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Toxicological information

Acute Toxicity: oral

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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:
2009
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

Constituent 1
Reference substance name:
COASOL
IUPAC Name:
COASOL
Constituent 2
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
Constituent 3
Chemical structure
Reference substance name:
Reaction mass of diisobutyl adipate and diisobutyl glutarate and diisobutyl succinate
EC Number:
907-870-9
Molecular formula:
Diisobutyl succinate: C12O4H22 Diisobutyl glutarate: C13O4H24 Diisobutyl adipate: C14O4H26
IUPAC Name:
Reaction mass of diisobutyl adipate and diisobutyl glutarate and diisobutyl succinate
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

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:
There were no clinical signs of toxicity
Body weight:
no effects on bodyweight gain
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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