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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:
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:
1988
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
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

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals 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:
Transient mild depression and oily hair coats. Both signs disappeared by day 5.
Body weight:
Body weight gain appeared 'normal' but no concurrent controls to reference against.
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