Registration Dossier

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: summary study report

Data source

Reference
Reference Type:
review article or handbook
Title:
ROBUST SUMMARY OF INFORMATION ON LUBRICATING OIL BASESTOCKS
Author:
American Petroleum Institute
Year:
2003
Bibliographic source:
ROBUST SUMMARY OF INFORMATION ON LUBRICATING OIL BASESTOCKS pag 24-25

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: API method
Deviations:
not specified
Principles of method if other than guideline:
A single dose of undiluted test material (5g/kg) was administered orally to 5 male and 5 female fasted rats. Food and water was made available ad-lib immediately after dosing. The animals were observed for clinical signs and mortality at hourly intervals for the first 6 hours post dosing and
twice daily thereafter. Body weights were recorded prior to fasting, prior to dosing and at 7 and 14 days post dosing. At 14 days, all surviving animals were killed and subjected to a gross necropsy examination.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: administered undiluted
Doses:
5g/kg
No. of animals per sex per dose:
5
Control animals:
not specified

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
not specified

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