Registration Dossier
Registration Dossier
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EC number: 298-364-0 | CAS number: 93803-89-5
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
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Only summary of the results given
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- limited reporting, only 8 days obeservation
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Isononanoic acid, mixed esters with dipentaerythritol, heptanoic acid and pentaerythritol
- EC Number:
- 282-775-7
- EC Name:
- Isononanoic acid, mixed esters with dipentaerythritol, heptanoic acid and pentaerythritol
- Cas Number:
- 84418-63-3
- IUPAC Name:
- 84418-63-3
- Details on test material:
- - Name of test material (as cited in study report): Only trade name given
- Analytical purity: no data
- Lot/batch No.: Bx160491
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: ALpk:AP
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: ICI Pharmaceuticlas, Alderley Park, Cheshire, UK
- Age at study initiation: approx. 6-10 weeks
- Weight at study initiation: 239 - 250 g (males); 184 - 202 g (females)
- Fasting period before study: 24 h
- Diet: ad libitum
- Water: ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg bw
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- other: not required
- Details on study design:
- - Duration of observation period following administration: 8 days
- Frequency of observations and weighing: prior to fasting, immediately prior dosing and at the end of the study
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None of the animals died during the observation period of 8 days.
- Clinical signs:
- other: No significant signs of toxicity were observed.
- Gross pathology:
- There were a small number of gross abnormalities at post mortem (not further specified). These were part of a spectrum of known background changes seen in this rat strain and considered not to be treatment related.
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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