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Acute Toxicity: inhalation

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acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study has been performed according to OECD and EC guidelines and according to GLP principles.

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to guideline
Principles of method if other than guideline:
Organisation for Economic Co-operation and Development
(OECD), OECD Guidelines for Testing of Chemicals, Section 4,
Health Effects. No.403, "Acute Inhalation Toxicity", Draft
document, 1996.

European Community (EC), Council Directive 67/548/EEC, Annex V,
Part B, Methods for the Determination of Toxicity, as
last amended by Commission Directive 92/69/EEC, B2: "Acute
Toxicity-Inhalation". Official Journal of the European
Communities No. L 383, 1992.

EPA Health Effects Test Guidelines OPPTS 870.1300, Acute
inhalation Toxicity. EPA 712-C-98-193, August 1998.

Japanese Ministry of Agriculture, Forestry and Fisheries
(JMAFF), 12 Nousan, Notification No 8147, November 2000,
including the most recent partial revisions.
GLP compliance:
yes (incl. QA statement)
Limit test:

Test material

Constituent 1
Reference substance name:
EC Number:
EC Name:
Molecular formula:
5,11,17,23,29,35,41,47-octa-tert-butyl-49,50,51,52,53,54,55,56-octahydroxy-2λ⁶,8λ⁶,14λ⁶,20λ⁶,26λ⁶,32λ⁶,38λ⁶,44λ⁶-octathianonacyclo[³,⁷.1⁹,¹³.1¹⁵,¹⁹.1²¹,²⁵.1²⁷,³¹.1³³,³⁷.1³⁹,⁴³]hexapentaconta-1(49),3,5,7(56),9,11,13(55),15,17,19(54),21(53),22,24,27,29,31(52),33,35,37(51),39(50),40,42,45,47-tetracosaene-2,2,8,8,14,14,20,20,26,26,32,32,38,38,44,44-hexadecone; 5,11,17,23-tetra-tert-butyl-25,26,27,28-tetrahydroxy-2λ⁶,8λ⁶,14λ⁶,20λ⁶-tetrathiapentacyclo[³,⁷.1⁹,¹³.1¹⁵,¹⁹]octacosa-1(25),3,5,7(28),9,11,13(27),15(26),16,18,21,23-dodecaen-2,2,8,8,14,14,20,20-octone
Details on test material:
- Name of test material (as cited in study report): TC4ASO2
- Substance type: multi-constituent
- Physical state: white powder
- Analytical purity: 100%
- Composition of test material, percentage of components: 95% 4-tert-Butylsulfonylcalix(4)arene (CAS 204190-49-8)
5% 4-tert-Butylsulfonylcalix(8)arene
- Lot/batch No.: AYUI-2Y
- Expiration date of the lot/batch: 08 July 2009
- Stability under storage conditions: Stable
- Storage condition of test material: At room temperature in the dark

Physical form of substance: S
Mass median aerodynamic diameter (for liq.+solid aerosol):
Samples for characterisation of the particle size
distribution were taken twice. The mass median aerodynamic
diameter (MMAD), the diameter at which the cumulative
percentage amounts to 50%, was read from the graphs and was
estimated to be 2.0 mm in both occasions. The particle size
distribution was not log-normally distributed and thus a
geometric standard deviation could not be calculated.

Test animals

other: Rat, Wistar strain Crl:WI

Administration / exposure

other: No vehicle was used.
Details on inhalation exposure:
Duration of exposure:
4 h

Results and discussion

Effect levels
Dose descriptor:
Effect level:
> 5 mg/L air
Exp. duration:
4 h
Male: 5 mg/L; Number of animals: 5; Number of deaths: 2
Female: 5 mg/L; Number of animals: 5; Number of deaths: 0
Clinical signs:
other: Signs of toxicity related to dose levels: During exposure: no clinical signs were noted. After exposure: hunched posture, lethargy, piloerection, ptosis, chromodacryorrhoea on the snout, slow breathing, laboured respiration and tremors. Two males
Gross pathology:
Effects on organs:
Macroscopic post mortem examination of the surviving animals
at termination did not reveal any treatment related
abnormalities. Advanced autolysis was found among the
animals that died during the study.

Any other information on results incl. tables

The mean actual concentration was 5.0 +/- 0.9 mg/l
(gravimetrically determined). The nominal concentration
was 9.2 mg/l. The generation efficiency (ratio of actual and
nominal concentration) was 52%.

Body weight loss was shown by all animals during the first
week after exposure, in males more severe than in females.
At the end of the second week after exposure body weights
had recovered to pre-treatment values in two males and two
females and were increased in the remaining animals.

Applicant's summary and conclusion

Interpretation of results:
not classified
Migrated information Criteria used for interpretation of results: EU