Dimethyl(propyl)amine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1999

Reliability:

1 (reliable without restriction)

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1984

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

1992

Deviations:

no

Test guideline 3

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

Test material information

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:

dimethyl(propyl)amine

Specific details on test material used for the study:

- Lot/batch No.: K322/1

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

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no mortality occurred.

Clinical signs:

other: Neither clinical symptoms of toxicity nor local skin reactions could be evidenced.

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

Conclusions:

The substance 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 LD50 for acute dermal toxicity was > 2000 mg/kg bw for male and female rats.