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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 930-430-2 | CAS number: 1383692-20-3
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to EU/OECD-guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 1-difluoromethanesulfonyl-3-(4,6-dimethoxy-1,3,5-triazin-2-yl)-7-fluoro-1H-indol-2-ol
- EC Number:
- 930-430-2
- Cas Number:
- 1383692-20-3
- Molecular formula:
- C14H11F3N4O5S
- IUPAC Name:
- 1-difluoromethanesulfonyl-3-(4,6-dimethoxy-1,3,5-triazin-2-yl)-7-fluoro-1H-indol-2-ol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 female animals, 3 animals/group
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- One female animal was found dead after treatment with the test item at the dose level of 2000 mg/kg bw. Specific cause of death was not determined for this animal.
- Clinical signs:
- other: Clinical signs were observed in animals treated at 2000 mg/kg bw with test item. These included hunched back (3/6), piloerection (1/6) and death (1/6). The surviving animals became symptom-free from 6 hours until the end of the observation period.
- Gross pathology:
- On the dead animal treated at 2000 mg/kg bw enlargement of the liver was found at necropsy. Various organs/tissues were cannibalized including the tongue, eye and optic nerve, mandibular lymph node, salivary gland, larynx, thyroid and parathyroid gland, trachea, esophagus, thymus, heart, lungs, brain, pituitary, harderian gland, lacrimal gland and nasal cavity. A specific cause of death was not determined for this animal.
No macroscopic observations were seen in surviving rats dosed at 2000 mg/kg bw and necropsied on Day 14.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the acute oral LD50 value of the test item was found to be above 2000 mg/kg bw in female RccHan:WIST rats.
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.
