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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 931-597-4 | 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation, other
- Remarks:
- other: Chorioallantoic membrane test method (HET-CAM)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Study was conducted on 31 May 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: the general requirements of French Official Text, Annex IV, dated on December 26th, 1996
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Invitox protocol No. 47 dated on January 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: NIH publication No. 06-4515 (March 2006)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 4 December 2006
Test material
- Reference substance name:
- The product from the burning of a combination of carbonaceous materials.
- EC Number:
- 931-597-4
- Molecular formula:
- UVCB substance, not available. View remarks field.
- IUPAC Name:
- The product from the burning of a combination of carbonaceous materials.
- Details on test material:
- - Name of test material: Mixed ash
- Physical state: powder
- Composition range of test material (% (w/w)): Aluminium (Al) 13.07, Calcium (Ca) 45.52 , Iron (Fe) 4.15 , Magnesium (Mg) 3.49, Phosphorus (P) 0.79 , Potassium (K) 2.56, Silicon (Si) 28.07, Sodium (Na) 1.08, Sulphur (S) 1.27.
- The critical minor components examined (mg/kg d.w.): Arsenic (As) 18, Barium (Ba) 670 Cadmium (Cd) 3.6, Copper (Cu) 410, Lead (Pb) 180 and Antimony (Sb) 22.
- Purity test date: the substance is UVCB substance
- Lot/batch No.: MIXED ASH 1-01032010
- Expiration date of the lot/batch: March 2011
- Stability under test conditions: Stable
- Storage condition of test material: Room temperature
- Other: Mixed Ash is named in dossier as Ash. Mixed in the substance name has meant that there have been several (mixed) fuels when producing ash.
Constituent 1
Test animals / tissue source
- Species:
- other: fertile chicken eggs
- Strain:
- other: Isa Brown
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Couvoir d'Ile de France, ZI Equillemont, 3 rue Helene Boucher, 28700 Auneau
- Age at study initiation: 10 days after fertilization and incubation
- Weight at study initiation: Between 53.3 and 64.4 g on the first day of the study
- Housing: Eggs were delivered few days after fertilization. Observations were performed at the time of delivery of the eggs. Eggs were directly placed into a specified incubator at 37.8°C ± 1°C until the start of the experiment (D10). The incubator was provided with manual rotation. Eggs were rotated twice a day.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 37.8°C ± 1°C
- Humidity (%): 43 - 62%
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL, MIXED ASH
- Amount(s) applied (volume or weight with unit): 0.3 ml of grounded test material
- Concentration (if solution): undiluted
POSITIVE CONTROL ITEM
A 0.1N sodium hydroxide solution (SIGMA-Aldrich, Batch 017K6098, Expiry date: Feb 2014) was used as positive control item.
NEGATIVE CONTROL ITEM
A 0.9% sodium chloride solution (Cooper, Batch 19BM05GA, Expiry date: Dec 2013) was used as a negative control item. - Duration of treatment / exposure:
- 20 seconds
- Observation period (in vivo):
- 5 minutes
- Number of animals or in vitro replicates:
- 12 eggs: 4 eggs for each treatment group. See Table 1.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): With 0.9% sodium hydrochloride solution
- Time after start of exposure: 20 s
SCORING SYSTEM: Scores were calculated according to HET-CAM scoring system Table 2
TOOL USED TO ASSESS SCORE: Halogen candling light, Super Flash
Results and discussion
In vivo
Results
- Irritation parameter:
- other: Haemorrhage and coagulation
- Basis:
- mean
- Time point:
- other: 30 - 120 s
- Score:
- ca. 12
- Max. score:
- 21
- Reversibility:
- not specified
- Remarks on result:
- other: See Tables 4-6.
- Irritant / corrosive response data:
- See Tables 4-6.
Any other information on results incl. tables
Irritation score and irritation score mean
In the negative control, 4/4 eggs showed no hyperemia, no hemorrhage and no coagulation at the end of the 5-minute observed period. In the positive control, 4/4 eggs showed an hemorrhage within the first 30 seconds and coagulation before the end of the first 2 minutes of observation. For instance, the negative and positive controls induced a response that falls within the classification of non-irritating (ISmean=0) and severely irritating (ISmean=14) respectively. For this reason, the test is considered valid.
All eggs treated with test item MIXED ASH showed haemorrhage and coagulation between 30 and 120 seconds of observation period. Mean irritation score calculated after treatment with test item MIXED ASH was 12. The results are summarised in the Table 4.
Table 4 Mean irritation score and irritation category
Treatment | Cotation (IS Mean) | Irritation category |
Negative control (NaCl 0.9%) | 0 | Non irritant |
Positive control (NaOH 0.1N) | 14 | Severe irritation |
MIXED ASH | 12 | Severe irritation |
Individual and mean results are presented in Table 5 and 6.
Table 5 Irritation Score Mean (mean values)
Treatment | IS | |
Negative control | Mean | 0 |
SEM | 0 | |
N | 4 | |
Positive control | Mean | 14 |
SEM | 0 | |
N | 4 | |
MIXED ASH | Mean | 12 |
SEM | 0 | |
N | 4 |
No statistical analysis. IS: Irritation score calculated for each eggs as follows: IS = score obtained for hyperemia + score obtained for haemorrhage + score obtained for coagulation
Table 6 Appearance time of hyperemia, hemorrhage and coagulation. Results are expressed in second (s)
Treatment | Egg number | Time of hyperemia (s) | Time of hemorrhage (s) | Time of coagulation (s) |
Negative control | 20100001 | Not appeared | Not appeared | Not appeared |
20100002 | Not appeared | Not appeared | Not appeared | |
20100003 | Not appeared | Not appeared | Not appeared | |
20100004 | Not appeared | Not appeared | Not appeared | |
Positive control | 20100005 | Not appeared | 14 | 43 |
20100006 | Not appeared | 15 | 36 | |
20100007 | Not appeared | 15 | 37 | |
20100008 | Not appeared | 12 | 34 | |
MIXED ASH | 20100009 | Not appeared | 35 | 80 |
20100010 | Not appeared | 46 | 65 | |
20100011 | Not appeared | 60 | 66 | |
20100012 | Not appeared | 42 | 75 |
Applicant's summary and conclusion
- Interpretation of results:
- highly irritating
- Remarks:
- severe irritant Criteria used for interpretation of results: EU
- Conclusions:
- Ash was found to be severe irritant.
- Executive summary:
Eye irritation properties of Ash were determined in a GLP compliant laboratory with an in vitro Hen's Egg Test Chorioallantoic Membrane (HET-CAM) test. The test method used is based on the general requirements of French Official Text, Annex IV, dated on December 26th, 1996, Invitox protocol No. 47 dated on January 1992 and NIH publication No. 06-4515 (March 2006). After 10-day incubation of fertilised eggs, 0.3 ml of pulverised Ash was placed onto the CAM for 20 second. The CAMs were observed for a period of 5 min by using candling light. The observed reactions were haemorrhage and coagulation of the CAM. Thus, Ash is severe irritant for the eye.
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.