N-cyclopropyl-1,3,5-triazine-2,4,6-triamine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

2004/10/27 to 2004/11/29

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Version / remarks:

1998

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1997

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: JMAFF 59 Nthan No. 4200

Version / remarks:

January 28, 1985

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-cyclopropyl-1,3,5-triazine-2,4,6-triamine

EC Number:

266-257-8

EC Name:

N-cyclopropyl-1,3,5-triazine-2,4,6-triamine

Cas Number:

66215-27-8

Molecular formula:

C6H10N6

IUPAC Name:

N2-cyclopropyl-1,3,5-triazine-2,4,6-triamine

Test material form:

solid: particulate/powder

Remarks:

white to light beige crystalline

Test animals

Species:

rat

Strain:

Sprague-Dawley

Remarks:

albino

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: Young adult (8—9 weeks)
- Weight at study initiation: Males 266-284 grams and females 192-200 grams
- Housing: The animals were singly housed in suspended stainless steel caging with mesh floors which conform to the size recommendations in the most recent Guide for the Care and Use of Laboratory Animals DHEW(NIH). Litter paper was placed beneath the cage and was changed at least three times per week.
- Diet: Rodent feed
- Water: Filtered tap water was supplied ad-libitum by an automatic water dispensing system.
- Acclimation period: 9 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23°C
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle

Administration / exposure

Type of coverage:

occlusive

Vehicle:

other: distilled water

Details on dermal exposure:

TEST SITE
- Area of exposure: The dorsal area and the trunk
- % coverage: Approximately 10%
- Type of wrap if used: Occlusive 3-inch Durapore tape

REMOVAL OF TEST SUBSTANCE
- Washing: The test sites were gently cleansed with water to remove any residual test substance.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount applied: 2000 mg/kg bw
- For solids, paste formed: yes

VEHICLE
Prior to application, the test substance was moistened with distilled water to achieve a dry paste by preparing a 75% w/w mixture.

Duration of exposure:

24 hours

Doses:

Single dose: 2,000 mg/kg bw

No. of animals per sex per dose:

5 animals/sex/dose

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 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. Body weights were recorded prior to application and again on Days 7 and 14 (termination).
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

no indication of skin irritation up to the relevant limit dose level

Mortality:

No mortality occurred.

Clinical signs:

other: All animals appeared active and healthy during the study.

Gross pathology:

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.

Any other information on results incl. tables

Results are provided in the overall remarks section below.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study, the acute dermal LD50 of Cyromazine is greater than 2,000 mg/kg of body weight in male and female rats.

Executive summary:

An acute dermal toxicity test was conducted with rats to determine the potential for Cyromazine to produce toxicity from a single topical application. Two thousand milligrams per kilogram of body weight of the test substance was moistened with distilled water and applied to the skin often healthy rats for 24 hours. The animals were observed for mortality, signs of gross toxicity, and behavioral changes at least once daily for 14 days. Body weights were recorded prior to application and again on Days 7 and 14 (termination). Necropsies were performed on all animals at terminal sacrifice.

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. The results show that the acute dermal LD50 of the test substance is greater than 2,000 mg/kg of body weight in male and female rats.