Registration Dossier
Registration Dossier
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EC number: 620-056-5 | CAS number: 874195-61-6
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 Feb - 14 Apr 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Ministerium für Arbeit, Gesundheit und Soziales Des Landes Nordrhein-Westfalen
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- N-[2-(4,6-dimethoxy-1,3,5-triazine-2-carbonyl)-6-fluorophenyl]-1,1-difluoro-N-methylmethanesulfonamide
- EC Number:
- 620-056-5
- Cas Number:
- 874195-61-6
- Molecular formula:
- C14H13F3N4O5S
- IUPAC Name:
- N-[2-(4,6-dimethoxy-1,3,5-triazine-2-carbonyl)-6-fluorophenyl]-1,1-difluoro-N-methylmethanesulfonamide
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Wistar; HsdCpb:Wu
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan GmbH, 5960 AD Horst, Netherlands
- Age at study initiation: 8-12 weeks old
- Weight at study initiation: for males: 273-279 g; for females: 235-251 g
- Housing: the animals were caged individually in polycarbonate cages on low dust wood granulate bedding (Lignocel BK 8-15, Firma Rettenmaier, Germany)
- Diet: standard diet "Provimi Kliba 3883 PM S15 Maus/Ratte Haltung, Kaiseraugst, Switzerland; ad libitum
- Water: tap water; ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2
- Humidity (%): 55±5
- Air changes (per hr): approx. 10 changes per hour
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 2010-03-10 To: 2010-04-24
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 6.0 cm x 5.0 cm = 30.0 cm²
- % coverage: ca. 10% of the body surface area
- Type of wrap if used: The test material was transferred to a wet gauze-layer of a "cutiplast steril" coated with air-tight "Leukoflex". The gauze strip was placed on the rat´s back and secured in place using "Peha-Haft" cohesive stretch tape and additionally covered with a "Lomir biomedical Inc rat jacket", which was connected with a safety pin to the stretch tape to ensure that the animals could not ingest the test substance.
REMOVAL OF TEST SUBSTANCE
- Washing: the area of exposure was rinsed with tepid water using soap and gently patting the area dry
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied: Depending on the body weight of the animals and the surface area on which the test substance was applied, the following dose range (mg/cm²) was applied: males: 18.2-18.6 mg/cm²; females: 15.7-16.7 mg/cm² - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs and mortality rates were determined several times on the day of application and subsequently at least once daily for the observation period. The weight gain of the animals was checked weekly until the end of the study.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- other: No clinical signs were observed during the study period.
- Gross pathology:
- The necropsies performed at the end of the study revealed no particular findings.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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