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Toxicological information

Repeated dose toxicity: inhalation

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Administrative data

Endpoint:
short-term repeated dose toxicity: inhalation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
Not reported
Reliability:
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 report following sound scientific principles.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1991
Reference Type:
publication
Title:
Evaluation of the acute and sub acute inhalation toxicity of lubricating oil mists
Author:
Whitman, F. T., Freeman, J. J., Infurna, R. N., Phillips, R. D.
Year:
1989
Bibliographic source:
The Toxicologist 9: 143

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 412 (Subacute Inhalation Toxicity: 28-Day Study)
Principles of method if other than guideline:
The method did not strictly follow the guideline but is deemed appropriate as utilized in this report.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: Oily liquids
Details on test material:
Since PAC are not likely to cause any adverse local effects in lungs after sub-actute exposure, the sufficiently refined lubricant base oils can be used as read-across for this endpoint.


Test Substance: Two refined, solvent-extracted paraffinic mineral base oils The oils spanned a range of 60 - 150 SUS @ 100°F, approximately 12-30 mm2/s).

- Substance Type: Other Lubricant Base Oils (Sufficiently Refined, IP 346 < 3%)

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
not specified
Duration of treatment / exposure:
2 weeks
Frequency of treatment:
6 hours/day
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 50, 500, and 1500 mg/m3
Basis:

Control animals:
other: no data

Results and discussion

Results of examinations

Clinical signs:
not specified
Mortality:
not specified
Body weight and weight changes:
not specified
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
not specified
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified

Effect levels

open allclose all
Dose descriptor:
NOAEC
Remarks:
For pulmonary toxicity
Effect level:
ca. 500 mg/m³ air
Sex:
not specified
Basis for effect level:
other: Pulmonary toxicity including focal infiltrations of inflammatory cells, focal hyperplasia and squamous metaplasia of the nasal mucosa, and accumulations of inflammatory exudates in the lumen of the nasal cavity
Dose descriptor:
NOAEC
Remarks:
For systemic toxicity
Effect level:
>= 1 500 mg/m³ air
Sex:
not specified
Basis for effect level:
other: Based on the lack of systemic toxicity observed at this dose level.

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

There were no mortalities.  Exposure-related changes were noted in  animals from the most highly exposed groups.  These changes, including  focal infiltrations of inflammatory cells, focal hyperplasia and squamous  metaplasia of the nasal mucosa, and accumulations of inflammatory  exudates in the lumen of the nasal cavity, were interpreted as the result  of a mild irritating process in the nasal mucosa.  No other microscopic  changes were observed in any other tissues that indicated systemic  toxicity from exposure to the refined lubricant base oils.  The NOAEL for  pulmonary effects was 500 mg/m3, and the NOAEL for systemic effects was  >1500 mg/m3.

Applicant's summary and conclusion

Conclusions:
The NOAEC for pulmonary effects was 500 mg/m3, and the NOAEC for systemic effects was ≥1500 mg/m3.
Executive summary:

Justification for Read Across

Since PAC are not likely to cause any adverse local effects in lungs after sub-actute exposure, sufficiently well-refined lubricant base oils can be sued as read-across for this endpoint.

Two solvent-extracted paraffinic mineral base oils were evaluated in 2-week inhalation toxicity studies (Whitmanet al., 1989; EBSI, 1991 a,b).The oils spanned a range of 60 – 150 SUS @ 40oC, approximately 12-30 mm2/s). Rats were exposed 6 hours/day to aerosol concentrations of approximately 0, 50, 500, and 1500 mg/m3. There were no mortalities but exposure-related changes were noted in animals from the most highly exposed groups. These changes, including focal infiltrations of inflammatory cells, focal hyperplasia and squamous metaplasia of the nasal mucosa, and accumulations of inflammatory exudates in the lumen of the nasal cavity, were interpreted as the result of a mild irritating process in the nasal mucosa. No other microscopic changes were observed in any other tissues that indicated systemic toxicity from exposure to the lubricant base oils. The NOAEC for pulmonary effects was 500 mg/m3, and the NOAEC for systemic effects resulting from inhalation exposure was 1500 mg/m3. 

This study is classified as reliable with restrictions because it is an acceptable, well-documented study report following sound scientific principles.