Registration Dossier
Registration Dossier
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EC number: 604-144-0 | CAS number: 139525-77-2
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- No details of the method, procedure and results.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 604-144-0
- EC Number:
- 604-144-0
- Cas Number:
- 139525-77-2
- Molecular formula:
- C13H15NO.HCl
- IUPAC Name:
- 604-144-0
- Test material form:
- solid: particulate/powder
- Details on test material:
- White powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Rat from breeding center IFFA/CREDO (Saint-Germain sur l'Arbresle - France)Mean Wieght : 150 gAge : 7 weeks
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: gommi arabicum
- Details on oral exposure:
- The substance is suspended in a 5% of solution of gommi arabicum using a homogenizer. It is administered at 10 am (1 ml for 100 g of bodyweight)
- Doses:
- Not specified
- No. of animals per sex per dose:
- Not specified
- Control animals:
- yes
- Remarks:
- with gommi arabicum (5%) - 1 ml for 100 g
- Details on study design:
- T° : 22°C +/- 2°CLighting is artificial : 12 hours light, 12 hours darkThe animals are randomly selected and kept in their cages for at least 5/6 days prior to the start of dosing to allow for acclimatisation to the laboratory conditions.Animals are group-caged by doseFood and water ad. libitumObservation during 14 days. All rats were weighed before the treatment and the 3, 7, 10 and 14 day after the treatment.
- Statistics:
- Bliss model
Results and discussion
Effect levels
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 1 205.74 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 1 161.73 - < 1 251.42
- Mortality:
- Yes but the number is not specified
- Clinical signs:
- For the survivors, a sedative effect was observed which disappears after 2 days
- Body weight:
- No variation
- Gross pathology:
- Not specified
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The LD50 of the mephtamin (CAS : 139525-77-2) is 1205 mg/kgbw.
- Executive summary:
On the basis of an experimental study, the LD50 for the oral route of the mephtamin (CAS : 139525-77-2) is 1205 mg/kgbw (wistar rat).
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