Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable without restriction because it is similar to OECD Test Guideline 403.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
RAEs are not expected to be more hazardous than DAE; therefore, read across to DAEs represents a conservative approach.

- Name of test material (as cited in study report): F-30-02
- Physical state: liquid, dark brown
- Analytical purity: 100% = hydrocarbons
- Lot/batch No.: 31344 (4/21)
- Expiration date of the lot/batch: April, 1988
- Storage condition of test material: room temperature out of direct sunlight
- Density 0.9466 g/ml
- Approx Flash Point °F 395

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Constant, Quebec
- Age at study initiation: 7 weeks
- Weight at study initiation: 200 to 225 grams (males), 175 to 200 grams (females
- Fasting period before study: no
- Housing: individually housed in stainless steel, wire meshed bottom cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24.4
- Humidity (%): 40 to 60 relative humidity
- Photoperiod (hrs dark / hrs light): 12/12


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: whole body chamber
- Method of holding animals in test chamber: not reported
- Source and rate of air: Rate of air flow through the chamber shall be maintained to insure an exposure environment of at least 19% oxygen
- Airflow through the chamber was set at 45 L/min

TEST ATMOSPHERE
- Brief description of analytical method used: Actual concentrations of airborne test article and particle size distribution measurements shall be measured near the breathing zone at one hour intervals during the exposure period
- Samples taken from breathing zone: yes, hourly

Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
5.0 mg/L
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were observed prior to exposure, hourly during exposure, hourly for the 4-hour exposure and twice daily during the 14-day recovery period
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ preservation
Statistics:
Median lethal dose values shall be calculated for each sex by an accepted method, such as Finnay (1971) Probit Analysis or Litchfield and Wilcoxon (1949). A 95% confidence interval for the median lethal dose should be calculated. Where possible, body weights should be analysed using appropriate techniques such as those described in Snedecor and Cochran (1967).

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5 mg/L air (nominal)
Remarks on result:
other: in terms of gravimetric concentration
Mortality:
No deaths
Clinical signs:
other: All animals were lethargic during the last 2 hours of exposure. From hour 2 of treatment until the first hour post-exposure, animals kept their eyes partially closed and were lacrimating. One rat displayed red nasal discharge following exposure and red
Body weight:
All animals gained weight during the post-exposure observation period
Gross pathology:
Three rats of each sex showed pallor and/or swelling of the kidneys. These findings may be related to treatment.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute inhalation LC50 (aerosol) of distillate aromatic extract is greater than 5.0 mg/L of air. The test material is not classified according to EU criteria.
Executive summary:

Justification for Read Across

For purposes of classification and labelling and registration under REACH, aromatic extracts are sub-divided into the categories of distillate aromatic extracts (DAE), treated distillate aromatic extracts (TDAE), and residual aromatic extracts (RAE). Some of the classifications are based on 3-7 ring PAC content, which is not substantively affected by whether the aromatic extract is derived from paraffinic or naphthenic or “light” or “heavy” crude. Therefore, DAEs and RAEs are not subclassified based on crude oil source or viscosity. For most health endpoints, data from any one of the DAEs can be “read-across” to the remaining DAEs and whole RAE category. 

In an acute inhalation toxicity study, groups of young adult Sprague Dawley rats (5/sex) were exposed by inhalation route to distillate aromatic extract for 4 hours to whole body at a concentrations of 5.0 mg/L. Animals then were observed for 14 days.

All animals were lethargic during the last 2 hours of exposure. From hour 2 of treatment until the first hour post-exposure, animals kept their eyes partially closed and were lacrimating. One rat displayed red nasal discharge following exposure and red ocular discharge. Another rat exhibited yellow eye discharge during the fourth hour post-exposure and red eye discharge the morning following discharge until the end of the third day post-treatment. These findings are considered related to treatment. Three rats of each sex showed pallor and/or swelling of the kidneys. These findings may be related to treatment. The acute aerosol LC50 of distillate aromatic extract is greater than 5.0 mg/L of air. 

 

This study received a Klimisch score of 1 and is classified as reliable without restriction because it is similar to OECD Test Guideline 403.