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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline, acceptable with restrictions (Body weight was not determined after 7 days observation, only after 14 days)

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:
Body weight was not determined after 7 days observation, only after 14 days. Not all particles within respirable range of rats.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate
EC Number:
218-216-0
EC Name:
Octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate
Cas Number:
2082-79-3
Molecular formula:
C35H62O3
IUPAC Name:
octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate

Test animals

Species:
rat
Strain:
other: Tif. RAI
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY Limited, Breeding unit
- Weight at study initiation: 227-244 g
- Diet (e.g. ad libitum): rat food, NAFAG, Gogsau SG
- Water (e.g. ad libitum): drinking water
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±1
- Humidity (%): 50±5
- Photoperiod (hrs dark / hrs light): 14/10

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose only
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Method of holding animals in test chamber: For inhalation the rats were kept in separate PVC tubes positioned radially around the exposure chamber such that snout and nostrils of the animals only were exposed to the aerosol.
- System of generating particulates/aerosols: The aerosol was generated by injecting the solid test material with the help of a "Grafix Exaktomat Injector" into an air stream which was discharged into the exposure chamber through a nozzle under a pressure of 2 atm. at a rate of 20 L/min.
- Method of particle size determination: The size distribution of the particles was measured with a Cascade Impactor with Selectron filters of 25 mm diameter and with a pore size of 0.2 µm at an air flow rate of 17.5 L/min.
- Temperature, humidity in air chamber: 27-28 °C, 19-21 %

TEST ATMOSPHERE
- Brief description of analytical method used: The concentration and the particle size distribution of the aerosol in the vicinity of the animals were monitored at 1 hour intervals throughout the aerosol exposure. The concentration was determined gravimetrically.
- Samples taken from breathing zone: yes

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: 7-12% of the test atmosphere were >7 µm, 38-45 % were 1-3 µm, 32-45 % were 3-7 µm, and 4-15 % were 0-1 µm
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
500, 1025 and 1811 mg/m3 (0.5, 1.025 and 1.811 mg/L)
No higher concentrations possible.
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Physical condition and incidence of death were monitored throughout an observation period of 14 days. Body weight only before treatment and at 14 days.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 1.81 mg/L air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: 45% less than 3 µm; no higher concentrations were possible.
Mortality:
no mortalities occurred
Clinical signs:
other: Exophthalmos, ruffled fur and ventral body position were observed.
Body weight:
Animals gained normal body weight.
Gross pathology:
No substance related gross organ changes were observed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information