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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12 March 1987 to 26 May 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
Using the available equipment it was not possible to generate an atmosphere with a concentration of greater than 935 ug/m3
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
heptan-2-yl [(5-chloroquinolin-8-yl)oxy]acetate
EC Number:
619-447-3
Cas Number:
99607-70-2
Molecular formula:
C18H22ClNO3
IUPAC Name:
heptan-2-yl [(5-chloroquinolin-8-yl)oxy]acetate
Details on test material:
- Name of test material (as cited in study report): CGA185072 technical
- Physical state: solid, powder
- Analytical purity: 91.6%
- Expiration date of the lot/batch: Not specified

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 6-8 weeks
- Weight at study initiation: circa 200 g
- Fasting period before study: None specified
- Housing: Conventional laboratory cages
- Diet (e.g. ad libitum): not specified
- Water (e.g. ad libitum): Not specified
- Acclimation period: 5 days

IN-LIFE DATES: From: 12.03.1987 To: 26.05.1987

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
nose only
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: aerosol generated using Wright dust generator
- Exposure chamber volume: not specified
- Method of holding animals in test chamber: nose-only exposure restraint tubes
- Source and rate of air: flow rate for air supply was 25 L/min
- Method of conditioning air: not specified
- System of generating particulates/aerosols: Wright dust generator
- Method of particle size determination: two samples taken duriing exposure using Cascade impactor
- Treatment of exhaust air: not specified
- Temperature, humidity, pressure in air chamber: temperature - 22.0 +/- 0.1C; Humidity 42+/-2% RH

TEST ATMOSPHERE
- Samples taken from breathing zone: yes

VEHICLE
- Composition of vehicle (if applicable): air
- Concentration of test material in vehicle (if applicable): Nominal concentration = 935 mg/m3 and gravimetrically determined concentration = 935+/-482 mg/m3

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: see tabulated results



Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
ca. 4 h
Concentrations:
The maximum possible concentration that could be achieved for this test material under the conditions of the test was 935 mg/m3. From gravimetric analysis it was determined that in excess of 70% of the dust generated was respirable.
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observed twice daily for 14 days. Bodyweights recorded pre-test and at weekly intervals subsequently
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, food consumption
Statistics:
No statistical analysis as the median lethal dose concentration exceeded the maximum atmosphere concentration that could be generated.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 935 mg/m³ air
Based on:
other: nominal concentration
Exp. duration:
4 h
Remarks on result:
other: One male only (of five males and five females) died.
Mortality:
One male died immediately after removal from the exposure chamber
Clinical signs:
other: Dyspnoea, lethargy and brown stains around the snout were observed in most treated animals
Body weight:
All animals gained weight during the study
Gross pathology:
The stomach of the rat which died was distended with gas. There were no other macroscopic abnormalities observed
Other findings:
None

Any other information on results incl. tables

Dose

Mortality

Control group

935 mg/m3

0 / 5

1 / 5

Control group

935 mg/m3

0 / 5

0 / 5

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The inhalation LC50 in rats was greater than 935 mg/m3 (the maximum practical atmosphere concentration that could be generated).
Executive summary:

CGA185072 technical, purity 91.6%, batch P. 607001/002, was administered by inhalation exposure to Wistar rats 6 -8 weeks old at study initiation. There were 5 males and 5 females in the treated group and a further group of controls. An atmosphere was generated by a Wright dust generator, which scraped the test material from the surface of a compressed powder in a stream of air (flow rate 25 l/min). The maximum concentration which could be generated was 935 mg/m3. The animals were exposed for 4 hours in a nose-only chamber. Animals were observed twice daily for 14 days. Body weights and food consumption were recorded pretest and weekly thereafter. After 14 days surviving animals were sacrificed and subjected to gross necropsy. Lung weights were recorded. One male died immediately following completion of the exposure period. The remaining nine rats survived. Clinical observations included dyspnoea, lethargy and brown stains around the snout. All rats gained weight and no necropsy abnormalities were seen. The inhalation LC50 was greater than 935 mg/m3.

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