1-Decene, tetramer, mixed with 1-decene trimer, hydrogenated

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

1988-03-04 to 1988-03-21

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study is classified ‘reliable without restriction’ because it followed GLP standards, and followed guideline recommendations current at the time of execution.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report Date:

1988

Materials and methods

Test guideline

Qualifier:

according to

Guideline:

other: 16 CFR 1500

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Name of test material (as cited in study report): Emery 3002
- Substance type: Poly alpha olefin (1-decene dimer, hydrogenated)
- Physical state: Clear liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Zivic-Miller Labs, Inc.
- Age at study initiation: Not provided
- Weight at study initiation: 178 to 250 grams
- Fasting period before study: Overnight prior to dosing
- Housing: Housed in groups of five in stainless steel wire mesh suspension cages
- Diet (e.g. ad libitum): Purina Laboratory Chow; ad libitum
- Water (e.g. ad libitum): Tap water; ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not provided
- Humidity (%): Not provided
- Air changes (per hr): Not provided
- Photoperiod (hrs dark / hrs light): 12 hours dark/ 12 hours light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

5000 mg/kg

No. of animals per sex per dose:

5/sex/dose

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observed several times on day of dosing and every day following that until study termination; animals were weighed on day of dosing and on day 14 before sacrifice
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs, body weight, and histopathology

Statistics:

Information regarding statistical analysis, if performed, in not provided in the study report.

Results and discussion

Preliminary study:

None of the treated animals died as a result of exposure to Emery 3002. Treated animals exhibited mild depression and oily and/or scruffy hair coats until day 3 or 4 of the post-dosing observation period. Gross necropsy did not reveal any significant treatment-related findings.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 other: mg/kg

Mortality:

None

Clinical signs:

Treated animals exhibited mild depression and oily and/or scruffy hair coats until day 3 or 4 of the post-dosing observation period.

Body weight:

No body weight changes were reported.

Gross pathology:

No gross pathological changes were noted.

Any other information on results incl. tables

There was no mortality observed in either male or female Sprague-Dawley rats at the limit dose tested. Animals exhibited mild depression and oily and/or scruffy hair coats until day 3 or 4 of the post-dosing observation period. Gross necropsy did not reveal any significant treatment-related findings. 

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information LD50 > 5000 mg/kg Criteria used for interpretation of results: EU

Conclusions:

Emery 3002 is not toxic to Sprague-Dawley rats when administered orally.

Executive summary:

In an acute oral toxicity study Emery 3002 was administered neat, at a dose of 5000 mg/kg to a group of five male and five female Sprague-Dawley albino rats. Following dosing, the animals were observed for gross signs of systemic toxicity and mortality several times a day on the day of dosing, and at least once daily until study termination on day 14. All rats were sacrificed at the end of the study and received a gross necropsy.

 

There was no mortality observed in either male or female Sprague-Dawley rats at the limit dose tested. Animals exhibited mild depression and oily and/or scruffy hair coats until day 3 or 4 of the post-dosing observation period. Gross necropsy did not reveal any significant treatment-related findings. Based on these results, Emery 3002 is classified as not toxic to Sprague-Dawley rats via oral administration.

This study received a Klimisch score of 1 and is classified “reliable without restriction” because it followed GLP standards, and followed guideline recommendations current at the time of execution.