Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 807-654-3 | CAS number: 1627851-18-6
Toxicological information
Acute Toxicity: oral
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:
- 2 014
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
- 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
Constituent 1
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
