Registration Dossier
Registration Dossier
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EC number: 271-237-7 | CAS number: 68526-89-6 A complex combination of hydrocarbons produced by the distillation of products from the hydrogenation of isononanal from the hydroformylation of octene. It consists predominantly of C9-10 primary aliphatic alcohols, C10-20 dimer alcohols, C>18 acetals and esters and C>18 acid sodium salts and boils in the range of approximately 200°C to 400°C (392°F to 752°F).
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
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)
- Remarks:
- Safepharm Laboratories Limited, Shardlow, Derbyshire, UK
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Octene, hydroformylation products, high-boiling
- EC Number:
- 271-237-7
- EC Name:
- Octene, hydroformylation products, high-boiling
- Cas Number:
- 68526-89-6
- Molecular formula:
- Unspecified
- IUPAC Name:
- Reaction products of octene, hydroformylation products of C8-alkenes, high boiling
- Details on test material:
- - Name of test material (as cited in study report): Oxooil HS9
- Physical state: pale yellow liquid
- Analytical purity: not stated
- Storage condition of test material: room temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Limited, Bicester, Oxon, UK
- Age at study initiation: eight to twelve weeks of age
- Weight at study initiation: mean: 174 g
- Fasting period before study: overnight
- Housing: in groups of up to four
- Diet: free access to Certified Rat and Mouse Diet (with the exception of an overnight fast immediately before dosing and for approximately three to four hours after dosing)
- Water: free access to drinking water (with the exception of an overnight fast immediately before dosing and for approximately three to four hours after dosing)
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Air changes (per hr): at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 2.38 ml/kg
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 female animals
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical observations were made 0.5, 1, 2, and 4 hours after dosing and subsequently once daily for up to fourteen days. Morbidity and mortality checks were made twice daily. Individual bodyweights were recorded on Day 0 (the day of dosing) and on Days 7 and 14.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths.
- Clinical signs:
- other: There were no signs of systemic toxicity.
- Gross pathology:
- No abnormalities were noted at necropsy.
Applicant's summary and conclusion
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