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EC number: 700-184-9 | CAS number: 1000172-11-1
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline GLP study for which the full report is available. No concurrent control used
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: US Federal Hazardous Substance Act 16 CFR1500
- Deviations:
- no
- Principles of method if other than guideline:
- Test substance administered as a single dose to rats with observations for a subsequent 14 day period. Post sacrifice, animals weighed and subject to gross necropsy.
- GLP compliance:
- yes
- Remarks:
- US regulation 21CFR 28
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- dec-1-ene. (This relates to the monomer unit.)
- Cas Number:
- 68037-01-4
- IUPAC Name:
- dec-1-ene. (This relates to the monomer unit.)
- Reference substance name:
- 1-decene, homopolymer, hydrogenated
- IUPAC Name:
- 1-decene, homopolymer, hydrogenated
- Reference substance name:
- Dec-1-ene, homopolymer, hydrogenated Dec-1-ene, oligomers, hydrogenated
- EC Number:
- 500-183-1
- EC Name:
- Dec-1-ene, homopolymer, hydrogenated Dec-1-ene, oligomers, hydrogenated
- IUPAC Name:
- 500-183-1
- Details on test material:
- - Name of test material (as cited in study report): Emery 3006
- Molecular formula (if other than submission substance): C10 polyalphaolefin (trimer to hexamer oligomer mixture; C30-60.H62-122)
- Molecular weight (if other than submission substance): 552 (weight average), 528 (number average)
- Smiles notation (if other than submission substance): (CCCCCCCCCC) x 3.8 average
- Substance type: hydrogenated polyalphaolefin oligomer
- Lot/batch No.: 8BU27
- Physical state: clear liquid
- Storage condition of test material: room temperature in a metal container with lid
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Zivic-Miller labs inc
- Weight at study initiation: 231-282g
- Fasting period before study:
- Housing: groups of five per sex in mesh suspension cages
- Diet (e.g. ad libitum): Purina lab chow ad libitum except for overnight prior to dosing.
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: four days.
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12 hour
IN-LIFE DATES: From: 9/3/88 for 14 days
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE - none
MAXIMUM DOSE VOLUME APPLIED: 5g/kg - Doses:
- 5g/kg
- No. of animals per sex per dose:
- 5 per sex
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: (14 days),
- Frequency of observations: several times on day 0 and daily thereafter. Body weight only at start and termination of study.
- Gross necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology - Statistics:
- not relevant based on results
Results and discussion
- Preliminary study:
- no preliminary study
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- None
- Clinical signs:
- other: Transient mild depression and oily hair coats. Both signs disappeared by day 5.
- Gross pathology:
- Yellow brown spot on the stomach lining of a single animal (sex not specified). Biological relevance unclear.
- Other findings:
- no other findings reported.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Practically non-toxic
- Executive summary:
In a GLP acute toxicity limit study to a US protocol, a similar substance (a hydrogenated decene oligomer of weight average molecular weight 552) was found to have an LD50 greater than the maximum dose tested (5g/kg.) There was no evidence of other significant non-lethal toxic effects occurring. It was not possible to assess if there was any adverse impact on body weight gain as no concurrent control was used.
Synopsis:
LD50 > 5000mg/kg
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