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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
pentyl 6-deoxy-alpha-L-mannopyranoside
EC Number:
700-713-3
Cas Number:
83161-22-2
Molecular formula:
C11H22O5
IUPAC Name:
pentyl 6-deoxy-alpha-L-mannopyranoside
Details on test material:
For technical reason (solubility), APRC5 was diluted at 30% in a water/glycerol (1/5) mixture
This mixture corresponds to the industrial form.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: water/glycerol mixture
Doses:
2000 mg/kg
No. of animals per sex per dose:
3 animals per dose
Control animals:
no
Details on study design:
At the first step, a group of 3 animals was treated with the starting dose of 2000 mg.kg body weight, followed by an additionnal group of 3 animals at the same dose level.
General observation were performed twice on Day 1 (60 min ± 30 min post-dose and again between 3 and 4h post-dose), and then daily for 14 days after administration of the test item. Functional and neurobehavioural tests were performed on Day 1 (60 min ± 30 min post-dose), on Day 7 and on Day 14. Animals were weighted on Days 1, 7, 14 and 15 (day of necroscopy).
Statistics:
All animals surviving ti the end of the 14-day monitoring period were submitted to gross necroscopy.

Results and discussion

Preliminary study:
No mortality was observed
Effect levels
Sex:
female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality
Clinical signs:
no clinical signs
Body weight:
No abnormality was seen in the mean weight gain
Gross pathology:
No organ or tissue gross findings were seen at necroscopy

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No mortality is observed in experimental conditions