Registration Dossier
Registration Dossier
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EC number: 610-200-5 | CAS number: 446292-07-5
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- Sep to Oct 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well reported GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
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:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 2-[(2R)-2-hydroxy-3-{[4-(3-oxomorpholin-4-yl)phenyl]amino}propyl]-1H-isoindole-1,3(2H)-dione
- EC Number:
- 610-200-5
- Cas Number:
- 446292-07-5
- Molecular formula:
- C21 H21 N3 O5
- IUPAC Name:
- 2-[(2R)-2-hydroxy-3-{[4-(3-oxomorpholin-4-yl)phenyl]amino}propyl]-1H-isoindole-1,3(2H)-dione
- Details on test material:
- Hydroxyaminophthalimid, yellowish powder, Batch BXR3528, content: 98.2%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: tap water with the aid of 2% Cremophor EL
- Doses:
- 2000 mg/kg with an administration volume of 10 ml/kg
- No. of animals per sex per dose:
- 3
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- other: LD50 cut-off
- Effect level:
- 5 000 mg/kg bw
- Based on:
- test mat.
Any other information on results incl. tables
A dose of 2000 mg/kg was tolerated by females without mortalities, toxicological effects on body weight and body weight gain and gross pathological findings. No clinical signs were observed.
| Dose mg/kg | Toxicological result* | Occurence of signs | Time of death | Mortality (%) |
| (1st) 2000 | 0 / 0 / 3 | -- | -- | 0 |
| (2nd) 2000 | 0 / 0 / 3 | -- | -- | 0 |
* Number of animals which died spontaneously and/or were sacrificed in moribund state / Number of animals with signs of toxicity / Total number of animals used per group
Applicant's summary and conclusion
- Executive summary:
The acute oral toxicity to female Wistar rats of Hydroxyaminophthalimid was assessed. The test compound was formulated in tap water with the aid of 2% Cremophor EL, the administration volume was 10 ml/kg body weight.
According to the OECD guideline 423 the LD50 cut-off of Hydroxyaminophthalimid in female rats is >= 5000 mg/kg (Category 5 of the GHS System).
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