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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 610-130-5 | CAS number: 436083-99-7
- 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: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- amporphous glass fibre formed from the melting and fiberisation of predominately slilcon dioxide, calcium oxide, magnesium oxide
- EC Number:
- 610-130-5
- Cas Number:
- 436083-99-7
- Molecular formula:
- Amorphous glass consisting of SinO(3n-1)2(n-1) Polymeric anions ionically bonded to Ca2+ and Mg2+ cations or other alkaline earth cations
- IUPAC Name:
- amporphous glass fibre formed from the melting and fiberisation of predominately slilcon dioxide, calcium oxide, magnesium oxide
- Details on test material:
- - Name of test material (as cited in study report): Isofrax, Carbawool(sic)
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Remarks:
- CBA/CaCrl strain mice
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd.
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 9 to 10 weeks old
- Weight at study initiation: 18 to 23 g
- Housing: The animals were housed in groups of up to five during acclimatisation and housed in pairs from Day 1. Bedding was provided on a weekly basis to each cage by use of clean European softwood bedding.
- Diet (e.g. ad libitum): 5LF2 EU Rodent Diet 14%, was freely available to the animals at all times. Each batch of diet had been analysed for specific constituents and contaminants by the manufacturer.
- Water (e.g. ad libitum): Mains water was provided, ad libitum, via cage-mounted water bottles.
- Acclimation period: At least 7 days
- Indication of any skin lesions: None noted
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 40 to 70%. On one occasion the minimum humidity was 34%. As this deviation was minimal and only occurred for a short length of time it was considered not to have affected the overall interpretation of study findings, nor compromised the integrity of the study.
- Air changes (per hr): At least 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
Study design: in vivo (LLNA)
- Vehicle:
- propylene glycol
- Concentration:
- 10, 25 and 50% w/v
- No. of animals per dose:
- 4 females per dose
- Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility: The vehicle was chosen because it was the first of the vehicles listed in the protocol that produced an overtly stable solution, emulsion or dispersion incorporating 50% w/v of the test article.
- Irritation: None noted.
- Systemic toxicity: Death or signs of systemic toxicity were not noted.
- Ear thickness measurements: No major changes noted
- Erythema scores: No erythema was observed.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response: The test article is regarded as a sensitiser when the maximum value of the SI is 3.0 or above. The test article is classified as a non-sensitiser when the maximum value of the SI is less than 3.0. (This result is unchanged by observations of irritation at sites of application of the test formulation).
TREATMENT PREPARATION AND ADMINISTRATION: Formulations were freshly prepared as required using propylene glycol on Days 1, 2 and 3. The formulations were stored at room temperature, in sealed, air-tight containers prior to dosing and were used within two hours of preparation. The formulations were mixed by multiple inversion of the containers prior to administration to ensure homogeneity. Concentrations of test article were expressed gravimetrically and in terms of test article received (without regard to purity or active content).
Each mouse was manually restrained with both auditory pinnae left free. The outer aspect of both pinnae of each mouse was treated by direct application of the appropriate vehicle control or test formulation (0.025 mL/pinna) dispensed from an automatic micro pipette. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- No statistical analysis required
Results and discussion
- Positive control results:
- The sensitivity and reliability of the test system has been checked using α hexylcinnamaldehyde (CAS Number 101 86 0). A Stimulation Index of 3.0 or greater is expected from this substance. An SI of 5.54 was obtained in the latest positive control test (10 Feb 2021) at 25% in AOO (vehicle mean DPM 1276 and test group DPM 7073) indicating acceptability.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 1.32
- Test group / Remarks:
- 10% w/v
- Parameter:
- SI
- Value:
- 1.15
- Test group / Remarks:
- 25% w/v
- Parameter:
- SI
- Value:
- 1.54
- Test group / Remarks:
- 50% w/v
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA
DETAILS ON STIMULATION INDEX CALCULATION: The scintillation counter provided data including the DPM value (disintegrations per minute during a ten minute period). The DPM value for each test group was divided by the DPM for the control group to provide the Stimulation Index (SI) value for each test group.
EC3 CALCULATION: As the SI index was less than 3, no EC3 value could be calculated.
CLINICAL OBSERVATIONS: There were no clinical signs indicative of a systemic effect of treatment among mice treated with the vehicle or with 10, 25 or 50% w/v formulations of the test article. The vehicle and test formulation application sites remained free of irritation.
BODY WEIGHTS: There was no indication of a treatment related effect on body weight.
SIGNS OF TOXICITY (including dermal irritation at the site of administration, if any, e.g. increased ear thickness): None noted
Any other information on results incl. tables
Table: Group DPM and SI
Concentration (%w/v) in Propylene glycol | Group number | Group DPM | Simulation Index (SI) |
Vehicle | 1 | 172 | NA |
10 | 2 | 227 | 1.32 |
25 | 3 | 198 | 1.15 |
50 | 4 | 265 | 1.54 |
Applicant's summary and conclusion
- Conclusions:
- None of the Stimulation Index values crossed the threshold level to be considered a positive indicator and there was no evidence of a dose response relationship, therefore the Local Lymph Node Assay demonstrated that the substance does not have the potential to cause skin sensitisation under the conditions of the study.
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.