Pentadecane, 7-methylene-, mixed with 1-tetradecene, dimers and trimers, hydrogenated

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:

1988

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

Test material information

Constituent 1

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.)

Constituent 2

Reference substance name:

1-decene, homopolymer, hydrogenated

IUPAC Name:

1-decene, homopolymer, hydrogenated

Constituent 3

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

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