Registration Dossier

Toxicological information

Acute Toxicity: inhalation

Currently viewing:

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP study, no internationally accepted protocol mentioned but test procedure is described in sufficient detail.

Data source

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

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
A sonic jet nebulizer was used to generate the test material atmosphere. The test material was metered under pressure through a small stainless steel capillary tube (0,030" I.D.) and 3 feet of 1/4" polyethylene tubing to an orifice where an air stream was directed at a right angle to the liquid flow. This orifice is a sonic jet and will produce either an aerosol or an aerosol-vapour mixture, depending upon the test material's vapour pressure.

A single 4-hour exposure was conducted using 5 animals of each sex. Nominal concentrations were determined hourly throughout the exposure and were maintained at approx. 4,15 mg/L of air. Animals were weighed just prior to the exposure, and on post-exposure days 2, 7, and 14. Gross observations for signs of toxicity were recorded during the exposure and twice daily during the 14-day post-exposure period. Gross necropsies were performed on all animals.
GLP compliance:
yes
Test type:
other: not specified
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Acryloid HF-422
- Physical state: liquid
- Composition of test material, percentage of components:
* 70,8% dibutylphenylphosphate
* 29,2% n-butylmethacrylate polymer
- Lot/batch No.: QL-3 (3/7/79)

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 55 days (females), 60-75 days (males, according to protocol)
- Weight at study initiation: 172-220g (females), 200-300g (males, according to protocol)
- Fasting period before study: no data
- Housing: two per cage
- Diet: Purina Standard Laboratory Rodent Chow, ad libitum
- Water: ad libitum
- Acclimation period: according to standard procedures (not copied in study report)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 72 +/- 2°F
- Humidity (%): 35-60%
- Air changes (per hr): see other section
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
other: combination of aerosol and vapour
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: sonic jet nebulizer (Laskin style)
- Exposure chamber volume: 300L
- Source and rate of air: room air, exposure chamber airflow was maintained at 70L/min, i.e. 14 air-changes per hour.
- System of generating particulates/aerosols: test material was metered under pressure through a small stainless steel capillary tube (0,030" I.D.) and 3 feet of 1/4" polyethylene tubing to an orifice where an air stream was directed at a right angle to the liquid flow.

TEST ATMOSPHERE
A nominal concentration will be determined 3 times during the run: at the beginning, after several hours and within 1 hour of termination. The presence of an aerosol in the chamber will be recorded.

VEHICLE
- Composition of vehicle: corn oil
- Concentration of test material in vehicle: 50.9% wt/wt
- Justification of choice of vehicle: use of vehichle was required due to the test material viscosity
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
4 h
Concentrations:
4,15 mg/L
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
* weighing: just prior to exposure + at days 2, 7 and 14
* observation: during the exposure + twice daily afterwards
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC0
Effect level:
4.15 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
4 h
Mortality:
No deaths occurred during the exposure or during the 14-day post exposure period.
Clinical signs:
other: chromodacryorrhea around the nose durint the exposure in all animals.
Body weight:
No treatment effects were noted in the individual or mean body weights during the entire study period.
Other findings:
occasional mottled liver in 2 females

Any other information on results incl. tables

A light aerosol mist was visible during the entire exposure and the calculated mean nominal concentration was 4,15 mg/L of air.

Applicant's summary and conclusion

Conclusions:
The test substance, when administered by inhalation under the experimental conditions described above produced a low acute toxicity in male and female rats.