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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Acute Oral Toxicity: LD50 >5000 mg/kg bw female Wistar rats.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
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
Species:
rat
Strain:
Wistar
Sex:
female
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
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD0
Value:
5 000 mg/kg bw
Quality of whole database:
1. Experimental study performed in accordance with OECD Guideline 423, EU Method B1. Tris and US EPA Procedure OCSPP 870.1100 in compliance with GLP.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute Oral Toxicity

The single-dose oral toxicity of CUCURBIT[8]URIL was performed according to the acute toxic class method in CRL: (WI) rats.

Initially, one female was treated at a dose level of 5000 mg/kg bw CUCURBIT[8]URIL. The test item did not cause mortality; therefore two further 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.

A single oral treatment was carried out by gavage for each animal after an overnight food withdrawal. Food was made available again 3 hours after the treatment. The test item was administered formulated in Methyl cellulose 1% at a concentration of 500 mg/mL at a dosing volume of 10 mL/kg bw.

Clinical observations were performed at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter. Body weight was measured on Days -1, 0 and 7 and Day 14 before necropsy. All animals were subjected to a necropsy and a macroscopic examination.

 

Results

Mortality: CUCURBIT[8]URIL did not cause mortality at the dose level of 5000 mg/kg bw.

Clinical observations: Treatment with CUCURBIT[8]URIL at a dose level 5000 mg/kg bw did not cause any test item related effects on the animals.

Body weight and body weight gain: Body weight gains of CUCURBIT[8]URIL treated animals during the study showed no indication of a treatment-related effect.

Macroscopic Findings: There was no evidence of the macroscopic observations at a dose level of

5000 mg/kg bw.

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.


Justification for selection of acute toxicity – oral endpoint
Full experimental GLP study report.

Justification for classification or non-classification

Acute Oral Toxicity

According to the GHS criteria, CUCURBIT[8]URIL can be ranked as “Unclassified” for acute oral exposure.