1-acetyl-4-(3-dodecyl-2,5-dioxo-1-pyrrolidinyl)-2,2,6,6-tetramethylpiperidine

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1991

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

GLP compliance:

yes

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-acetyl-4-(3-dodecyl-2,5-dioxo-1-pyrrolidinyl)-2,2,6,6-tetramethylpiperidine

EC Number:

411-930-5

EC Name:

1-acetyl-4-(3-dodecyl-2,5-dioxo-1-pyrrolidinyl)-2,2,6,6-tetramethylpiperidine

Cas Number:

106917-31-1

Molecular formula:

C27H48N2O3

IUPAC Name:

1-(1-acetyl-2,2,6,6-tetramethylpiperidin-4-yl)-3-dodecylpyrrolidine-2,5-dione

Details on test material:

Physical form of substance: L
Mass median aerodynamic diameter (for liq.+solid aerosol):
(MMAD) 2,7 µg, og 2,03

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River UK Ltd., England
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 6 and 8 weeks
- Weight at study initiation: 200 g
- Housing: in stainless steel cages with sheet material forming the sides and welded wire mesh forming the front, back and floor
- Diet (e.g. ad libitum): SDS RM1, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-25°C
- Humidity (%): 35-65%

IN-LIFE DATES:
From: 24.0.4 To: 14.05.1991

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

whole body

Vehicle:

other: 80 % solution in acetone

Mass median aerodynamic diameter (MMAD):

2.7 µm

Geometric standard deviation (GSD):

2.03

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Aerosol generator
- Exposure chamber volume: approx. 120 L
- Method of holding animals in test chamber: Each chamber was divided by wire mesh partitions to provides 10 separate animal compartments. The test atmosphere entered through a port at the base centre of the chamber and passed out through small holes in the lower edge of the square section. Each chamber was positioned inside a large glass walled cabinet equipped with an extract fan exhausting to atmosphere through a collection filter.
- Source and rate of air: supply of clean dried air; 25 L/min
- System of generating particulates/aerosols: aerosol generator
- Method of particle size determination: Samples were taken using a Marple model 296 cascade impactor and the material collected on the stages was weighed and analysed chemically to determine the particle size distribution
- Treatment of exhaust air: 23-24°C


VEHICLE
- Composition of vehicle (if applicable): air


TEST ATMOSPHERE (if not tabulated)
- MMAD (Mass median aerodynamic diameter): 2.7 µm +/- 2.03

Analytical verification of test atmosphere concentrations:

yes

Remarks:

gravimetric and chemical analysis

Duration of exposure:

4 h

Remarks on duration:

Observation period 14 days post exposure

Concentrations:

Atmosphere concentration: 2.61 mg/l of air (88 % of the droplets were respirable. MMAD = 2.7 µm)

No. of animals per sex per dose:

One control group and 1 test group each of 5 male and 5 female rats.

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
clinical signs: 2/day
body weight: daily
- Necropsy of survivors performed: yes
- Other examinations performed:
histopathology: lungs, liver, kidneys
- Organ weight:
lungs

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 2.61 mg/L air

Exp. duration:

4 h

Mortality:

Male: 2.61 mg/L; Number of animals: 5; Number of deaths: 0
Female: 2.61 mg/L; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: (a) During exposure: The signs were consistent with exposure to a mildly irritant aerosol and included partial closing of the eyes, wetness around the eyes and snout and abnormal respiratory movements. (b) During the observation period: Signs observed fol

Body weight:

Reduced bodyweight or rate of bodyweight gain was seen in some male rats for 1 day following exposure.

Gross pathology:

Macroscopic pathology: No treatment-related findings.
Microscopic pathology: No treatment-related findings.

Other findings:

Food and water consumption: Food consumption was reduced in males only for 1 day following exposure to the substance. Water consumption was reduced overnight following exposure.

Lung weight to bodyweight ratio: The lung weight to bodyweight ratio for all rats exposed to the substance was considered to be within normal limits.

There were no deaths during the study.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

For the test substance, the LC50 (4-hour) was determined to be > 2.61 mg/l of air.

Executive summary:

For the test substance, the LC50 (4-hour) was determined to be > 2.61 mg/l of air in the acute inhalation toxicity study. There were no deaths during the study. Considering pathology, no treatment-related findings were observed.