Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not specified
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
1960

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Not specified
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
α-d-Glucopyranosiduronic acid, (3β,20β)-20-carboxy-11-oxo-30-norolean-12-en-3-yl 2-O-β-d-glucopyranuronosyl-, dipotassium salt
EC Number:
272-296-1
EC Name:
α-d-Glucopyranosiduronic acid, (3β,20β)-20-carboxy-11-oxo-30-norolean-12-en-3-yl 2-O-β-d-glucopyranuronosyl-, dipotassium salt
Cas Number:
68797-35-3
Molecular formula:
C42H62O16.2K
IUPAC Name:
α-d-Glucopyranosiduronic acid, (3β,20β)-20-carboxy-11-oxo-30-norolean-12-en-3-yl 2-O-β-d-glucopyranuronosyl-, dipotassium salt
Constituent 2
Reference substance name:
unknown constituent
IUPAC Name:
unknown constituent
Specific details on test material used for the study:
Products of Maruzen Pharmaceuticals Company limited

Test animals

Species:
mouse
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
Weight : between 13 and 17 g

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
With the use of stomach canula, the 10% solution was administered orally.
Doses:
4000, 4500, 5000, 5500, 6000, 6500, 7000 mg/kg dose
No. of animals per sex per dose:
6 healthy mice was used for each materials
Control animals:
not specified
Details on study design:
The animals were kept 7 days after administration of the treatment and observed after 168hours for the mortality.
Statistics:
LD50 and confidence limit at 95% were calculated by Lictchfield-Wilcoxon method.

Results and discussion

Preliminary study:
Not specified
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 8 100 mg/kg bw
Based on:
test mat.
95% CL:
>= 7 700 - <= 8 500
Mortality:
For each group given 5000 mg/kg and 6500 mg/kg doses, only onse mouse of eac group died but the rest survived. At above 7000 mg/kg dose animal started dying.
Clinical signs:
other: Not specified
Gross pathology:
Not specified
Other findings:
Not specified

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

The acute oral LD50 of the substance is 8100 mg/kg bw in mice. The test item exhibit extremely low toxicity.