1,3,5-triazine-2,4,6(1H,3H,5H)-trione, compound with 1,3,5-triazine-2,4,6-triamine (1:1)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (GLP, QUA)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: US FDA Title 21 Code of Federal Regulations Part 58; US EPA (FIFRA), Title 40 Code of Federal Regulations Part 160; US EPA (TSCA), Title 40 Code of Federal Regulations Part 792;

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japanese Ministry of Agriculture, Forestry and Fisheries, 59 NohSan, Notifications No.3850; Japanese Ministry of International Trade and Industry, Kanpogyo No.39 Environmental Agency, Kikyoku No.85; Japanese Ministry of Health and Welfare, Ordinance No.21

GLP compliance:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

- Name of test material (as cited in study report): FR-6120
- Physical state: white powder
- Analytical purity: ca. 99.5%
- Impurities (identity and concentrations): water (0.27%), Melamine (0.19%) and cyanuric acid (0.012%) (weight%)
- Purity test date: 04 May 2000
- Lot/batch No.: 37432-18-3
- Expiration date of the lot/batch: 22 May 2001
- Stability under test conditions: not indicated
- Storage condition of test material: at room temperature in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Albino Rabbit, New Zealand White, (SPF-Quality) from Charles River Deutschland, Kisslegg, Germany.
- Age at study initiation: 6 weeks
- Weight at study initiation: less than 3.5 kg (mean bw: 1.529 kg)
- Housing: Individually housed in labelled cages with perforated floors (Scanbur, Denmark) and equipped with an automatic drinking system (ITL, Bergen, The Netherlands)
- Diet (e.g. ad libitum): standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Germany) approx. 100 g. per day.
- Water (e.g. ad libitum): free access to tap-water.
- Acclimation period: at least 5 days before start of treatment under laboratory conditions

ENVIRONMENTAL CONDITIONS
A controlled environment was maintained in the room with optimal conditions
- Temperature (°C): 21°C
- Humidity (%): 50%
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light and 12 hours dark per day

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: the powdery test substance was moistened with water (Milli-U), immediately before application, to ensure close contact with the animal's skin.

Controls:

other: adjacent areas of the untreated skin of each animal served as controls

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

VEHICLE
- Amount(s) applied (volume or weight with unit): the test substance was moistened with 0.5 ml of the vehicle

Duration of treatment / exposure:

4 hours

Observation period:

up to 72 hours after test substance application

Number of animals:

3 animals of one sex (males)

Details on study design:

TEST SITE
- Area of exposure: ca 24 hours before treatment, the dorsal fur was clipped with electric clippers, exposing an area of approximately 150 square centimeters (10x15 cm2).
- Type of wrap if used: the test compound was applied to the skin of one flank, using a metalline patch" of 2x3 cm. The patch was mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the dressing was removed and the skin cleaned of residual test substance using water
- Time after start of exposure: 4 hours after application

SCORING SYSTEM: the irritation was assessed according to the OECD numerical scoring system. Whenever considered necessary the treated skin areas were re-clipped at least 3 hours before the observations, to facilitate scoring. The results were evaluated according to the EC criteria for classification and labeling requirements for dangerous substances and preparations.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of all tested animals

Time point:

other: 24-48-72-hour

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: an erythema score of 0 was observed in each animal at all observation time points

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

of all tested animals

Time point:

other: 24-48-72-hour

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: an edema score of 0 was observed in each animal at all observation time points

Irritant / corrosive response data:

No skin irritation or corrosion was caused by 4 hours exposure to the test substance

Other effects:

- Coloration: no staining of the treated skin by the test substance was observed.
- Toxicity / Mortality: No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Any other information on results incl. tables

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