Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 609-256-3 | CAS number: 365400-11-9
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 Sep - 24 Sep 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- adopted 12 May 1987
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity: Fixed Dose Procedure)
- Version / remarks:
- adopted 9 Oct 2017
- Deviations:
- yes
- Remarks:
- The current guideline requires a Fixed Dose Procedure. However, the study was correctly conducted in accordance with an old version of the guideline as a standard acute method.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 4-[2-methanesulfonyl-4-(trifluoromethyl)benzoyl]-1,3-dimethyl-1H-pyrazol-5-ol
- EC Number:
- 609-256-3
- Cas Number:
- 365400-11-9
- Molecular formula:
- C14H13F3N2O4S
- IUPAC Name:
- 4-[2-methanesulfonyl-4-(trifluoromethyl)benzoyl]-1,3-dimethyl-1H-pyrazol-5-ol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- (HsdCpb:Wu)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan/Winkelmann GmbH, Borchen, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: approximately 9 - 13 weeks
- Weight at study initiation: males: 236 - 252 g, females: 209 - 221 g
- Fasting period before study: no fasting period
- Housing: animals were individually housed
- Diet: Provimi Kliba 3883.0.15 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
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 10 Sep 2003 To: 24 Sep 2003
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: shaven skin on the back, males: 22.5 cm2, females 20.25 cm2
- Type of wrap: the treated skin was covered with a wet gauze-layer of a "Cutiplast steril" coated with air-tight "Leukoflex" and secured in place with "Peha-Haft" cohesive stretch tape; additionally, the mobility of the rats was impaired by a "Lomir Biomedical Inc." rat jacket, which was connected with a safety pin to the stretch tape
REMOVAL OF TEST SUBSTANCE
- Washing: the treated area was cleaned with soap and water.
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (weight with unit): 2000 mg/kg bw
- Constant concentration used: yes
- For solids, paste formed: no
- Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The signs of poisoning and mortality rates were determined several times on the day of application and subsequently at least once daily for an observation period of 14 days. Body weights were determined weekly until the end of the study.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality occured and no clinical signs were noted in the course of the study.
- Mortality:
- No mortality occurred in the course of the study.
- Clinical signs:
- other: No clinical signs were noted in the course of the study.
- Gross pathology:
- During scheduled necropsy no macroscopic findings were noted.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/GHS criteria not met; no classification required according to Regulation (EC) No. 1272/2008
- Conclusions:
- The study was performed in accordance to OECD TG 402 under GLP conditions and is considered reliable. The LD50 was determined to be > 2000 mg/kg bw.
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.
