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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1985-02-11 to 1985-03-04
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable without restriction because it was conducted similar to OECD guideline 403 and GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: Oily liquid
Details on test material:
- Name of test material (as cited in study report): F-52-01
- Physical state: transparent colorless liquid
- Purity: 100% petroleum hydrocarbons
- Density: 0.8433 g/mL
- Lot/batch No.: 769
- Expiration date of the lot/batch: September 1989
- Storage condition of test material: Temperature-monitored room, out of direct light and away from radiation sources
- Other: Flash point is 355 degrees fahrenheit

Test animals

Species:
rat
Strain:
other: Crl:CD(SD)BR
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Canada, Inc., St. Constant, Quebec, Canada
- Age at study initiation: 8 to 12 weeks old
- Weight at study initiation: 216 to 240 grams
- Fasting period before study: not reported
- Housing: individually housed in stainless steel, wire mesh-bottom cages
- Diet (e.g. ad libitum): ad libitum except during 4-hour exposure period
- Water (e.g. ad libitum): ad libitum except during 4-hour exposure period
- Acclimation period: not reported


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.6 to 22.2°C
- Humidity (%): 33 to 72%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported


IN-LIFE DATES: From: 1985-02-11 To: 1984-03-04

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: 27" cubed stainless steel whole-body exposure chamber
- Exposure chamber volume: 400 litres
- Method of holding animals in test chamber: none
- Source and rate of air: 45 L/min
- Method of conditioning air: not reported
- System of generating particulates/aerosols: Thermo Systems Inc. 6-jet atomizer supplied with pre-dried compressed air
- Method of particle size determination: Andersen 1 ACFM Ambient sampler
- Treatment of exhaust air: passed through HEPA filter and activated charcoal filter before release
- Temperature, humidity, pressure in air chamber: 21.1 celsius average temperature, 63.5% average humidity, pressure not reported


TEST ATMOSPHERE
- Brief description of analytical method used: gravimetric analysis
- Samples taken from breathing zone: yes
- Particle size distribution: not reported
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 2.7 micrometres / 2.2 micrometres
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
5 mg/L
No. of animals per sex per dose:
5 animals per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed prior to exposure, hourly during exposure, hourly for four hours following exposure, and twice daily during the remainder of the 14-day exposure period. Animals were weighed upon receipt at the research facility, on the day of treatment prior to exposure, and on days 7 and 14 of the study.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs were noted

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Mortality:
No mortality was observed during the study period.
Clinical signs:
Clinical signs included labored breathing, rales, partial closing of the eyes, nasal discharge, recumbency, and incoordination. All animals appeared normal at day 5 after exposure and throughout the remainder of the study period.
Body weight:
Four of five females had transient weight loss during the first week of observation.
Gross pathology:
No pathological observations were noted.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LC50 of Highly refined base oil aerosol administered to rats is greater than 5 mg/L. This dose level is not classifiable according to EU guidelines.
Executive summary:

In an acute inhalation study, Highly refined base oil was administered to Crl:CD(SD)BR rats (5/sex) via whole-body exposure at a dose level of 5 mg/L for 4 hours. Animals were observed for 14 days post exposure.

No mortality was observed. Clinical signs included laboured breathing, rales, partial closing of the eyes, nasal discharge, recumbency, and incoordination. All animals appeared normal at day 5 after exposure and throughout the remainder of the study period. Four of five females had transient weight loss during the first week of observation. The LC50 of Highly refined base oil aerosol administered to rats is greater than 5 mg/L. This dose level is not classifiable according to EU guidelines.

This study received a Klimisch score of 1 and is classified as reliable without restriction because it was conducted similar to OECD guideline 403 and GLP.