Registration Dossier
Registration Dossier
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EC number: 907-870-9 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- COASOL
- IUPAC Name:
- COASOL
- Reference substance name:
- Reaction mass of bis(2-methylpropyl) pentanedioate and bis(2-methylpropyl) butanedioate and bis(2-methylpropyl) hexanedioate
- IUPAC Name:
- Reaction mass of bis(2-methylpropyl) pentanedioate and bis(2-methylpropyl) butanedioate and bis(2-methylpropyl) hexanedioate
- Reference substance name:
- 1,4-bis(2-methylpropyl) butanedioate; 1,5-bis(2-methylpropyl) pentanedioate; 1,6-bis(2-methylpropyl) hexanedioate
- EC Number:
- 907-870-9
- Molecular formula:
- Diisobutyl succinate: C12O4H22 Diisobutyl glutarate: C13O4H24 Diisobutyl adipate: C14O4H26
- IUPAC Name:
- 1,4-bis(2-methylpropyl) butanedioate; 1,5-bis(2-methylpropyl) pentanedioate; 1,6-bis(2-methylpropyl) hexanedioate
- Details on test material:
- - Name of test material (as cited in study report): COASOL
- Physical state: Liquid
- Analytical purity: 100%
- Composition of test material, percentage of components: 22.9 %(w/w) Diisobutyl succinate; 56.4% (w/w) Diisobutyl glutarate; 19.1% (w/w) Diisobutyl adipate
- Purity test date: 07/Aug/2009
- Lot/batch No.: 50046869
- Expiration date of the lot/batch: 05/August/2010
- Stability under test conditions: stable
- Storage condition of test material: room temperature in the dark
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 females. Only females were used as they are typically more sensitive, and are the preferred choice when it is unknown if there is a sex difference in toxicity
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- There were no deaths
- Clinical signs:
- other: There were no clinical signs of toxicity
- Gross pathology:
- No abnormalities identified at necropsy
- Other findings:
- none
Any other information on results incl. tables
There were no deaths. There were no clinical signs of toxicity, no effects on bodyweight gain nor any abnormalities at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- There were no deaths at the limit dose of 2000 mg/kg bw. Therefore this substance does not require classification for acute oral toxicity.
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