Registration Dossier
Registration Dossier
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EC number: 290-580-3 | CAS number: 90193-76-3
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 19 Nov - 02 Dec 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP - guideline study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- The temperature should be 22 ± 3 °C. Nevertheless, the temperature was 24.0 - 25.5 °C.
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Di(tridecyl) phthalate
- EC Number:
- 204-294-3
- EC Name:
- Di(tridecyl) phthalate
- Cas Number:
- 119-06-2
- Molecular formula:
- C34H58O4
- IUPAC Name:
- ditridecyl phthalate
- Details on test material:
- - Name of test material (as cited in study report): Ditridecyl phthalate
- Physical state: colorless clear liquid
- Analytical purity: 93.7 - 100%
- Lot/batch No.: 2700
- Storage condition of test material: At room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories Japan, Inc., Yokohama, Japan
- Age at study initiation: 6 weeks
- Weight at study initiation: male: 125.8 g (121.4 -129.6 g); female: 114.1 g (109.1 - 118.2 g)
- Fasting period before study: 18 hours before study
- Housing: stainless steel cage
- Diet (ad libitum): CRF-1 from Oriental Yeast Co., Ltd.
- Water (ad libitum): tap water
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 - 25.5 °C
- Humidity (%): 51 - 64
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Lot/batch no. (if required): V6N3521
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred in all groups during study conducted.
- Clinical signs:
- other: Soft feces were observed in control groups of both sexes after 1 to 6 hours of administration. But no other clinical signs were evident in male and female rats.
- Gross pathology:
- No effect on gross pathology was found in males and females.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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