Registration Dossier

Diss Factsheets

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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report date:
2014

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
OGYI/38593-5/2012
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
rel-(6R,7R,15R,16R,24R,25R,33R,34R,42R,43R,59R,64R,65R,69R,70R,75R)-41,44,46,48,50,52,54,56,58,1,61,63,66,68,71,39,37,35,32,30,28,26,23,21,19,17,14,12,10,8,5,3-dotriacontaazapentacosacyclo[39.18.13.1^(5,17).1^(8,58).1^(14,26).1^(23,35).1^(32,44).1^(56,59).1^(63,66).1^(68,71).0^(7,3).0^(10,6).0^(16,12).0^(19,15).0^(25,21).0^(28,24).0^(34,30).0^(37,33).0^(42,46).0^(43,39).0^(48,70).0^(50,69).0^(52,65).0^(54,64).0^(61,75)]octacontane-45,49,53,57,60,40,36,31,27,22,18,13,9,4,73,74-hexadecone hydrochloride hydrate
EC Number:
700-970-1
Molecular formula:
C48N32H48O16xH2O
IUPAC Name:
rel-(6R,7R,15R,16R,24R,25R,33R,34R,42R,43R,59R,64R,65R,69R,70R,75R)-41,44,46,48,50,52,54,56,58,1,61,63,66,68,71,39,37,35,32,30,28,26,23,21,19,17,14,12,10,8,5,3-dotriacontaazapentacosacyclo[39.18.13.1^(5,17).1^(8,58).1^(14,26).1^(23,35).1^(32,44).1^(56,59).1^(63,66).1^(68,71).0^(7,3).0^(10,6).0^(16,12).0^(19,15).0^(25,21).0^(28,24).0^(34,30).0^(37,33).0^(42,46).0^(43,39).0^(48,70).0^(50,69).0^(52,65).0^(54,64).0^(61,75)]octacontane-45,49,53,57,60,40,36,31,27,22,18,13,9,4,73,74-hexadecone hydrochloride hydrate
Test material form:
solid

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Methyl cellulose 1%
Doses:
The starting dose level (5000 mg/kg bw) was selected at the request of the Sponsor.
Initially, one female was treated at a dose level of 5000 mg/kg bw of CUCURBIT[8]URIL. The test item did not cause mortality; therefore further two
animals were treated at the same dose level. The test item did not cause mortality in these animals, so no further testing was required according to
OECD 423 and Commission Regulation (EC) NO 440/2008 of 30 May 2008, B.1.Tris.
No. of animals per sex per dose:
3 female rats were exposed to a single dose of 5000mg/kg bw
Control animals:
no

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.

Applicant's summary and conclusion

Interpretation of results:
not classified
Conclusions:
Under the conditions of this study, the acute oral LD50 value of the test item CUCURBIT[8]URIL was found to be above 5000 mg/kg bw in female
CRL: (WI) rats. According to the GHS criteria, CUCURBIT[8]URIL can be ranked as “Unclassified” for acute oral exposure.
Executive summary:

The objective of the study was to assess the toxicity of test item CUCURBIT[8]URIL when administered as a single oral gavage dose to rats. The results of the study allow the test item to be ranked according to most classification systems currently used. Study performed in accordance with the study plan, OECD 423 (17th December 2001), Commission Regulation (EC) NO 440/2008 of 30 May 2008, B.1.Tris, EPA Health Effects Test Guidelines (OCSPP 8770.1100), United States, EPA 712-C-98-190 (1998) and the Principles of Good Laboratory Practice (Hungarian GLP Regulations: 42/2014. (VIII. 19.) EMMI decree of the Ministry of Human Capacities which corresponds to the OECD GLD, ENV/MC.CHEM (98)17).

Under the conditions of this study, the acute oral LD50 value of the test item CUCURBIT[8]URIL was found to be above 5000 mg/kg bw in female CRL: (WI) rats. According to the GHS criteria, CUCURBIT[8]URIL can be ranked as “Unclassified” for acute oral exposure.