[1,2,4]Triazolo[1,5-a]pyrimidin-2-amine, 5,7-dimethoxy-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

January 11 - 14, 2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

5,7-dimethoxy-[1,2,4]triazolo[1,5-a]pyrimidin-2-amine

EC Number:

603-562-0

Cas Number:

13223-43-3

Molecular formula:

C7H9N5O2

IUPAC Name:

5,7-dimethoxy-[1,2,4]triazolo[1,5-a]pyrimidin-2-amine

Details on test material:

- Name of test material (as cited in study report): ADTP
- Physical state: off-white solid
- Analytical purity: 99.8%
- Lot/batch No.: 041206-5D
- Expiration date of the lot/batch: n/a
- Stability under test conditions: Test substance was expected to be stable for the duration of testing.
- Storage condition of test material: room temperature
- pH: 7-8 (by wetted pH paper)

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Received from Robinson Services, Inc. Clemmons, NC on December 29, 2004.
- Age at study initiation: Young adult.
- Weight at study initiation: not reported
- 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 (e.g. ad libitum): Purina Certified Rabbit Diet PMI #5322
- Water (e.g. ad libitum): Filtered tap water was supplied ad-libitum by an automatic water dispensing system.
- Acclimation period: 13 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22°C
- Humidity (%): 55-62 % RH
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Five-tenths of a gram of the test substance (0.83 g of the test mixture) was used.

VEHICLE
- Amount(s) applied (volume or weight with unit): In order to ensure adequate contact with the skin, the sample was applied as a dry paste (60% w/w mixture in distilled water). Preliminary solubility testing conducted by PSL indicated mixtures in excess of 60% (i.e., 70%-90%) were too dry to ensure adequate skin contact.

Duration of treatment / exposure:

4 hours

Observation period:

Individual dose sites were scored according to the Draize scoring system2 (see Table 3) at approximately 1, 24, 48, and 72 hours after patch removal.

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: the test substance was placed on a 1-inch x 1-inch, 4-ply gauze pad and applied to one 6-cm2 intact dose site on each animal.
- Type of wrap if used: The pad and entire trunk of each animal were then wrapped with semi-occlusive 3-inch Micropore tape to avoid dislocation of the pad. Elizabethan collars were placed on each rabbit and they were returned to their designated cages.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The pads and collars were removed and the test sites were gently cleansed of any residual test substance.
- Time after start of exposure: After 4 hours of exposure to the test substance

SCORING SYSTEM: Draize scoring system

Evaluation of Skin Reactions Value

Erythema and eschar formation:
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4

Edema formation:
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well defined by definite raising) 2
Moderate edema (raised approximately 1 millimeter) 3
Severe edema (raised more than 1 millimeter and extending beyond the area of exposure) 4

Results and discussion

In vivo

Results

Basis:

mean

Time point:

other: 24, 48 & 72 hours

Score:

0

Max. score:

0

Reversibility:

other: no irritation seen

Irritant / corrosive response data:

There was no dermal irritation observed at any treated site during this study.

Other effects:

One animal exhibited soft feces on test Day 3. The other two animals appeared active and healthy during the entire observation period

Any other information on results incl. tables

Individual irritation scores

Animal No.	Sex	Hours After Patch Removal
		1	24	48	72
13481	M	0/0	0/0	0/0	0/0
13482	M	0/0	0/0	0/0	0/0
13483	M	0/0	0/0	0/0	10
Total		0/0	0/0	0/0	0/0
Mean		0/0	0/0	0/0	0/0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study, the test substance did not cause skin irritation.

Executive summary:

A primary skin irritation test was conducted in accordance with EPA OPPTS 870.2500 (Acute Dermal Irritation) with rabbits to determine the potential for ADTP to produce irritation after a single topical application. Under the conditions of this study, the test substance did not cause skin irritation.

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.

There was no dermal irritation observed at any treated site during this study.