1,4-dihydroxy-2,2,6,6-tetramethyl piperidinium-2-hydroxy-1,2,3-propanetricarboxylate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2003-02-25 to 2003-05-27

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP compliant Guideline study. Deficiencies when compared to latest Guideline: - Clinical monitoring: now twice per day - Body weight: now mandatory for day 0 and at least on days 1, 3 and 7 (and weekly thereafter), and at the time of death or euthanasia if exceeding day 1.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Version / remarks:

adopted May 12, 1981

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1300 (Acute inhalation toxicity)

Version / remarks:

adopted August 1998

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

429-370-5

EC Name:

-

Cas Number:

220410-74-2

Molecular formula:

C34H67N3O13

IUPAC Name:

tris(1,4-dihydroxy-2,2,6,6-tetramethylpiperidin-1-ium) 2-hydroxypropane-1,2,3-tricarboxylate

Test material form:

other: fine white powder

Details on test material:

- Identification: FAT 76'042/C
- Description: fine white powder
- Solubility: soluble in water and acetone
- Composition of test material, percentage of components: 94.8 % active ingredient, 3.8 % water, 0.6 % other
- Lot/batch No.: E/PT103
- Expiration date of the lot/batch: August 10, 2003
- Storage: refrigerated

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ace Animals Inc., Boyertown, PA, USA
- Age at study initiation: 11-12 weeks
- Weight at study initiation: males 321-370 g and females 204-235 g
- Housing: singly in suspended stainless steel caging with mesh floors
- Diet: Purina Rodent Chow #5012, ad libitum
- Water: tap water ad libitum
- Acclimation period: 29 days

ENVIRONMENTAL CONDITIONS
- Temperature: 16-21°C
- Humidity: 38-56%
- Photoperiod: 12 h light / 12 h dark cycle

IN-LIFE DATES: From: 2003-02-26 To:2003-03-12

Administration / exposure

Route of administration:

inhalation: dust

Type of inhalation exposure:

nose only

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Mini-Nose Only inhalation Chamber, ADG Developments LTD
- Exposure chamber volume: approximately 6.7 liters (internal)
- Method of holding animals in test chamber: individually in polycarbonate holding tubes
- Source and rate of air: 28.3 liters per minute (Lpm) of compressed generator air (JUN-AIR)
- Method of conditioning air: Compressed generator air was supplied to the dust generator. An additional 3.3 Lpm of compressed mixing air, supplied using dry filtered air (WELCO), was introduced into the chamber.
- System of generating particulates/aerosols: Test item compressed to 200 lbs/sq by a Carver Lab Press Model C was packed into a DF 183 Wright Dust Container. The container was fitted witth a DF 191 Stainless Steel Cutting Blade, driven by a Dayton Model 4Z538A adiustabte speed motor.
- Method of particle size determination: eight-stage Andersen cascade impactor. Aerodynamic mass median diameter was determined graphically using two-cycle logarithmic probit axes
- Treatment of exhaust air: fed into base unit
- Temperature and humidity in air chamber: 19-21°C and 38-45 %

TEST ATMOSPHERE
- Brief description of analytical method used: gravimetric samples, collected using 25 mm glass fibre filters in a filter holder connected to a vacuum pump. The mass collected was divided by the total volume of air sampled to determine the chamber concentration. Sample airflow were measured using an Omega Flowmeter Model #FMA 5610.
- Samples taken from breathing zone: yes

TEST ATMOSPHERE
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 3.8 µm / 2.03

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

Gravimetric chamber concentration: 5.08 mg / L.

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individually prior to test substance exposure (initial) and again on days 7 and 14 (termination)
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.08 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Mortality:

All animals survived exposure to the test atmosphere.

Clinical signs:

other: Not noted

Body weight:

All animals gained body weight over the 14-day observation period.

Gross pathology:

No gross abnormalities were noted.