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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Endpoint summary
Administrative data
Description of key information
An OECD 404 study was performed in rabbits in order to determine the irritation properties of MGK 264 when applied undiluted to the skin. The mean values for erythema were less than 2 and the mean values for oedema were less than 1. All findings were reversible within a 7 day scoring interval. Based on the results of this study MGK 264 may be classified as non-irritating to the skin.
An OECD 405 study was performed in rabbits in order to determine the irritation properties of MGK 264 when applied undiluted to the eye. The mean values for corneal opacity and iritis were 0, the mean values for conjunctival redness were less than or equal to 1 and the mean values for conjunctival oedema were less than 1. Based on these results MGK 264 may be classified as non-irritating to the eye.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 Nov 2004 to 10 Mar 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- not specified
- GLP compliance:
- yes
- Specific details on test material used for the study:
- MGK 264
Lot No.: AA7093
Purity: 95.2% MGK 264 (From CofA) - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- 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.
The animal room temperature and relative humidity ranges were 70-72°F (21-22°C) and 34-55%, 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 12h ligh/12h 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. - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Remarks:
- On day -1, the animals chosen for use on the primary skin irritation study had the fur removed from the dorsal area of the trunk using an animal clipper. Care was taken to avoid abrading the skin during the clipping procedure.
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- The test material was administered as received from the Sponsor.
- Amount / concentration applied:
- 0.5mL at 100% concentration (as received), over approximately 1 inch x 1 inch
- Duration of treatment / exposure:
- After a four-hour exposure period, the binding materials were removed from each animal and the corners of the test site delineated using a marker. Residual test article was removed using gauze moistened with deionized water, followed by dry gauze.
- Observation period:
- Animals were examined for signs of erythema and edema and the responses scored at I hour after patch removal and 24, 48, 72 hours, and 7 days after patch application according to the Macroscopic Dermal Grading System.
- Number of animals:
- 3, Male
- Details on study design:
- Preperation
Fur shorn with animal clippers
Application
0.5mL at 100% concentration (as received), over approximately 1 inch x 1 inch.
Exposure
The dose was held in contact with the skin under a semi-occlusive binder for an exposure period of four hours. After a four-hour exposure period, the binding materials were removed from each animal and the corners of the test site delineated using a marker. Residual test article was removed using gauze moistened with deionized water, followed by dry gauze. Acetone was used to remove sticky tape residue outside of the test area.
Observation
Animals were examined for signs of erythema and edema and the responses scored at I hour after patch removal and 24, 48, 72 hours, and 7 days after patch application according to the Macroscopic Dermal Grading System - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Reversibility:
- fully reversible within: 7 day scoring interval
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Reversibility:
- fully reversible within: 7 day scoring interval
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Reversibility:
- fully reversible within: 7 days scoring interval
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: no irritation
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 7 day scoring window
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 7 day scoring window
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Exposure to the test article produced well-defined erythema on 3/3 test sites at the 1h scoring interval and very slight edema on 2/3 test site at the 24h scoring interval. The dermal irritation resolved completely on all test sites by the study day 7 scoring interval.
- Other effects:
- Additional dermal findings included desquamation, which was noted on 3/3 test sites.
- Conclusions:
- Based on the EEC Evaluation Criteria, MGK® 264 is classified as a non-irritant to the skin of the rabbit for erythema and edema as is indicated in the result summary table.
- Executive summary:
Summary:
Mean Irritation Scores in Individual Animals Animal No./Sex Erythema Edema R27571M 1.67 0.00 R2763/M 1.67 0.33 R27651M 1.67 0.33 Irritation Rating Nonirritant Nonirritant
Reference
Summary:
Mean Irritation Scores in Individual Animals | ||
Animal No./Sex | Erythema | Edema |
R27571M | 1.67 | 0.00 |
R2763/M | 1.67 | 0.33 |
R27651M | 1.67 | 0.33 |
Irritation Rating | Nonirritant | Nonirritant |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
MGK 264 may be classified as non-irritating to the skin or eye based on OECD 404 and OECD 405 compliant experimental studies.
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.