Pyrimidine-2,4,6-triyltriamine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1980

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

May 1981

Deviations:

yes

Remarks:

Reading after 4 hours of exposure, occlusive dressing, grading of skin reactions not specified

GLP compliance:

no

Remarks:

pre-GLP

Test material

Test material information

Constituent 1

Reference substance name:

Pyrimidine-2,4,6-triyltriamine

EC Number:

213-720-7

EC Name:

Pyrimidine-2,4,6-triyltriamine

Cas Number:

1004-38-2

Molecular formula:

C4H7N5

IUPAC Name:

2,4,6-Triaminopyrimidine

Test material form:

solid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source: Lonza AG
- Purity: 98.7%
- Melting point: 254-256.5°C

Test animals

Species:

rabbit

Strain:

other: albino

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:
- Age at study initiation:
- Weight at study initiation:
- Housing:
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 g

VEHICLE
- Amount applied: 0.5 ml
- Vehicle used: distilled water

Duration of treatment / exposure:

4 h

Observation period:

48 h

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 1 inch by 1 inch
- Type of wrap if used: gauze

REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 4 h

SCORING SYSTEM:
- Method of calculation: Irritation index

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 4 h

Score:

1

Reversibility:

fully reversible within: 1 day

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

24/48/72 h

Score:

0.1

Max. score:

8

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

other: 4 h

Score:

1

Reversibility:

fully reversible within: 1 day

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Animals No. 1 and No. 6 showed very slight erythema/eschar at the first reading (4 h). Very slight erythema was observed at the intact site of ne animal and the abraded site of the other animal. The score was set to 1. At the next reading (24 h), the slight reaction was not observed. No other animal experienced any adverse effects. Thus, the sum of readings (4, 24, and 48 h) of 2 was used to calculate the irritation index (Sum of readings/18). An irritation index of 0.1 was calculated (2/18). The classification of irritancy is displayed in "any other information on results."

Any other information on results incl. tables

Table 1: Irritation index and corresponding classification of irritant potential

Irritation index	Classification of irritancy
0 – 0.2	Non-irritant
>0.2 – 2	Mild irritant
>2 – 5	Moderate irritant
>5 – 8	Severe irritant

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance is not considered to be corrosive to rabbit skin. Evidence of very slight transient irritation was observed in two animals only.

Executive summary:

To investigate the skin irritation potential of the test substance, six albino rabbits were treated with 0.5 g applied under a gauze pad which was moistened with 0.5 ml distilled water to two intact sites on the clipped dorsum. Numerical scores for erythema and edema were recorded for each animal. Readings were performed at 4, 24, 48, and 72 hours. Four animals did not show any observable response to treatment throughout the observation period. Two animals had very slight erythema observed at the intact site of one animal and at the abraded site of the other animal at the 4 h reading only. A primary irritation index of 0.1 was calculated and thus, the test substance was concluded to be non-irritant to rabbit skin.