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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 458-930-1 | 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://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29-07-1985/16-08-1985
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Principles of method if other than guideline:
- The method described by Hagan et al.1976 served as a guide.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
Test material
- Details on test material:
- - Name of test material (as cited in study report): Tridecyl Neopentanoate
- Lot/batch No.:: P100-39, 7-24-85
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: animals were provided by a licensed dealer
- Age at study initiation: approximately 6 to 9 weeks old
- Weight at study initiation: between 120 and 220 g/bw
- Fasting period before study: 18 hours
- Housing: animals were housed in galvanized cages with indirect bedding
- Diet (e.g. ad libitum): growth and maintenance ration from a commercial producer
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled
- Humidity (%) and air changes (per hr): not provided
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
Upon receipt, animals were carefully checked for respiratory difficulty, ocular and nasal lacrimation, dehydration, diarrhoea and general thriftiness.
Administration / exposure
- Route of administration:
- other: The dose was administrated using a stainless steel intragastric feeding needle
- No. of animals per sex per dose:
- 5 male, 5 female
- Details on study design:
- Twenty-four hours prior the test, the animals were screened for general thriftiness and a group of 5 males and 5 females of sufficient weight was selected and labelled for the experiment.
After 18 hours of fasting, each rat was weighted and marked with an ear clip. Individual doses were calculated on the bases of the bodyweight. The dose was administrated using a stainless steel intragastric feeding needle. After that, rats were returned to their cages, which were identified with the job number, test article, dose level, sex, animal number and date of dosing.
Animals were observed for signs of pharmacologic activity and toxicity at 1,3,6 and 24 hours post dosage. Observations were made at least once daily for 14 consecutive days.
Animals were sacrificed at the end of the 14 day observation period and gross necropsy was performed.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Remarks on result:
- other: 0% Mortality
- Mortality:
- No mortality occurred during this study
- Clinical signs:
- No changes were observed during this study
- Body weight:
- Animals gain weight normally during this study.
- Gross pathology:
- No gross changes were observed
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The Acute oral LD50 of Ceraphyl 55 is for rats >5000 mg/kg.
- Executive summary:
Acute oral toxicity was determined in GLP compliant study OECD 420 using 5 female and 5 male Wistar Albino rats (age 6 to 9 weeks and weight between 120 and 220). The test substance was administered neat as a single dose using a stainless steel intragastric feeding needle (5000 mg/kg bwt) following an overnight fast, and the animals observed for 14 days post-treatment. There were no deaths or any clinical signs noted following treatment and the animals gained weight normally. No gross abnormalities were detected at autopsy on study day 14. The results showed that the acute oral LD50 of Ceraphyl 55 is greater than 5000 mg/kg bwt.
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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