Registration Dossier
Registration Dossier
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EC number: 918-208-3 | CAS number: -
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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- other: 870.1000 "Acute toxicity testing background"
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- not available
- Molecular formula:
- C12 H16 Cl NO2 HCl
- IUPAC Name:
- not available
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
- Specific details on test material used for the study:
- 2-(ter-butylamino)-1-(3-chloro-4-hydroxyphenyl)ethanone HCl
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- physiological saline
- Doses:
- 2000mg/kg
- No. of animals per sex per dose:
- 3 rats for step (2 steps)
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 2 000 - <= 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality
- Clinical signs:
- animal 1- step 1: 20, 30, 45, 60 as well as 80 min post-dose: slight reduced spontaneous activity, apathy. 1 day post-dose: no signs of toxicity.animal 2 and 3 - step 1: 30, 60 as well as 120 min post-dose: apathy. 1 day post-dose: no signs of toxicity.No other treatment related effects observed in any animals.
- Gross pathology:
- No treatment related effects observed in any animals.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The product showed slight oral toxic characteristicsAccording to GHS the substance was classified into Category 5 (LD50 cut-off: >2000 to 5000 mg/kg bw)
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