6-methyl-1,3,5-triazine-2,4-diyldiamine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1989-10-31 till 1989-11-03

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Reliable without restrictions; Guideline study (OECD 404; Irritant effects on rabbit skin) according to GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,4-Diamino-6-methyl-1,3,5-triazine

IUPAC Name:

2,4-Diamino-6-methyl-1,3,5-triazine

Constituent 2

Reference substance name:

6-methyl-1,3,5-triazine-2,4-diyldiamine

EC Number:

208-796-3

EC Name:

6-methyl-1,3,5-triazine-2,4-diyldiamine

Cas Number:

542-02-9

Molecular formula:

C4H7N5

IUPAC Name:

6-methyl-1,3,5-triazine-2,4-diamine

Details on test material:

- Name of test material (as cited in study report): Acetoguanamine
- Physical state: solid (white powder)
- Analytical purity: 99.2 %
- Lot/batch No.: 10/08/89 AG

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Froxfield Farms (U.K.) Ltd., Petersfield, Hampshire, England
- Age at study initiation: approx. 12 weeks
- Weight at study initiation: 2.5 - 2.7 kg
- Housing: idividually in metal cages with perforated floors.
- Diet (e.g. ad libitum): SDS Standard Rabbit Diet (ad libitum)
- Water (e.g. ad libitum): tap water (ad libitum)
- Acclimation period: "the rabbit selected were all acclimated to the laboratory environment", but no data on time period.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx. 19 °C
- Humidity (%): 30-70 %
- Air changes (per hr): approx. 19 per hour
- Photoperiod (hrs dark / hrs light): lighting was controlled by means of a time switch to give 12 hours of artificial light (0700-1900 hours) in each 24 hours period.

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): 0.5 g Acetoguanamine

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL distilled water
- Lot/batch no. (if required): 10/08/89 AG
- Purity: 99.2 %

Duration of treatment / exposure:

four hours

Observation period:

Examintation of the treated skin was made on Day 1 (i.e. approximately 30 minutes after removal of the patches) and on Days 2, 3 and 4.

Number of animals:

three

Details on study design:

TEST SITE
- Area of exposure: dorso-lumbar region
- Type of wrap if used: 2.5 cm square gauze pad

REMOVAL OF TEST SUBSTANCE
- Washing (if done): treatment site was washed using water to remove any residual test substance
- Time after start of exposure: four hours

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

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

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 30 minutes after removal of the patches and on days 2, 3 and 4

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 30 minutes after removal of the patches and on days 2, 3 and 4

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 30 minutes after removal of the patches and on days 2, 3 and 4

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 30 minutes after removal of the patches and on days 2, 3 and 4

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 30 minutes after removal of the patches and on days 2, 3 and 4

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 30 minutes after removal of the patches and on days 2, 3 and 4

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

The treated skin of all three animals was scored for erythema and oedema. The test substance caused no adverse effects to the skin.

Other effects:

None of the animals showed any response to treatment throughout the observation period.

Any other information on results incl. tables

Table 1: Dermal reactions elicited by Acetoguanamine.

Rabbit Number and Sex	Bodyweight (Day 1)	E = Erythema O = Oedema	Day
			1*	2	3	4
803 (female)	2525 g	E O	0 0	0 0	0 0	0 0
804(female)	2650 g	E O	0 0	0 0	0 0	0 0
805(female)	2670 g	E O	0 0	0 0	0 0	0 0

* Approximately 30 minutes after removal of the dressing

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: EEC Directive 83/467/EEC Annex VI Part II

Conclusions:

In a dermal irritation study according to OECD 404 three New Zealand White strain rabbits were semi-occlusive dermally exposed to 0.5 g Acetoguanamine for four hours. Examination of the treated skin was made on Day 1 (i.e. approx. 30 minutes after removal of the test substance) and on Day 2, 3 and 4. None of the animals showed any response to treatment throughout the observation period.
Therefore no classification for skin irritation is required for Acetoguanamine.

Executive summary:

In a dermal irritation study according to OECD 404 three New Zealand White strain rabbits were semi-occlusive dermally exposed to 0.5 g of Acetoguanamine for four hours. Examination of the treated skin was made on Day 1 (i.e. approx. 30 minutes after removal of the test substance) and on Day 2, 3 and 4. None of the animals showed any response to treatment throughout the observation period. Therefore no classification for skin irritation is required for Acetoguanamine.