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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 226-408-0 | CAS number: 5395-50-6
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- 24h occlusive exposure to intact and abraded rabbit skin, with 7-day observation period
- GLP compliance:
- no
- Remarks:
- pre-GLP study
Test material
- Reference substance name:
- Tetrahydro-1,3,4,6-tetrakis(hydroxymethyl)imidazo[4,5-d]imidazole-2,5(1H,3H)-dione
- EC Number:
- 226-408-0
- EC Name:
- Tetrahydro-1,3,4,6-tetrakis(hydroxymethyl)imidazo[4,5-d]imidazole-2,5(1H,3H)-dione
- Cas Number:
- 5395-50-6
- Molecular formula:
- C8H14N4O6
- IUPAC Name:
- 1,3,4,6-tetrakis(hydroxymethyl)-octahydro-[1,3]diazolo[4,5-d]imidazole-2,5-dione
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Test substance no.: 78/15-1
- physical state: liquid
Test animals
- Species:
- rabbit
- Strain:
- other: Albino
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: about 3 - 4 kg
- Housing: single
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: > 7 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 55 ± 10%
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 ml
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 24 h
- Observation period:
- After 24 h and 72 h, and additional reading after 7 d in the case of findings after 72 h
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: About 2.5 cm x 2.5 cm = about 6.25 cm²
- Type of wrap used: Covering of the material applied to the skin sites with gauze (2 layers 2.5 cm x 2.5 cm). Fixing of the gauze with an elastic bandage. Additionally, the trunk was wrapped in a PVC sheet.
REMOVAL OF TEST SUBSTANCE
- no
OBSERVATION TIME POINTS
- After 24 h and 72 h, and additional reading after 7 d in the case of findings after 72 h
SCORING SYSTEM: Scale for scoring the irritation index based on DRAIZE:
1 . Erythema and eschar formation:
No erythema 0
Very slight erythema (barely perceptible) 1
WeII-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4
Total possible erythema score 4
2. Edema formation:
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area weil defined by definite raising) 2
Moderate edema (raised approximately 1 mm) 3
Severe edema (raised more than 1 mm and extending beyond the area of exposure) 4
Total possible edema score 4
IRRITATION INDEX: ∑[(1)+(2)] / N
ASSESSMENT OF THE IRRITATION INDEX
0 to 0.5 non irritating
0.6 to 3.0 slightly irritating
3.1 to 5.0 moderately irritating
5.1 to 8.0 severely irritating
OTHER EXAMINATIONS
- Sacrifice of the rabbits: 7 d after application, assessment of the subcutaneous connective tissue and the muscles underneath at the application site
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24h/72h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: scabs observed in 3 animals
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24h/72h
- Score:
- 0.17
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- see section "Any other information on results incl. tables"
- Other effects:
- - Other adverse local effects: 24 h after application, the intact skin was blue colored in one rabbit. A slight induration of the abraded skin was detected in one other rabbit. The intact and abraded skin was sunken in places in one additional rabbit.
7 d after application, scabbing was observed on the abraded skin in all rabbits and also on the intact skin of 3 rabbits.
- Necropsy findings: Intact skin: In one rabbit, vessels in the subcutaneous connective tissue definitely injected; muscles without any abnormalities
Abraded skin: In two rabbits, vessels in the subcutaneous connective tissue definitely injected; muscles without any abnormalities
Any other information on results incl. tables
Individual results of skin irritation study on rabbits
Readings | Time after appl. (h) | Skin irritation index Rabbit No. |
Total value (∑) | Mean (x) | |||||
1 | 2 | 3 | 4 | 5 | 6 | ||||
1. Erythema/ Eschar Formation | |||||||||
Intact skin | 24 | 0 | 3 | 1 | 2 | 3 | 1 | 10 | 1.67 |
72 | 0 | 2 | 1 | 2 | 3 | 0 | 8 | 1.33 | |
Abraded skin |
24 | 2 | 3 | 3 | 4 | 3 | 1 | 16 | 2.67 |
72 | 1 | 2 | 3 | 3 | 3 | 1 | 13 | 2.17 | |
2. Edema |
|||||||||
Intact skin |
24 | 0 | 2 | 0 | 0 | 0 | 0 | 2 | 0.33 |
72 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Abraded skin |
24 | 0 | 0 | 0 | 1 | 2 | 1 | 4 | 0.67 |
72 | 1 | 0 | 0 | 1 | 2 | 0 | 4 | 0.67 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not considered to be classified for irritation, because the GHS criteria are not met. The mean values of erythema as well as edema are below the value of 1.5, which is the range limit of category 3, for 3 out of the 6 animals. The remaining 3 animals showed erythema with mean values (24 h and 72 h) between 2 and 3.
3 of 6 animals showed formation of crusts 7 d after application. Although there was no later observation time point it can be assumed that these effects would have been reversible within an additional week. - Executive summary:
In this pre-GLP skin irritation study on rabbits the test substance was applied undiluted to the clipped skin (intact and abraded) of 6 rabbits. Untreated skin sites served as negative control. An occlusive coverage was used and the exposure period was 24 h. After 24 h and 72 h the effects were assessed and scaled based on Draize. An additional reading was made after 7 d in the case of findings after 72 h. The mean values of erythema as well as edema are below the value of 1.5, which is the range limit of category 3, for 3 out of the 6 animals. The remaining 3 animals showed erythema with mean values (24 h and 72 h) between 2 and 3. Thus the GHS criteria are not met and therefore the test substance is not considered to be classified for irritation.
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.