Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1984-09-25 to 1984-10-09
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable without restriction because it was carried out according to or similar to OECD Guideline 401.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
GLP compliance:
yes
Test type:
fixed dose procedure

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Read Across to Lubricant Base Oils
- Test substance: API 83-12 (CAS No. 64742-53-6)
- Name of test material (as cited in study report): API 83-12
- Substance Type: Lubricant Base Oils (IP 346 ≥ 3%)
- Molecular weight (if other than submission substance): 148.3
- Physical state: clear, colorless liquid
- Composition of test material, percentage of components: 61.6% saturates, 36.1% aromatics, 2.3% polar compounds
- Viscosity: 53.5 SSU at 100°F, 33.3 SSU at 210°F
- Sulphur, Wt%: 0.019
- Gravity API: 26.2
- Flash Point 255°F
- Distillation at 10% 533, at 95% 713 °F
- Initial Boiling Point: 464°F
- End Point 796 °F
- Pour Point 60°F
- Colour 0.5
- Aniline 148.3 °F

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Stone Ridge, New York
- Age at study initiation: approximately 7 weeks
- Weight at study initiation: between 295 and 349 grams for males; between 231 and 248 grams for females
- Fasting period before study: overnight prior to testing
- Housing: group cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24°C
- Humidity (%): 54% to 64% relative humidity
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark


IN-LIFE DATES: From: 1984-09-25 To: 1984-10-09

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 5.62 ml/kg bw based upon average bulk density of 0.89 g/mL
Doses:
5000 mg/kg fasted body weight
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observed for clinical signs and mortality at hourly intervals for 6 hours after test article administration; observed twice daily thereafter for 14 days for clinical signs and mortality; body weights were taken before fasting, just prior to test material administration, and at 7 and 14 days following administration of test material
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, gross necropsy examination
Statistics:
No statistics were performed in the study.

Results and discussion

Preliminary study:
Not applicable.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No mortality was observed.
Clinical signs:
Clinical signs seen during the study included hypoactivity, yellow-stained anal area, hair loss in urogenital region, and swollen hind paws. All animals had returned to normal by day 3 with the following exceptions: one male rat and two female rats exhibited hair loss in the urogenital region on days 6 and 7. This abnormality continued in one male and female rat through day 10. One female rat exhibitedhypoactivity on days 6 and 7. One female rat
exhibited swollen hind paws on day 7,and from day 10 through study termination.
Body weight:
No data reported.
Gross pathology:
One female had a spleen that was cystic, mottled red and tan, and rough surface. The animal's pancreas adhered to the entire surface of the spleen. All other animals had no visible lesions upon gross examination.
Other findings:
No data reported.

Any other information on results incl. tables

There were no deaths during the study.
Clinical signs observed included: hypoactivity, yellow-stained anal area,
  hair loss in the urogenital region and swollen hind paws.
All animals returned to normal by day 3 and had gained weight by day 7.
At necropsy, there were no visible lesions except in one female in which
 the spleen was cystic, mottled red and tan and had a rough surface. In  this animal the pancreas adhered to the entire surface of the spleen.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 for rats is greater than 5000 mg/kg bw when administered by gavage.
Executive summary:

Read across justification

The physical and chemical properties of foots oils are comparable to the other lubricant base oil intermediate streams from which they are derived. Hence their health effects are also similar to those of other lubricant base oils, and the conclusions of the hazard assessment for other lubricant base oils also apply to foots oils.

In an acute oral toxicity study, Sprague-Dawley rats (5/sex) were administered a single oral gavage of API 83-12 at a dose level of 5000 mg/kg and observed for 14 days. No mortalities were observed and clinical signs included hypoactivity, yellow-stained anal area, hair loss in the urogenital region and swollen hind paws. All animals returned to normal by day 3 and gained weight by day 7. At gross necropsy, one female animal had aspleen which was cystic, mottled red and tan and had a rough surface. In this animal, the pancreas adhered to the entire surface of the spleen. All other animals were free of visible lesions. The oral LD50 was determined to be greater than 5000 mg/kg in both males and females.

This study received a Klimisch score of 1 and is classified as reliable without restriction because it was carried out in accordance with OECD Guideline 401.