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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20 May - 04 Jun 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-guideline study

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
adopted in 2001
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
adopted in 2008
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Groupe interministeriel des produits chimiques, Ivry sur Seine, France
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
(2R,3R,4S,5S,6R)-2-(heptyloxy)-6-(hydroxymethyl)oxane-3,4,5-triol; (2R,3R,4S,5S,6R)-2-{[(2R,3S,4S,5R,6R)-6-(heptyloxy)-3,4,5-trihydroxyoxan-2-yl]methoxy}-6-(hydroxymethyl)oxane-3,4,5-triol; (2R,3R,4S,5S,6R)-2-{[(2R,3S,4S,5R,6R)-6-{[(2R,3S,4S,5R,6R)-6-(heptyloxy)-3,4,5-trihydroxyoxan-2-yl]methoxy}-3,4,5-trihydroxyoxan-2-yl]methoxy}-6-(hydroxymethyl)oxane-3,4,5-triol
EC Number:
807-654-3
Cas Number:
1627851-18-6
Molecular formula:
(C6H10O5)nC7H16O, n - number of D-glucopyranose units
IUPAC Name:
(2R,3R,4S,5S,6R)-2-(heptyloxy)-6-(hydroxymethyl)oxane-3,4,5-triol; (2R,3R,4S,5S,6R)-2-{[(2R,3S,4S,5R,6R)-6-(heptyloxy)-3,4,5-trihydroxyoxan-2-yl]methoxy}-6-(hydroxymethyl)oxane-3,4,5-triol; (2R,3R,4S,5S,6R)-2-{[(2R,3S,4S,5R,6R)-6-{[(2R,3S,4S,5R,6R)-6-(heptyloxy)-3,4,5-trihydroxyoxan-2-yl]methoxy}-3,4,5-trihydroxyoxan-2-yl]methoxy}-6-(hydroxymethyl)oxane-3,4,5-triol
Test material form:
other: solid, not further specified
Details on test material:
- Name of test material (as cited in study report): Heptylglucoside
- Physical state: brown solid
- Analytical purity: >99% dry matter
- Lot/batch No.: 3675JG
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
other: Sprague Dawley-SPF Caw
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Elevage Janvier Labs, Le Genest St. Isle, France
- Age at study initiation: eight weeks
- Weight at study initiation: 195.2 (mean)
- Fasting period before study: from Day -1 to 4 h after the test administration
- Housing: in groups of three in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid; sawdust bedding.
- Diet (e.g. ad libitum): foodstuff (Safe, A04), ad libitum (except during the fasting period)
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30- 70
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: distilled water
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

DOSAGE PREPARATION: in the first and second step of the study, 2.0029 g and 2.0001 g of the test item was weighed and distilled water was added to two 10 mL volumetric flask, respectively. Preparations were magnetically stirred to obtain a yellow solution just before the administration.

Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6 (females)
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were weighed on day 0 (just before administration), on day 2, 7, and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: LD50 cut-off according to OECD 423 may be considered higher than 5000 mg/kg bw.
Mortality:
No mortality occurred during the study period.
Clinical signs:
other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.
Gross pathology:
2000 mg/kg bw: a thinning of the forestomach was noted in two animals (2/6) during the macroscopic examination of the animals at the end of the study. This finding is not unusual in this type of study and is not considered a major sign of systemic toxicity.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified