Reaction mass of butyl diphenyl phosphate and dibutyl phenyl phosphate and tributyl phosphate

Acute Toxicity: inhalation

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

Test material information

Constituent 1

Reference substance name:

Acryloid HF-422 (DBPP - polymer)

IUPAC Name:

Acryloid HF-422 (DBPP - polymer)

Constituent 2

Reference substance name:

Dibutyl phenyl phosphate

EC Number:

219-772-7

EC Name:

Dibutyl phenyl phosphate

Cas Number:

2528-36-1

Molecular formula:

C14H23O4P

IUPAC Name:

dibutyl phenyl phosphate

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 or test system 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.