Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 253-575-7 | CAS number: 37640-57-6
Toxicological information
Skin irritation / corrosion
Currently viewing:
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:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- 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;
- 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 substance name:
- 1,3,5-triazine-2,4,6(1H,3H,5H)-trione, compound with 1,3,5-triazine-2,4,6-triamine (1:1)
- EC Number:
- 253-575-7
- EC Name:
- 1,3,5-triazine-2,4,6(1H,3H,5H)-trione, compound with 1,3,5-triazine-2,4,6-triamine (1:1)
- Cas Number:
- 37640-57-6
- Molecular formula:
- C3H6N6.C3H3N3O3
- IUPAC Name:
- 1,3,5-triazinane-2,4,6-trione - 1,3,5-triazine-2,4,6-triamine (1:1)
- Test material form:
- solid: particulate/powder
Constituent 1
- 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
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
-
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
