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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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EC number: 700-891-2 | 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 2008/06/03 to 2008/06/17
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No deviation occured in this study. The experimental protocol was established on the basis of the official method as defined in the OECD guideline n° 402 and was executed in compliance with the Good Laboratory principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 2007
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- acetalization product between glucose and C14 alcohol
- IUPAC Name:
- acetalization product between glucose and C14 alcohol
- Details on test material:
- Batch: T73615
Form: pearls
Colour: beige
Storage: room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Animals:
- Sprague Dawley rats originated from Elevage JANVIER (53940 Le Genest St Isle-France)
- Acclimatation period: at least five days
- Weight and old at the begenning of the study: between 219 and 246g (males and between 195 and 215 (females) and were 7-8 weeks old
Housing:
- During the treatment, the animals were kept in individual cage, at D3, the animals were put into their cage by 2 or 3.
- Each cage contains sawdust bedding which was changed at least 2 times a week.
- Environmental conditions:
T° between 19 and 23°C
relative humidity between 41 and 69%
lighting time: 12 hours daily
rate of air exchange: at least ten changes per hour
Food and drinking:
- Drinking water and foodstuff were supplied freely
- Microbiological and chemical analyses of the water were carried out once every six months by the Institut Européen de l'Environnement de Bordeaux
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- paraffin oil
- Details on dermal exposure:
- Animal from group 2 (treated) received by topical application, under porous gauze dressing, an effective dose of 2000mg/kg body weight of LCE 08083, previously heated at 50°C, diluted in liquid paraffin and administrated under a volume of 10mL/kg body weight, during 24 hours. After a 24 hours exposure period, the gauze dressings were removed.
Animals from group 1 (control) received in the same experimental conditions the vehicle (liquid paraffin) under a volume of 2.32 mL/kg body weight. - Duration of exposure:
- 24 hours
- Doses:
- 2000mg/ kg body weight
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- Daily examination:
Systematic examination were carried out to identify any behavioural or toxic effects on the major physiological functions 5 days after administration of the test solution.
This examination focuses particularly on a list of symptoms, recorded as "present" or "absent" on the observation sheet.
These observations were compared to control data.
Observations and a mortality report were then carried out every day for 14 days.
Periodical examinations:
the animals were weighed on day D0 (just before administering the test item) then on D2, D7, and D14.
Weight changes were calculated and recorded.
Examination at the end of the test:
On D14, macroscopic observations were entered on individual autopsy sheets.
Only those organs likely to be modified in cases of acute toxicity were examined. Thoses presenting macroscopic anomalies can be removed and preserved in view to microscopic examinations.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occured during the study.
- Clinical signs:
- other: No clinical signs related to the administration of the test item were observed. It was noted a slight erythema, on the treated area, 24 hours after the test item administration in all treated animals. The treated areas have recovered a normal aspect betwe
- Gross pathology:
- The macroscopical examination of the animals at the end of the study did not revealed treatment-related changes.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information LD 50 >2000mg/kg body weight Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 of the test substance is higher than 2000 mg/kg body weight by dermal route in the rat.
According to the criteria for classification, packaging and labelling of dangerous substances and preparations in accordance with the E.E.C. Directives 67/548, 2001/59 and 99/45 and regulation 1272/2008, the test substance needs not be classified. No symbol and risk phrase are required. - Executive summary:
The test item was applied onto the intact skin of 10 Sprague Dawley rats (5 males and 5 females) at the single dose of 2000mg/kg body weight. The experimental protocol was established on the basis of the official method as defined in the OECD guideline n° 402 dated February 24th, 1987 and the test method B.3 of the directive n°92/69/EEC.
No mortality occured during the study.
No systemic clinical signs related to the administration of the test item were observed.
it was noted a slight arythema, on the treated area, 24 hours after the test item administration in all treated animals. The treated areas have recovered a normal aspect between treated and control animals.
The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.
In conclusion, the LD50 oh the test item is higher than 2000mg/kg body weight by dermal route in the rat.
According to the criteria for classification, packaging and labelling of dangerous substances and preparations in accordance with the E.E.C. Directives 67/548, 2001/59 and 99/45, and regulation 1272/2008 the test item need not to be classified. No symbol and risk phrase are required.
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.
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