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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:
weight of evidence
Study period:
1981-07-31 to 1981-08-28
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable without restrictions because it generally adhered to OECD 403 guidelines and was GLP compliant.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
Data on the chemical and chamber humidity and temperature were not reported.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): SF-0203-41
- Substance type: 1-Decene dimer hydrogenated
- Physical state: Liquid
- Analytical purity: >99%
- Lot/batch No.: Not reported
- Stability under test conditions: Stated to be stable
- Storage condition of test material: Not reported

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratory, Portage, Michigan
- Age at study initiation: It varied from 47 to 67 days of age
- Weight at study initiation: Males: 201 to 295 grams; females: 149 to 214 grams
- Housing: Individually during and post exposure
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Not reported

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light

IN-LIFE DATES: From: 1981-07-31 To: 1981-08-28

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: FMI Lab Pump
- Exposure chamber volume: 54 litres
- Method of holding animals in test chamber: Individual cages in chamber
- Source and rate of air: HVAC system separate from the general laboratory system at a flow rate of 40 litres per minute
- Method of conditioning air: Air was filtered for particulates and controlled for temperature and humidity
- System of generating particulates/aerosols: The pump moved the test material at a constant rate to the spraying Systems atomizer equipped with a number 1650 liquid nozzle and a number 64 air nozzle and operated by compressed in house air.
- Method of particle size determination: Using an Anderson 8 stage cascade impactor
- Treatment of exhaust air: Filtered and discharged into the chamber exhaust system
- Temperature, humidity, pressure in air chamber: Not reported

TEST ATMOSPHERE
- Brief description of analytical method used: The nominal dose was determined by weighing the test material in the reservoir before and after the exposure. The actual exposure measured both particulate and vapour phases by drawing exposure atmosphere through pre-weighed glass fibre filters. Particulate phase was measured by standard gravimetric techniques. The vapour phase was measure using a Scott Total Hydrocarbon Analyzer.
- Samples taken from breathing zone: No

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: 2.7 to 3.2 microns
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 2.9/2.07


Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
0.77, 0.94, 1.1, 1.4, or 5.1 mg/L
No. of animals per sex per dose:
Five
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed once daily and weighed on day 7 and 14
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs, body weight, histopathology
Statistics:
No statistical methods were mentioned.

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LC50
Effect level:
1.17 mg/L air
95% CL:
0.94 - 1.46
Remarks on result:
other: Equivalent to 1170 mg/m3
Sex:
female
Dose descriptor:
LC50
Effect level:
0.9 mg/L air
Exp. duration:
4 h
Remarks on result:
other: The LC50 was estimated to be between 0.9 and 1.4 mg/L.
Sex:
male
Dose descriptor:
LC50
Effect level:
1.4 mg/L air
Exp. duration:
4 h
Remarks on result:
other: The LC50 was estimated to be between 1.4 and 2.0 mg/L.
Mortality:
All animals treated with 5.1 mg/L died within 2 days. Two to 5 females from all treatment groups died. No males in the lowest two groups died, but 2 males from each of the other groups died.
Clinical signs:
Clinical signs included dyspnoea and nasal discharge.
Body weight:
Body weight gain was reduced in the first week, but was normal in the second week.
Gross pathology:
Gross necropsy indicates treatment-related effects on the lung occurred only in the animals that died.
Other findings:
- Histopathology: Microscopic lesions in the lung were observed in all 5.1 mg/L animal (only group examined).
- Potential target organs: Lungs

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category II
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on these results, no specific LC50 could be determined, but was estimated to be between 1.4 and 2.0 mg/L in males and 0.9 and 1.4 mg/L in females.
Executive summary:

In an acute inhalation toxicity study, five male and five female Sprague Dawley rats were treated with 0.77, 0.94, 1.1, 1.4, or 5.1 mg/L of aerosol:vapour from SF-0203-41 for 4 hours. All animals treated with 5.1 mg/L died within 2 days. Two to 5 females from all treatment groups died. No males in the lowest two groups died, but 2 males from each of the other groups died. Clinical signs included dyspnoea and nasal discharge. Body weight gain was reduced in the first week, but was normal in the second week. Gross necropsy indicates treatment-related effects on the lung occurred only in the animals that died. Microscopic lesions in the lung were observed in all 5.1 mg/L animal (only group examined). Based on these results, no specific LC50 could be determined, but was estimated to be between 1.4 and 2.0 mg/L in males and 0.9 and 1.4 mg/L in females. The combined LC50 was 1.17 mg/L with a confidence interval of 0.94 to 1.46 mg/L.

This study recieved a Klimisch score of 1 and is classified as reliable without restrictions because it generally adhered to OECD 403 guidelines and was GLP compliant.