Hexamethylene bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non GLP study. Scientifically acceptable study report equivalent to OECD guideline 403. Specific data regarding the test substance are missing.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

yes

Remarks:

Animals were only observed for 8 days.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Hexamethylene bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]

EC Number:

252-346-9

EC Name:

Hexamethylene bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]

Cas Number:

35074-77-2

Molecular formula:

C40H62O6

IUPAC Name:

6-{[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoyl]oxy}hexyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoate

Test animals

Species:

rat

Strain:

other: RAI

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: in house breed
- Age at study initiation: 7 - 8 weeks old
- Weight at study initiation: 180 - 185 g
- Housing: groups of 9 animals in macrolon cages (Type 4)
- Diet: ad libitum,
- Water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±1
- Humidity (%): ca. 50

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: according to Niessen et al. (Arch. Toxicol. 20, 44-60 (1963))
- Method of holding animals in test chamber: separate PVC tubes
- Rate of air: 10 L/min
- System of generating particulates/aerosols: a pressure nozzle was used.
- Method of particle size determination: The particle-size distribution in the aerosol was determined gravimetrically on Selectron-Filters, pore size 0.2 µm (Schleicher and Schuell, 8714 Feldbach, Switzerland) every hour with the aid of a "Cascade Impactor" (CT. Casella and Co. Ltd., London N.l, England)

TEST ATMOSPHERE
- Samples taken from breathing zone: yes

VEHICLE
- Composition of vehicle: Ethanol
- Concentration of test material in vehicle: 20%

TEST ATMOSPHERE
- Particle size distribution: 2% >7 µm; 39% 3-7 µm; 51% 1-3 µm; 14% <1 µm

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

1688±195 mg/m3

No. of animals per sex per dose:

9

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 8 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 1.7 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Mortality:

No mortality was observed.

Clinical signs:

other: After the 4-hour exposure the rats showed lateral position and apathy. Rats that were only treated with the vehicle did not show any toxic symptoms.

Body weight:

Not determined.

Gross pathology:

No gross internal lesions were observed.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information

Conclusions:

The LC50 of the test item determined after an observation period of 7 days in rats of both sexes, exposed to the substance for four hours is greater than 1700 mg/m^3, air.