Registration Dossier
Registration Dossier
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EC number: 247-865-2 | CAS number: 26638-53-9
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. Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- The study was carried out based on the guidelines described in:
OECD No.423 (2001) "Acute Toxicity-Oral, Acute Toxic Class Method"
Commission Regulation (EC) No 440/2008, B1 tris: "Acute Oral Toxicity, Acute Toxic Class Method"
EPA, OPPTS 870.1100 (2002), "Acute Oral Toxicity - Acute Toxic Class Method"
JMAFF guidelines (2011) including the most recent partial revisions. - Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
Test material
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Propylene glycol (Merck, Darmstadt, Germany) (specific gravity 1.036)
- Doses:
- 2000 mg/Kg
- No. of animals per sex per dose:
- 3 females
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Conclusions:
- The oral LD50 value of 1574 CETONA in Wistar rats was established to exceed 2000 mg/kg body
weight.
According to the OECD 423 test guideline and based on the LD50 cut-off values, the LD50 value was considered to exceed 2000 mg/kg body weight.
Based on these results, 1574 CETONA does not have to be classified and has no obligatory labelling requirement for acute oral toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures, including all amendments.
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.
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