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Diss Factsheets
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EC number: 604-314-4 | CAS number: 142844-00-6
- 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
Testing for skin irritation has proved negative.Due to the nature of the substance it is scientifically and ethically unjustified to perform an eye irritation study.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Remarks:
- Negative results in skin irritation studies in animals and no positive results in humans result in non classification for irritancy and corrosion.In accordance with 31st Adaptation to Technical Progress (ATP) of Directive 67/548/ECC
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Chopped fibre in water
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival limited Moston Sandbach Cheshire
- Age at study initiation:12-16 weeks
- Weight at study initiation:234-253 kg
- Housing: Individually housed in suspended metal cages
- Diet (e.g. ad libitum):Spillers rabbit diet
- Water (e.g. ad libitum):mains drinking water
- Acclimation period:5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):18-22
- Humidity (%):52-57
- Air changes (per hr):approx 15
- Photoperiod (hrs dark / hrs light):12hour cycle - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- 0.5g/rabbit
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- Chopped fibre applied on to the shorn skin and held in place with a semi occlusive dressing. The site examined at 1,24,48,72 hours
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1 hr
- Score:
- ca. 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- no irritation or corrosion observed
- Other effects:
- none
- Interpretation of results:
- other:
- Remarks:
- Negative results in skin irritation studies in animals and no positive results in humans result in non classification for irritancy and corrosion.In accordance with 31st Adaptation to Technical Progress (ATP) of Directive 67/548/ECC
- Conclusions:
- The test article could not be classified as irritant
- Executive summary:
There is no reason to classify this material as irritant nor corrosive.
This was confirmed with 31st Adaptation to Technical Progress (ATP) of Directive 67/548/ECC as published 15th January 2009 as the classification as “irritant” was removed for all types of man made vitreous fibres (MMVFs). .
Reference
Table 1 - RCF : Acute Dermal irritation test in rabbit - individual daily and individual mean scores for dermal irritation following 4 hour exposure
Skin Reaction |
Reading (hours) |
Individual scores – rabbit number and sex (body weight kg) |
||
191 female (2.28) |
199 male (2.46) |
201 male (2.89) |
||
Erythema/Eschar formation |
24 48 72 |
0 0 0 |
1 0 0 |
0 0 0 |
Total |
|
0 |
1 |
0 |
Mean Score |
|
0.0 |
0.3 |
0.0 |
Oedema formation |
24 48 72 |
0 0 0 |
0 0 0 |
0 0 0 |
Total |
|
0 |
0 |
0 |
Mean Score |
|
0.0 |
0.0 |
0.0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- GLP compliance:
- yes
- Species:
- human
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Reconstructed human like epithelium
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 50mg solid
- Duration of treatment / exposure:
- 6hours+/- 15 mins
- Duration of post- treatment incubation (in vitro):
- 18hours+/- 15 mins
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- - Details of the test procedure used
- RhCE tissue construct used, including batch number
- Doses of test chemical and control substances used
- Duration and temperature of exposure, post-exposure immersion and post-exposure incubation periods (where applicable)
- Description of any modifications to the test procedure
- Indication of controls used for direct MTT-reducers and/or colouring test chemicals (if applicable)
- Number of tissue replicates used per test chemical and controls (positive control, negative control, NSMTT, NSCliving and NSCkilled, if applicable)
- Wavelength and band pass (if applicable) used for quantifying MTT formazan, and linearity range of measuring device (e.g. spectrophotometer)
- Description of the method used to quantify MTT formazan
- Description of the qualification of the HPLC/UPLC-spectrophotometry system (if applicable)
- Description of evaluation criteria used including the justification for the selection of the cut-off point for the prediction model
- Reference to historical positive and negative control results demonstrating suitable run acceptance criteria
- Complete supporting information for the specific RhCE tissue construct used
- Reference to historical data of the RhCE tissue construct
- Demonstration of proficiency in performing the test method before routine use by testing of the proficiency chemicals
- Positive and negative control means and acceptance ranges based on historical data
- Acceptable variability between tissue replicates for positive and negative controls
- Acceptable variability between tissue replicates for the test chemical - Irritation parameter:
- in vitro irritation score
- Run / experiment:
- expected
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- other: Classed as non irritating
- Conclusions:
- substance is confirmed to be not irritatiing and as such is not classified as an irritant
- Executive summary:
Substance was confirmed as non irritating
Reference
Ocular irritation prediction
According to OECD guidelines and GHS classification, an irritant is predicted if the mean relative tissue viability of two individual tisues exposed to the test substance is <=60% of the mean viability of the negative controls.
In vitro result |
GHS Classification |
Mean tissue viability less than or equal to 60% |
Category 1 or 2 |
Mean tissue viability greater than 60% |
No category |
The summarised results and irritation classification are as follows:
Test and Control Article identity |
Tissue Viability |
Irritancy classification |
GHS Classification |
|
Mean |
Diff. |
|||
Refractory ceramic fibre (RCF) - Aluminosilicate wool |
105.4% |
5.38% |
Non-irritant |
No Category |
Tissue Culture water (negative control) |
100.0% |
2.67% |
Non-irritant |
No Category |
Methyl acetate (positive control) |
36.0% |
6.03% |
Irritant |
Category 1 or 2 |
Diff = difference between the tissues
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Although negative results have only been obtained for skin, inhalation exposures using the nose only route produce simultaneous heavy exposures to the eyes and there are no reports of excess eye irritation . Animals exposed by inhalation similarly show no evidence of respiratory tract irritation. Human data has confirmed that only mechanical irritation occurs in humans resulting in itching of the skin. Screening at manufacturers’ plants in the UK has not revealed any cases of skin conditions in workers related to fibre exposure. The study report is detailed in section 7.10.1 |
Justification for classification or non-classification
Negative results in skin irritation studies in animals and no positive results in humans result in non classification for irritancy and corrosion.In accordance with 31st Adaptation to Technical Progress (ATP) of Directive 67/548/ECC as published 15th January 2009 the classification as “irritant” has been removed for all types of man made vitreous fibres (MMVFs).
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.
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