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Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

acute toxicity: oral
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1984-10-31 to 1987-03-25
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable with restrictions because it is an acceptable, well-documented study that meets basic scientific principles.

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
equivalent or similar to guideline
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
No information on the test guideline followed was available.
GLP compliance:
Test type:
standard acute method

Test material

Constituent 1
Reference substance name:
Cas Number:
Constituent 2
Reference substance name:
Highly refined base oil
Highly refined base oil
Test material form:
other: Oily liquid
Details on test material:
- Name of test material (as cited in study report): F-53-01, ARCOprime 400
- Substance type: white mineral oil
- Physical state: transparent, colorless liquid
- Lot/batch No.: Lot#662
- Expiration date of the lot/batch: September 1989
- Storage condition of test material: Temperature-monitored room between 50 and 80 degrees fahrenheit. Avoid light and radiation sources.
- Density: 0.8682 g/mL
- Flash Point °F: 450

Test animals

Details on test animals or test system and environmental conditions:
- Source: Simonsen Laboratories, Inc., Gilroy, CA
- Age at study initiation: young adults
- Weight at study initiation: 180 to 245 grams
- Fasting period before study: One week prior to testing date, animals were fasted and did not come up to dosing weight. Animals were put back on food for another week. All rats were fasted for a second time at 16 hours prior to dosing.
- Housing: Individually housed in stainless steel, wire mesh bottom cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14 days

- Temperature (°C): between 21.1 and 24.4°C
- Humidity (%): between 28 and 60%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark

IN-LIFE DATES: From: 1984-10-24 To: 1984-11-21

Administration / exposure

Route of administration:
oral: gavage
unchanged (no vehicle)
Details on oral exposure:
Dosage prepared based on weight of animals and density of test material
5000 mg/kg
No. of animals per sex per dose:
5 animals per sex per dose
Control animals:
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed hourly for the first four hours after dosing and twice daily thereafter. Animals were weighed just prior to dosing and at days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
No data reported.

Results and discussion

Effect levels
Dose descriptor:
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
No mortality was observed.
Clinical signs:
other: One of ten rats exhibited loose stools on day of dosing. One of ten rats exhibited ocular swelling on day 6, but this sign was not considered to be treatment-related. All animals did not exhibit any clinical signs from day 7 until end of study period.
Gross pathology:
No gross lesions were observed at necropsy.
Other findings:
One female lost one gram during the first week of study, and one female lost two grams of weight during week two. All rats had an overall net weight gain over the study.

Applicant's summary and conclusion

Interpretation of results:
not classified
Migrated information Criteria used for interpretation of results: EU
The acute oral LD50 of highly refined base oil is greater than 5000 mg/kg. This dosing level is not classifiable according to EU guidelines.
Executive summary:

In an acute oral toxicity study, Sprague-Dawley rats (5/sex) were administered a single oral gavage dose of 5000 mg/kg of Highly refined base oil. Animals were observed for 14 days after dosing.

No mortality was observed. One of ten animals exhibited loose stools on the day of dosing. No gross lesions were present at necropsy. All animals exhibited an overall net weight gain over the study period. The acute oral LD50 of Highly refined base oil is greater than 5000 mg/kg and not classifiable according to EU guidelines.

This study received a Klimisch score of 2 and is classified as reliable with restrictions because it is an acceptable, well-documented study which meets basic scientific principles.