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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 207-821-5 | CAS number: 496-46-8
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation, other
- Remarks:
- GPMT
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Perhydroimidazo[4,5-d]imidazole-2,5-dione
- EC Number:
- 207-821-5
- EC Name:
- Perhydroimidazo[4,5-d]imidazole-2,5-dione
- Cas Number:
- 496-46-8
- Molecular formula:
- C4H6N4O2
- IUPAC Name:
- perhydroimidazo[4,5-d]imidazole-2,5-dione
- Test material form:
- solid: particulate/powder
1
- Specific details on test material used for the study:
- Batch number: Fixapret 140 Nr. 766.
Date of manufacturing: 24 March 2001.
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Test animals
Source: Harlan Winkelmann GmbH, Borchen, FRG.
Age at study Initiation: About 5 weeks.
Weight at study Initiation: 279 -366g.
Housing: Group Housed (5 to a cage).
Diet: Kuba Labordiät (Kaninchen Meerschweinchen-Hautungsdiät) Provimi Kuba SA, Kaiseraugst, Switzerland, ad libitum.
Water: Tap water, ad libitum.
Acclimatisation Period: 7 days befire the first test substance application.
Identification: Ear tattoo.
Environmental conditions
Temperature (°C): 20-24
Humidity (%): 30-70
Air Changes: None recorded but the room was fully air-conditioned.
Photoperiod (hrs dark/hrs light): 12/12.
Results and discussion
- Positive control results:
- In a concurrent 'positive control study' performed according to guidelines based on the Magnusson and Kligmann (1969), the sensitivity of Harlan Guinea pigs was assessed using the known sensitiser, α-hexylcinnamaldehyde (85%). As positive results were seen in the majority of the Guinea pig after 24 and 48 hours with little sign of decreasing it was deemed that α-hexylcinnamaldehyde (85%) has a positive sensitising effect on Guinea pig in the conditions chosen.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 5%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
The GPMT was run on 2 groups (each containing 5 Guinea pigs), the tests used a 25% concentration of the test substance and were appled to each test animal. When the patch was removed observations were recorded at both 24 and 48 hours of all 10 test animals however, no indication of sensitisation could be seen. The table recording this is seen below:
Right flank posterior: | Right flank posterior: | |||
Form of application: | Form of application: | |||
Test substance 25% in 1% Tylose in doubly distilled water | 1% Tylose in doubly distilled water | |||
Animal No. | Findings 24 hours after removal of patch | Findings 48 hours after removal of patch | Findings 24 hours after removal of patch | Findings 48 hours after removal of patch |
731 | 0 | 0 | 0 | 0 |
732 | 0 | 0 | 0 | 0 |
733 | 0 | 0 | 0 | 0 |
734 | 0 | 0 | 0 | 0 |
735 | 0 | 0 | 0 | 0 |
736 | 0 | 0 | 0 | 0 |
737 | 0 | 0 | 0 | 0 |
738 | 0 | 0 | 0 | 0 |
739 | 0 | 0 | 0 | 0 |
740 | 0 | 0 | 0 | 0 |
In addition to ensure the test conditions were valid, tests were conducted using both positive and negative controls. The posititive control group was tested with a known sensitising agent ( α-hexylcinnamaldehyde) also across 10 animals split into 2 groups. Across both viewings an average of 9 test animals showed signs of irritation. The test conditions can therefore, be assumed to be valid.
Similar to this on the other side of the test animal, a patch was used testing just the vehicle at the same concentration as with the test material. After 24 and 48 hours, this showed no signs of sensitisation. Therefore, the vehicle can be concluded to be a non-sensitiser under CLP Regulation (EC) 1272/2008.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study the test substance is not considered to be a sensitising agent.
- Executive summary:
The study was conducted under the guidelines of OECD 406 under GLP regulations to assess the sensitisation potential of perhydroimidazo[4,5 -6]imidazole-2,5 -dione in guinea pigs. The GPMT test was conducted by placing occlusive patches on the right hand side of each of the test animals. Each patch consisted of a 25% solultion of the test substance and a vehicle. In this case the vehicle was 1% Tylose in double distilled water. Each of the animals were then checked for any signs of distress or sensitisation after both 24 and 48 hours. This was the same procedure conducted on 10 different test animals. Across all these tests no signs of sensitisation occurred.
In addition the left side of each animal contained a semiocclusive patch treated with the test vehicle alone. This serves as a control group however, as with the test, no signs of sensitisation was noted. To ensure the test was valid a possitive control was also conducted. The positive control was a known sensitiser which was applied to 10 different test animals, kept and treated in the same conditions. During the 24 and 48 hour observations the positive control showed signs of sensitisation in 9/10 test animals. It can therefore be concluded the test method and conditions were valid. Therefore under the conditions of the study it is concluded that perhydroimidazo[4,5 -6]imidazole-2,5 -dione is a non-sensitising agent based on the criteria classification criteria under the CLP Regulation (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.