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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2004/05/19 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:

other: JMAFF 59 Nthan No. 4200

Version / remarks:

January 28, 1985

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Version / remarks:

1998

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

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:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: Young adult
- 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: Pelleted rabbit feed
- Water: Filtered tap water was supplied ad-libitum by an automatic water dispensing system.
- Acclimation period: 13 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21°C
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

other: distilled water

Amount / concentration applied:

0.5 gram (0.67 g of the test mixture)

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

2 males and 1 female

Details on study design:

TEST SITE
- Area of exposure: dorsal area and the trunk
- Type of wrap if used: semi-occlusive 3 inch Micropore 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: After 4 hours

OBSERVATION TIME POINTS : 1, 24, 48, and 72 hours

SCORING SYSTEM: Individual dose sites were scored according to the Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Any other information on results incl. tables

All animals appeared active and healthy. Apart from the skin irritation, there were no other signs of gross toxicity, adverse pharrnacologic effects or abnormal behavior. One hour after patch removal, very slight erythema was noted for all three treate sites. All animals were free from dermal irritation within 24 hours.

Results are provided in the overall remarks section below.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of an in vivo skin irritation study performed according to OECD/EC guidelines and under GLP, cyromazine was concluded to be not irritant to the skin.

Executive summary:

A primary skin irritation test was conducted with rabbits to determine the potential for Cyromazine to produce irritation after a single topical application. Five-tenths of a gram of the test substance was moistened with distilled water and applied to the skin of three healthy rabbits for 4 hours. Following exposure, dermal irritation was evaluated by the method of Draize et al. One hour after patch removal, very slight erythema was noted for all three treated sites. All animals were free from dermal irritation within 24 hours. Based on these results cyromazine was concluded to be not irritant to the skin.