Bis(2,2,6,6-tetramethyl-4-piperidyl) sebacate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

7 days

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

yes

Remarks:

7 days observation instead of 14 days

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Bis(2,2,6,6-tetramethyl-4-piperidyl) sebacate

EC Number:

258-207-9

EC Name:

Bis(2,2,6,6-tetramethyl-4-piperidyl) sebacate

Cas Number:

52829-07-9

Molecular formula:

C28H52N2O4

IUPAC Name:

bis(2,2,6,6-tetramethylpiperidin-4-yl) sebacate

Test animals

Species:

rat

Strain:

other: Tif. RAI

Sex:

male/female

Details on test animals or test system and environmental conditions:

Age: 8-9 weeks old
Weight: 180-220 g
The males and females were segregated and kept in Macrolon cages, type 4, (9 animals to a cage) during an observation period of 7 days in a room maintained at a constant temperature of 22 ± 1 °C and a relative humidity of approximately 50 %.

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Vehicle:

other: ethanol

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: modified version of an apparatus described by Niessen et al. (Arch. Toxicol. 20, 44-60 (1963))
- Method of holding animals in test chamber: in PVC tubes positioned radially around the exposure chamber
- System of generating particulates/aerosols: A 20 % dilution in ethanol was sprayed into the exposure chamber by means of a pressure nozzle. The liquid was injected by a motor-driven syringe at a rate of 6, 12 and 30 ml/hr into a stream of compressed air (2 atm.) flowing through a spray nozzle at a rate of 10 lit./min. The aerosol mist thus produced was discharged into the exposure chamber. The animals were exposed to the test substance when the aerosol was evenly dispersed throughout the chamber (15 minutes).
- Method of particle size determination:

TEST ATMOSPHERE
- Brief description of analytical method used: The individual concentrations of the test substance and the particle-size distribution in the aerosol were determined gravimetrically. The aerosol was sampled on Membrane Filters, pore size 0.2 µm hourly after the beginning of the test.
- Samples taken from breathing zone: yes

VEHICLE
- Composition of vehicle (if applicable): ethanol

Analytical verification of test atmosphere concentrations:

yes

Remarks:

hourly

Duration of exposure:

4 h

Concentrations:

measured concentrations: 232 ± 46, 394 ± 72 and 887 ± 138 mg/m³

No. of animals per sex per dose:

9

Control animals:

yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

500 mg/m³ air

Exp. duration:

4 h

Mortality:

No animals died after exposure to 232 mg/m³. One animal per sex died within the first 4-hour while exposed to 394 mg/m³. All animals died within the first 4-hour while exposed to 887 mg/m³.

Clinical signs:

other: After 4-hour exposure all rats showed dyspnoea, salivation, trismus, tremor and sedation with a dose-dependent intensity. The surviving animals recovered within 24 hours. Animals treatment with ethanol alone did not show any effect.

Body weight:

No data

Gross pathology:

Dead animals: slight pulmonary edema
Killed animals: no substance related gross organ changes.

Any other information on results incl. tables

Mean particle size distribution (cascade impactor):

232 mg/m³: 29%: > 7 µm; 14%: 3 -7 µm; 14%: 1 -3 µm; 43%: < 1 µm

394 mg/m³: 10% > 7 µm; 27%: 3 -7 µm; 36%: 1 -3 µm; 27%: 1 µm

887 mg/m³: 17% > 7 µm; 21%: 3 -7 µm; 28%: 1 -3 µm; 34%: 1 µm

Applicant's summary and conclusion

Conclusions:

The LC50 was established to be 500 mg/m³ (0.5 mg/l). Based on a split-entry apporach, classification is not required.