Registration Dossier
Registration Dossier
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EC number: 611-342-0 | CAS number: 55974-25-9
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD 401) but full details are not available. There the reliability is with restrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 7-methoxy-4,4-dimethyl-3,4-dihydro-1H-2-benzopyran-1,3-dione
- EC Number:
- 611-342-0
- Cas Number:
- 55974-25-9
- Molecular formula:
- C12 H12 O4
- IUPAC Name:
- 7-methoxy-4,4-dimethyl-3,4-dihydro-1H-2-benzopyran-1,3-dione
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Isochroman puro
- Physical state: powder
- Lot/batch No.: 01002
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- not specified
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 24 - 26 g
- Diet (e.g. ad libitum): Conventional feeding
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 25
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 : 12
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Doses:
- 2000 mg / 1000 g body weight
- No. of animals per sex per dose:
- 5 male per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations : 1 - 4 hours after application and once daily on Day 1, 2, 3 ,4, 7 and 14
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 665 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Male, 2000 mg/kg bw, Number of animals 5 ; Number of death 2 , within 4 hours after application
Male, 2000 mg/kg bw, Number of animals 3 ; Number of death 1 , within 1 day after application - Clinical signs:
- other: The survival mice were affected on its mobility and vitality.
- Gross pathology:
- No data
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- In conclusion, according to the Globally Harmonized Classification System, Isochroman puro administered orally at a dose level of 2000 mg/kg body
weight in male rats under the conditions of this study is considered to be a category 4 test article ( i.e., the oral LD50 in rats
is 1665 mg/kg bw ).
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