Registration Dossier

Toxicological information

Skin irritation / corrosion

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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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Qualifier:
according to
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;
Qualifier:
according to
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 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

Resultsopen allclose all
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
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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Applicant's summary and conclusion