)
Main study: piloerection 1 and 3 hours after application (all animals)
Body weight:
Pilot study: normal body weights during the study
Main study: some females show stagnation in body weight increase all other rats had normal body weight gain
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:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: EU GHS EC 1272/2008
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 SAT 970 419 in rats was found to be above 5000 mg/kg b.wt.