Ametryn

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study in compliance with guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Ametryn

EC Number:

212-634-7

EC Name:

Ametryn

Cas Number:

834-12-8

Molecular formula:

C9H17N5S

IUPAC Name:

N2-ethyl-6-(methylsulfanyl)-N4-(propan-2-yl)-1,3,5-triazine-2,4-diamine

Details on test material:

Batch Identification: FLC41 050
Product design Code: G34162
Product Common Name: Ametryn
Purity: 97.7% (wt/wt)
Appearance: white powder

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Age/Body weight: Young adult (9-10 weeks)/males 314-336 grams and females
215-237 grams at experimental start.
Source: Received from Ace Animals, Inc., Boyertown, PA on September 7,
2004.

Housing: The animals were singly housed in suspended stainless steel caging with mesh floors Litter paper was placed beneath the cage and was changed at least three times per week.
Animal Room Temperature Range: 19-23°C
Photoperiod: 12-hour light/dark cycle
Acclimation Period: 14 days
Food: Purina Rodent Chow #5012
Water: Filtered tap water was supplied ad-libitum by an automatic water dispensing system.
Contaminants: There were no known contaminants reasonably expected to be found in the food or water at levels which would have interfered with the results of this study.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

On the day prior to application, a group of animals was prepared by clipping the dorsal area and the trunk. After clipping and prior to application, the animals were examined for health, weighed (initial) and the skin checked for any abnormalities.

Individual doses were calculated based on the initial body weights, taking into account the concentration of the test mixture.

Prior to application, the test substance was moistened with distilled water to achieve a dry paste by preparing a 60% w/w mixture. Two thousand mg/kg of body weight of the test substance was then applied to a 2 inch x 3 inch, 4-ply gauze pad and placed on a dose area of approximately 2 inches x 3 inches (approximately 10% of the body surface). The gauze pad and entire trunk of each animal were then wrapped with an occlusive 3-inch Durapore tape to avoid dislocation of the pad and to minimize loss of the test substance. The rats were then returned to their designated cages. The day of application was considered Day 0 of the study.
After 24 hours of exposure to the test substance, the pads were removed and the test sites were gently cleansed with water to remove any residual test substance.

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 Males and 5 Females. Females assigned to test were nulliparous and nonpregnant.

Control animals:

no

Details on study design:

Individual body weights of the animals were recorded prior to test substance application (initial) and again on Days 7 and 14 (termination).

The animals were observed for mortality, signs of gross toxicity, and behavioral changes during the first several hours after application and at least once daily thereafter for 14 days. Observations included gross evaluation of skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behavior pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhea and coma.

All rats were euthanized via CO2 inhalation on Day 14. Gross necropsies were performed on all animals. Tissues and organs of the thoracic and abdominal cavities were examined.

Statistics:

no data

Results and discussion

Preliminary study:

not applicable

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

see remarks on results

Clinical signs:

other: see remarks on results

Gross pathology:

see remarks on results

Other findings:

see remarks on results

Any other information on results incl. tables

All animals survived, gained body weight, and appeared active and healthy during the study. There were no signs of gross toxicity, dermal irritation, adverse pharmacologic effects or abnormal behavior. No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU