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[43.3.1.1³,⁷.1⁹,¹³.1¹⁵,¹⁹.1²¹,²⁵.1²⁷,³¹.1³³,³⁷.1³⁹,⁴³]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[19.3.1.1³,⁷.1⁹,¹³.1¹⁵,¹⁹]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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

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

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

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.423, "Acute Oral Toxicity - Acute Toxic
Class Method", 2001.



European Community (EC), Council Directive 67/548/EEC, Annex
V, Part B, Methods for the Determination of Toxicity, as
last amended by Commission Directive 2004/73/EC, B.1 tris:
"Acute Toxicity (Oral) - Acute Toxic Class Method", 2004.


United States Environmental Protection Agency (EPA). Health
Effects Test Guidelines, OPPTS 870.1100, Acute Oral
Toxicity. Office of Prevention, Pesticides and Toxic
Substances (7101), EPA 712-C-98-190, 2002.


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)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

481-490-7

EC Name:

-

Molecular formula:

multi-constituent.

IUPAC Name:

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[43.3.1.1³,⁷.1⁹,¹³.1¹⁵,¹⁹.1²¹,²⁵.1²⁷,³¹.1³³,³⁷.1³⁹,⁴³]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[19.3.1.1³,⁷.1⁹,¹³.1¹⁵,¹⁹]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: 97.8%
- Composition of test material, percentage of components: 92.9% 4-tert-Butylsulfonylcalix(4)arene (CAS 204190-49-8)
4.9% 4-tert-Butylsulfonylcalix(8)arene
- Lot/batch No.: AYUI-1Y
- Expiration date of the lot/batch: 07 October 2007
- Stability under storage conditions: Stable
- Storage condition of test material: At room temperature in the dark

Test animals

Species:

other: Rat, Wistar strain Crl:WI

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Propylene glycol (specific gravity 1.036).

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0

Clinical signs:

other: Signs of toxicity related to dose levels: Hunched posture and piloerection were noted in one animal on day 1.

Gross pathology:

Effects on organs:
No abnormalities were found at macroscopic post mortem
examination of the animals.

Any other information on results incl. tables

Comments:
One animal showed weight loss between days 8 and 15 (the
same animal that showed clinical signs on day 1). The
variation in body weight gain shown by the other animals
over the study period was considered to be similar to that
expected of normal untreated animals of the same age and
strain.


According to the OECD 423 test guideline, the LD50 cut-off
value was considered to exceed 5000 mg/kg body weight.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU