Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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: 946-364-2 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014-12-30 - 2015-01-20
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Version / remarks:
- 1996
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction product of D-Glucopyranoside, methyl; esterified with oleic acid, methyl ester
- EC Number:
- 946-364-2
- Molecular formula:
- C43H78O8
- IUPAC Name:
- Reaction product of D-Glucopyranoside, methyl; esterified with oleic acid, methyl ester
- Test material form:
- liquid
- Details on test material:
- - State of aggregation: yellow liquid
-Others: storage at room temperature, in the dark
Constituent 1
- Specific details on test material used for the study:
- Prior to use, the bulk test substance container was inverted and/or swirled. A sufficient amount of test substance was transferred into a storage container for dispensation.
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD(SD)
- Remarks:
- albino rat
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Inc., Raleigh, NC
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: approximately 9 weeks old
- The number of animals selected was the minimum required to satisfy regulatory guidelines.
- Weight at study initiation: ranges from 295 g to 302 g for males and 200 g to 215 g for fmales (± 20% of the mean for each sex).
- Housing: individually in clean, stainless steel, wire-mesh cages suspended above cage-board.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 70.4°F to 70.5°F (21.3°C to 21.4°C)
- Humidity (%): 32.0% to 43.0%
- Air changes (per hr): minimum 10
- Photoperiod (hrs dark / hrs light): 12 hrs light / 12 hrs dark
IN-LIFE DATES: From: 2014-12-30 To: 2015-01-20
All animals were euthanized at the end of the experimental period.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: maximum area possible on the dorsal skin.
- % coverage: at least 10 % of the total surface
- Type of wrap if used: gauze bandages (<8 ply) secured with nonirritating tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with disposable paper towels moistened with tepid tap water
- Time after start of exposure: removal 24 hrs following test substance application
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):Individual doses were calculated based on body weights taken just prior to dosing and a dose volume of 2.04 mL/kg.
- Concentration (if solution): 100 %
- Constant volume or concentration used: yes - Duration of exposure:
- 24 hrs
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 females at 2000 mg/kg
5 males at 2000 mg/kg - Control animals:
- no
- Details on study design:
- One group of 5 male and 5 female rats were dermally administered a single dose (24-hour, semi-occluded exposure) of the test item at a dose level of 2000 mg/kg (limit dose). On the day prior to dosing, the hair was removed from the backs and flanks of the rats using a small animal clipper.
- Duration of observation period following administration: 14 days
- Frequency of clinical observations and mortality:approximately 1, 2, and 4 hours post-application on study day 0 and once daily thereafter for 14 days
- Frequency of weighing: on study days 0 (initiation), 7, and 14 (termination).
- Frequency of dermal observations: The application sites were examined for erythema, edema (Draize, 1965), and other dermal findings beginning 30-60 minutes after bandage removal and daily thereafter through study day 14. The areas of application were clipped free of hair on the day prior to dosing and as needed to facilitate accurate dermal observations.
- Necropsy (of the major organ systems of the cranial, thoracic, and abdominal cavities and the skin) of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights. Tissues were not collected. Observations included, but were not limited to, evaluation for changes in appearance of skin and fur, eyes, mucous membranes, respiratory and circulatory systems, autonomic effects, and central nervous system effects
DATA ACQUISITION AND REPORTING
Program/System Description / Description
Archive Management System (AMS): In-house developed application for storage, maintenance, and retrieval of information for archived materials (e.g., lab books, study data, wet tissues, slides, etc.).
Formulations Dose Dispensing Management System (FDDMS): In-house developed system used to assign unique barcodes to formulation containers and individual containers used for dispensing dosing formulations.
InSight® Publisher: Electronic publishing system (output is Adobe Acrobat, PDF).
Master Schedule: Maintains the master schedule for the company
Metasys DDC Electronic Environmental Control System: Controls and monitors animal room environmental conditions
Microsoft® Office 2007 or higher: Used in conjunction with the publishing software to generate study reports.
Provantis Dispense™: Comprehensive system (Instem LSS Limited) to manage test materials, including receipt, formulation instructions, and accountability.
WIL Metasys: In-house developed system used to record and report animal room environmental conditions
WIL Toxicology Data Management System™ (WTDMS™): In-house developed system used for collection and reporting of in-life and postmortem data.
Results and discussion
- Preliminary study:
- not performed
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths during the study.
- Clinical signs:
- There were no clinical findings observed during the study.
- Body weight:
- There were no remarkable body weight changes noted during the study.
- Gross pathology:
- There were no macroscopic findings at the scheduled necropsy.
- Other findings:
- Dermal Observations:
Dermal findings noted during the study consisted of very slight (grade 1) to slight (grade 2) erythema and desquamation for all 5 males and 5 females. Erythema subsided by study day 6, and desquamation subsided by study day 11. In addition, female nos. 5126 and 5129 had scabbing within the dose site on study day 2 and 3, respectively. There was no edema observed at any dose site.
Any other information on results incl. tables
Table1: Acute dermal toxicity study in Albino rats, Summary of clinical findings: Total occurence/No. of animals
Table Range: Group: |
Male |
Normal |
|
No significant clinical observations |
5/5 |
Disposition | |
Scheduled euthanasia; primary (Day 14) |
5/5 |
Acutes | |
Time of Dosing | 5/5 |
Appeared normal | 85/5 |
Scheduled euthanasia; primary (Day 14) |
5/5 |
Dermal observations | |
Scored, not remarkable | 42/5 |
No erythema | 17/5 |
Erhythema - very slight | 11/5 |
No edema | 28/5 |
Desquamation | 24/5 |
Table 2: Acute dermal toxicity study in Albino rats, Summary of clinical findings: Total occurence/No. of animals
Table Range: Group: |
Female Day 0 to Day 14 1 (2000 mg/kg) |
Normal | |
No significant clinical observations |
5/5 |
Disposition | |
Scheduled euthanasia; primary (Day 14) |
5/5 |
Acutes | |
Time of Dosing | 5/5 |
Appeared normal | 85/5 |
Scheduled euthanasia; primary (Day 14) |
5/5 |
Dermal observations | |
Scored, not remarkable | 37/5 |
No erythema | 21/5 |
Erhythema - very slight | 9/5 |
Erythema - slight | 3/2 |
No edema | 33/5 |
Desquamation | 32/5 |
Scabbing within dose site | 2/2 |
Table 4: Acute dermal toxicity study in Albino rats, Summary of body weights
Group: 2000 mg/kg Males | ||
Day | ||
0 | Mean S.D. N |
298 |
7 | Mean S.D. N |
332 |
14 | Mean S.D. N |
379 |
Group: 2000 mg/kg Females |
||
Day |
||
0 |
Mean |
205 |
7 |
Mean |
218 |
14 |
Mean |
239 |
Table 5: Acute dermal toxicity study in Albino rats, Summary of body weight changes
Group: 2000 mg/kg Males | ||
Day | ||
0 to 7 | Mean S.D. N |
35 |
7 to 14 | Mean S.D. N |
47 |
Group: 2000 mg/kg Females | ||
0 to 7 | Mean S.D. N |
13 |
7 to 14 | Mean S.D. N |
21 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- limit dose 2000 mg/kg
- Conclusions:
- Based on the results of this study, the LD50 of the test item was greater than 2000 mg/kg (CLP category Unclassified) when administered once for 24 hours to the clipped, unabraded skin of male and female albino rats.
- Executive summary:
The acute dermal median lethal dose (LD50) of the test item was conducted according the EPA OPPTS Guideline 870.1200 and the OECD Guideline Section 402, in compliance with GLP.
The test item was administered once dermally for a 24-hour period under gauze dressing semiocclusive to the skin of Crl:CD(SD) albino rats to perform the limit test. The test substance was administered to one group of five male and five female rats at a dose level of 2000 mg/kg. Mortality, clinical observations, dermal findings (Draize, 1965), and body weight changes were evaluated over a 14-day observation period. All animals were subjected to a gross necropsy.
There were no deaths, clinical observations, remarkable body weight changes, or test substance-related gross necropsy findings. Dermal findings noted during the study consisted of very slight (grade 1) to slight (grade 2) erythema and desquamation for all five males and five females and scabbing within the dose site for two females.
Based on the results of this study, the LD50 of the test item was greater than 2000 mg/kg (CLP category Unclassified) when administered once for 24 hours to the clipped, unabraded skin of male and female albino rats.
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.