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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1999
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
1984
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
1992
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Version / remarks:
1998
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Dimethyl(propyl)amine
EC Number:
213-139-9
EC Name:
Dimethyl(propyl)amine
Cas Number:
926-63-6
Molecular formula:
C5H13N
IUPAC Name:
N,N-dimethylpropan-1-amine
Constituent 2
Reference substance name:
Dimethyl-n-propylamine
IUPAC Name:
Dimethyl-n-propylamine
Details on test material:
- Name of test material (as cited in study report): Dimethylpropylamine
- Physical state: liquid, colourless, clear
- Analytical purity: 99.4% (Gas chromotography; BASF AG, Analytical Department)
- Lot/batch No.: K 322/1
- Storage condition of test material: room temperature, under N2

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Strain as cited in study report: chbb: thom (SPF)
- Source: Boehringer Ingelheim Pharma KG
- Age at study initiation: young adult animals
- Weight at study initiation: 200-300 g
- Housing: single housing in stainless steel wire mesh cages, type DK-III (Becker & Co., Castrop-Rauxel, FRG)
- Diet: Kliba-Labordiet (Provimi Kliba SA, Kaiseraugst, Switzerland), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark/hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 50 cm2
- % coverage: 10
- Type of wrap if used: semi-occlusive dressing consisting of four layers absorbent gauze and Fixomull stretch (adhesive fleece)
- Fur was clipped 24 hrs before study begin

REMOVAL OF TEST SUBSTANCE
- Washing: after removal of the dressing, the application site was rinsed with warm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Application volume: 2.78 mL/kg bw
- Density: 0.719 g/mL
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
DURATION OF OBSERVATION PERIOD
14 days
FREQUENCY OF OBSERVATIONS FOR MOTALITY AND CLINICAL SYMPTOMS
A check for any dead or moribund animal was made twice each workday and once on Saturdays, Sundays and on public holidays. Clinical symptoms were recorded several times on the day of administration and at least once per workday thereafter.
FREQUENCY OF WEIGHING
Individual body weights were recorded shortly before exposure (day 0), weekly thereafter, and finally before the sacrifice of the animals at the end of the observation period.
SKIN FINDINGS
Individual examination of skin was done between 3 to 60 minutes after removal of the dressing (i.e., day 1), weekly thereafter, and at the end of the observation period. The findings were scored according to the Draize scoring system (Draize, JH, Appraisal of the safety of chemicals in foods, drugs and cosmetics. The association of food and drug officials of the United States Austin,Texas, 1959).
NECROPSY
At the end of the observation period the surviving animals were sacrificed with CO2-inhalation and were subjected to gross pathological examination as well as the animal which died before.
Statistics:
The binomial test (Snedecor GW and Cochran WG, Statistical methods, 8th ed., Iowa State University Press/Ames, 1989) was used.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality, symptoms, local effects
Mortality:
no mortality occurred.
Clinical signs:
Neither clinical symptoms of toxicity nor local skin reactions could be evidenced.
Body weight:
Body weights and body weight gain were as expected and thus, inconspicuous.
Gross pathology:
At necropsy, gross pathology revealed no abnormalities.

Any other information on results incl. tables

Body weight data:

Animals

Individual body weights (g)

Sex

Number

Day 0

Day 7

 Day 13

Males

1

279

304

333

2

276

296

322

3

280

308

346

4

276

298

328

5

276

301

329

Females

1

229

219

226

2

229

241

248

3

230

225

250

4

227

224

241

5

234

234

240

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

Dimethylpropylamine was tested for acute dermal toxicity in rats in a limit test conducted according to the OECD TG 402 (1987). The study conduct was GLP conform. The test item was applied at 2000 mg/kg bw onto the clipped skin of each of 5 male and 5 female animals, under semi-occlusive conditions for 24 hours.

Neither mortality nor clinical symptoms of toxicity were observed. No skin reactions were noticed. Body weights and body weight gain were as expected, and at necropsy, gross pathology revealed no abnormalities. Therefore the LD0 for acute dermal toxicity was > 2000 mg/kg bw for male and female rats.