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Toxicological information

Acute Toxicity: oral

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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.