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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable without restriction because it adhered to the principles outlined in OECD Guideline 423 and was GLP compliant.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Emery 3004
- Substance type: Poly alpha olefin (1-decene trimer and tetramer, hydrogenated)
- Physical state: Liquid
- Analytical purity: Not reported
- Lot/batch No.: #8BU28
- Stability under test conditions: Not reported
- Storage condition of test material: Room temperature
- Other: 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 reported
- Weight at study initiation: 217-281 grams
- Fasting period before study: Overnight prior to dosing
- Housing: Groups of five rats housed in stainless steel wire mesh suspension cages
- Diet (e.g. ad libitum): Purina Laboratory Chow ad libitum except during fasting
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4 days


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


IN-LIFE DATES: From: 1988-03-08 To: 1988-03-22

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 5.0 g/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Not reported
Doses:
5.0 g/Kg
No. of animals per sex per dose:
5/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical Observations - several times on day of dosing and once daily thereafter till day 14; Body weight - Day 0 and Day 14
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs, body weight
Statistics:
No statistical analyses was conducted.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Remarks on result:
other: Based on lack of mortality
Mortality:
No mortality was observed in either male or female rats.
Clinical signs:
Clinical changes noted included mild transitory depression and oily and/or scruffy hair coats, which disappeared by the third day in females and the fourth day in males.
Body weight:
No significant decreases in body weight were observed in male or female rats.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information LD50 >5000 mg/kg body weight Criteria used for interpretation of results: EU
Conclusions:
Based on the lack of clinical toxicity and mortality observed during the study, the acute oral LD50 is >5000 mg/kg.
Executive summary:

In an acute oral toxicity study, 1 group of five fasted Sprague-Dawley albino rats/sex were given a single oral dose of Emery 3004 (undiluted) at a dose of 5000 mg/kg bw and observed for 14 days. 

 

No deaths occurred during the observation period. Clinical changes noted included mild transitory depression and oily and/or scruffy hair coats, which disappeared by the third day in females and the fourth day in males. Necropsies revealed a small spleen and thickened stomach lining in one rat. No other treatment related clinical signs, necropsy findings or changes in body weight were observed. Based on the lack of clinical findings, the acute oral LD50 was determined to be >5000 mg/kg bw for male and female rats.