White mineral oil (petroleum)

Acute Toxicity: inhalation

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

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

8042-47-5

Cas Number:

8042-47-5

IUPAC Name:

8042-47-5

Constituent 2

Reference substance name:

Highly refined base oil

IUPAC Name:

Highly refined base oil

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 or test system 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:

other: 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.