Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: inhalation
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
Cross-reference
Reason / purpose:
reference to same study

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 38-39

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Groups of 5 male and 5 female rats were exposed to oil mists
generated from two highly refined oils. Exposures were by
inhalation six hours each day for a total of 10 days
The two oils were examined in separate experiments.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
not specified
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
14 days
Frequency of treatment:
Six hours per day
Doses / concentrations
Remarks:
Doses / Concentrations:
Controls: Air only Oil 1: 55, 507 and 1507 mg/m3 Oil 2: 50, 513 and 1480 mg/m3
Basis:
nominal conc.
No. of animals per sex per dose:
5
Control animals:
yes

Results and discussion

Effect levels

Dose descriptor:
NOAEL
Effect level:
> 50 mg/m³ air
Based on:
not specified
Sex:
male/female

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

Oil 1

All treated animals survived to study termination. The fur of all animals was saturated with test material and the amount of material present was clearly related to the exposure concentration. Alopecia and scabs subsequently formed in the highest 2 dose groups. Animals in the highest dose group were relatively unresponsive to auditory stimulation. Decreased body weight associated with a decrease in food consumption was recorded for the high dose animals. Biologically significant increases in relative lung and liver weights were observed in he males and females in the high dose group but only in the mid dose females. An increase in white cell counts and the percentage of neutrophils and a decrease in the percentage lymphocytes was observed in the high dose groups only. There were no treatment related histopathological changes in the lowest 2 dose groups. Animals in the highest dose group exhibited the same changes as those observed in the nasoturbinates and lungs of animals exposed to oil 2.

Oil 2

Clinical observations were the same as for those animals exposed to Oil 1, except that there was no scabbing and no treatment related alterations in food consumption. There was a biologically significant increase in absolute and relative lung weights in males and females at the high dose and in females only at the mid dose. Apart from elevated liver alanine and aspartate transaminase levels in the high dose females there were no other treatment related effects. Histological effects considered to be treatment related consisted of an increase in the amount of perivascular and peribronchial lymphoid proliferations and an increase in mixed inflammatory cell infiltrations in the terminal bronchioles and alveolar ducts of the highest two dose groups. Increases in the appearance of focal hyperplasia and squamous cell metaplasia of the anterior nasal mucosa associated with inflammatory cell infiltration were observed in the two highest dose groups. These changes were indicative of mild irritation of the nasal mucosa.

Applicant's summary and conclusion