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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 204-029-1 | CAS number: 113-48-4
- 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:
- 17 November 2004 to 22 Mar 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Version / remarks:
- August 1998
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 24 February, 1987
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- N-(2-ethylhexyl)-8,9,10-trinorborn-5-ene-2,3-dicarboximide
- EC Number:
- 204-029-1
- EC Name:
- N-(2-ethylhexyl)-8,9,10-trinorborn-5-ene-2,3-dicarboximide
- Cas Number:
- 113-48-4
- Molecular formula:
- C17H25NO2
- IUPAC Name:
- N-(2-ethylhexyl)-8,9,10-trinorborn-5-ene-2,3-dicarboximide
- Reference substance name:
- (E)-1,4-Bis(2-ethylhexylamino)-2-butene-1,4-dione
- Molecular formula:
- C20H38N2O2
- IUPAC Name:
- (E)-1,4-Bis(2-ethylhexylamino)-2-butene-1,4-dione
- Reference substance name:
- 1-(2-ethylhexyl)-1H-pyrrole-2,5-dione
- Molecular formula:
- C12H19NO2
- IUPAC Name:
- 1-(2-ethylhexyl)-1H-pyrrole-2,5-dione
- Test material form:
- liquid
- Details on test material:
- Purity and characterisation analysis conducted on the following sample; Supplier: McLaughlin Gormley King ; Batch Number: AB9500
Constituent 1
impurity 1
impurity 2
- Specific details on test material used for the study:
- MGK 264
Lot No.: AA-7093
Purity: 95.2% MGK 264 (From CofA)
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Description, Identification and Housing
Adult, Hsd: Sprague Dawley® SD® rats were received from Harlan Sprague Dawley, Inc., Indianapolis. IN. Upon receipt, metal ear tags displaying unique identification numbers were used to individually identify the animals. Cage cards displaying at least the study number, animal number and sex were affixed to each cage. The animals were housed individually in suspended stainless steel cages. All housing and care were based on the standards recommended by the Guide for the Care and Use of Laboratory Animals.
Environment, food and water
The animal room temperature and relative humidity ranges were 64-71°F (18-22°C) and 40-61 %. respectively. Environmental control equipment was monitored and adjusted as necessary to minimize fluctuations in the animal room environment. Light timers were set to maintain a 12-hour Iightll2-hour dark cycle and room ventilation was set to produce 10-15 air changes/hour. The animal room temperature and relative humidity were recorded a minimum of once daily. Food and Water provided ad libitum.
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- On the day following clipping of the fur from the dorsal trunk (day 0), the test article was administered dermally to approximately 10% of the body surface area. The four comers of this area were delineated in the clipped area with an indelible marker. The test article was then spread evenly over the delineated test area and held in contact with the skin with an appropriately sized 4-ply porous gauze dressing backed with a plastic wrap which was placed over the gauze dressing (occlusive binding). Removal and ingestion of the test article was prevented by placing an elastic wrap over the trunk and test area. The elastic wrap was further secured with a tape harness on the cranial end of the trunk and then secured with adhesive tape around the trunk at the caudal end.
- Duration of exposure:
- After an approximate 24-hour exposure period, the binding materials were removed and the corners of the test site were re-delineated using a marker. Residual test article was removed using gauze moistened with deionized water followed by dry gauze.
- Doses:
- 5000 mg/kg
- No. of animals per sex per dose:
- 5 males and 5 females per dose.
- Control animals:
- no
- Details on study design:
- The single-dose dermal toxicity of MGK® 264 was evaluated in Sprague Dawley rats. A limit test was performed in which one group of five male and five female rats received a single dermal administration of the test article at a dose of 5000 mg/kg body weight. Following dosing, the limit test rats were observed daily and weighed weekly. A gross necropsy examination was performed on all animals at the time of scheduled euthanasia (day 14).
- Statistics:
- Data from the limit test were analyzed and an LD50 value estimated as follows:
< 50% Mortality: LD50 was estimated as greater than the administered dose.
= 50% Mortality: LD50 was estimated as equal to the administered dose.
> 50% Mortality: LD50 was estimated as less than the administered dose.
Body weight means and standard deviations were calculated separately for males and females.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- other: LD50 found to be greater than 5000 mg/kg
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality occurred during the limit test.
- Mortality:
- No mortality occurred during the limit test.
- Clinical signs:
- Clinical abnormalities observed during the study included transient incidences of dark material around the facial area and ocular discharge. Dermal irritation was noted at the site of test article application.
- Body weight:
- Body weight gain was noted for all animals during the test period.
- Gross pathology:
- No gross internal findings were observed at necropsy on study day 14.
Applicant's summary and conclusion
- Interpretation of results:
- other: No symbol and risk phrases are required according to EEC labelling regulations. (EC 1272/2008)
- Conclusions:
- The acute dermal lethal dose (LD50) of the test material, in male and female Sprague-Dawley rats was found to be greater than 2000 mg/kg bodyweight. No symbol and risk phrases are required according to EEC labelling regulations. (EC 1272/2008)
- Executive summary:
The single-dose dermal toxicity of MGK® 264 was evaluated in Sprague Dawley rats. A limit test was performed in which one group of five male and five female rats received a single dermal administration of the test article at a dose of 5000 mg/kg body weight. Following dosing, the limit test rats were observed daily and weighed weekly. A gross necropsy examination was performed on all animals at the time of scheduled euthanasia (day 14).
No mortality occurred during the limit test.
The acute dermal lethal dose (LD50) of the test material, in male and female Sprague-Dawley rats was found to be greater than 2000 mg/kg bodyweight. No symbol and risk phrases are required according to EEC labelling regulations. (EC 1272/2008)
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.