Bis(2-dimethylaminoethyl)(methyl)amine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions (limited documentation on test substance, occlusive treatment, 2 dose levels tested only)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: 40 CFR, Section 163.81-2, Federal Register, August 22, 1978 and subsequently modified in accordance with the revised EPA Pesticide Assessment Guidelines of Nov 1982

Deviations:

no

GLP compliance:

yes

Remarks:

GLP compliance statement available

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Polycat 5

IUPAC Name:

Polycat 5

Test material form:

gas under pressure: refrigerated liquefied gas

Details on test material:

Trade name of the test substance (from study report): Polycat 5
Analytical purity: no data
Lot No: AL6217-003

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Source: Perfection Breeders, Inc., Douglassville, PA 19518 (U.S.D.A. License 123-DG)
- Acclimating period: 5 days prior to exposure
- Animals housed individually, maintained in accordance with standards set forth in the Guide for the Care and Use of Laboratory Animals (DHEW Publica- tion No. 80-23).
- Temperature: 60°F - 75°F, Relative Humidity,%: 55 +/- 25, Light: 12 hour light/dark cycle
- Mean weight at study initiation: 2 - 3 kg
- Diet: Wayne 15% Rabbit Ration ad libitum
- Water: ad libitum

Administration / exposure

Type of coverage:

occlusive

Vehicle:

not specified

Details on dermal exposure:

Test site: back
Clipping of fur: 24 h before application
Area of exposure: ca. 10% of body surface
Type of wrap used: porous gauze patch wrapped with an impervious material.
Removal of the test substance: using water or an appropriate solvent, 24 h after the start of exposure

Duration of exposure:

24 hours

Doses:

200 and 1000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Rabbits (5 animals per sex/dose) were individually housed and maintained in accordance with standards set forth in the Guide for the Care and Use of Laboratory Animals (DHEW Publica- tion No. 80-23). The rabbits were acclimated to the laboratory for at least 5 days prior to dosing. healthy intact skin were used. Approximately 24 hours before testing, the fur was clipped from the backs of the test animals. Test Article was applied to approximately 10% of the body surface on each animal. The dressings were removed after 24 hours . Two dose levels were tested. The animals were observed for a 14 day period for signs of toxicity (systemic and topical) and for mortalities.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 200 - < 1 000 mg/kg bw

Based on:

test mat.

Mortality:

exposure 200 mg/kg bw (males and females) - no mortality
exposure 1000 mg/kg bw - 4/5 males, 3/5 females

Clinical signs:

other: Males: - 200 mg/kg bw - signs of necrosis on the skin in all animals - 1000 mg/kg bw - signs of necrosis on the skin in all animals, signs of diarrhea in 1 animal Females: - 200 mg/kg bw - signs of necrosis on the skin in all animals - 1000 mg/kg bw - s

Gross pathology:

Males:
- 200 mg/kg bw - no findings
- 1000 mg/kg bw - pale kidneys and liver noted for the 1/5 animals found dead on day 3. Enlarged and pale kidneys noted for 2/5 animals found dead on day 4.
Females:
- 200 mg/kg bw - no findings
- 1000 mg/kg bw - pale kidneys and liver noted for the 1/5 animals found dead on day 3. Enlarged and pale kidneys noted for 2/5 animals found dead on day 4.