Propanamide, 3-amino-2,2-dimethyl-

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:

other: Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

92/69/EWG

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1987

GLP compliance:

yes

Remarks:

ARC Seibersdorf research GmbH

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Details on test material:

- Physical state: white powder
- Analytical purity: 99.1 % (HClO4)
- Lot/batch No.: CHAD 0207
- Storage condition of test material: in the dark, at laboratory conditions

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Hygienic status: Optimal hygienic conditions.

Room temperature: Average of 21 °C (continuous control and recording).

Relative humidity: Average of 58 % (continuous control and recording).

Air exchange: 12 per hour.

Artificial light from 6 a.m. to 6 p.m.

Cages: Single caging in Makrolon cages type III (39 cm x 23 cm x 18 cm). Wire mesh lids. Sanitation of cages once a week.

Bedding material: Aspen wood chips, type "ABEDD", (Fa. ABEDD Dominik Mayr KEG,A-8580 Koeflach), autoclaved.

Feed: Altromin 1324 forte, (Producer: Altromin GmbH, D-32791 Lage) gamma irradiated with 25 kGy 60Co, ad libitum.

Water: Tap water, offered in Makrolon bottles with stainless steel canules, ad libitum.

Acclimatisation: 5 days under laboratory conditions.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Area of at least 10 % of the estimated body surface: 6 .5 cm x 8 cm (52 cm²)
Hair of the dorsal trunk was clipped one day before application.
The duration of exposure was 24 hours.
At the end of the exposure period the dressing, the tape and the patch were removed.
Residual test substance was wiped off using wet cellulose tissue, if necessary.

Duration of exposure:

24 h

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observation :0- 0.5, > 0 .5 - 1, > 1- 2, > 2 - 4 and > 4 - 6 hours after administration of the test substance (p.a.) and then at least once a day for a total of 2 weeks. Weighing was done prior to application, on day 7 and day 14 post application.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

not necessary limit test

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality or other signs of local or systemic toxicity

Mortality:

Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: Signs of toxicity related to dose levels: General findings: All animals were normal during the entire observation period.

Gross pathology:

Effects on organs:
All animals were normal at terminal necropsy.

Other findings:

Signs of toxicity (local):
Observations of skin condition: Exposed skin was not found to be altered by the test substance.