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Diss Factsheets
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EC number: 944-533-5 | 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
Endpoint summary
Administrative data
Description of key information
Skin irritation/corrosion: Not irritating
(OECD 439, GLP, K, rel. 1).
Eye irritation: Irritating, top-down approach:
- ICE: no prediction can be made (OECD 438, GLP, WoE, rel.1)
- EpiOcular: potentially requiring classification and labelling according to the EU CLP (Category 1 or 2) (OECD 492, GLP, WoE, rel.1)
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation:
Since no key study was identified on the registered substance, the testing and assessment strategy, as described in ECHA R.7a Endpoint specific guidance (December 2016), was used to evaluate the skin corrosion/irritation potential of the registered substance:
|
Element |
Information |
Conclusion |
Comments |
Existing data on physico |
1a |
Is the substance spontaneously flammable in contact with air (pyrophoric) or water at room temperature? |
NO |
|
1b |
Is the substance an organic hydroperoxide or an organic peroxide? |
NO |
|
|
1c |
Is the pH of the substance ≤ 2.0 or ≥ 11.5? |
NO |
|
|
1d |
Are there other physical or chemical properties that |
NO |
|
|
Existing human data |
2 |
Are there adequate existing human data which provide evidence that the substance is a corrosive |
NO |
|
Existing animal data from corrosion/irritation studies |
3 |
Are there data from existing studies on corrosion and irritation in laboratory animals, which provide sound conclusive evidence that the substance is a corrosive, irritant or non-irritant? |
NO |
|
Existing data from general toxicity studies via the dermal route and from sensitisation studies |
4a |
Is the substance classified as fatal in contact with skin (LD50 ≤ 50 mg/kg bw, CLP hazard statement |
NO |
|
4b |
Has the substance proven to be a corrosive, irritant or non-irritant in a suitable acute dermal toxicity test? |
NO |
|
|
4c |
Has the substance proven to be a corrosive or an irritant in sensitisation studies or after repeated |
NO |
|
|
Existing/new (Q)SAR data and read |
5a |
Are there structurally related substances (suitable “read-across” or grouping), which are classified as corrosive to the skin (Skin Corrosive Cat. 1), or do suitable (Q)SAR methods indicate corrosion |
NO |
Not applicable - UVCB substance |
5b |
Are there structurally related substances (suitable “read-across” or grouping), which are classified as irritant to the skin (Skin Irritant Cat. 2), or indicating that the substance is non-irritant, or do suitable (Q)SAR methods indicate irritant or non-irritant potential of the substance? |
NO |
|
|
Existing in vitro data |
6a |
Has the substance demonstrated corrosive properties in an EU/OECD adopted in vitro test? |
NO |
|
6b |
Has the substance demonstrated irritant or non-irritant properties in an EU/OECD adopted in vitro test? |
NO |
(at the initiation of the dossier, no test was available) |
|
6c |
Are there data from a non-validated suitable in vitro test(s), which provide sound conclusive evidence that the substance is corrosive/ irritant? |
NO |
|
|
Weight-of- Evidence analysis |
7 |
The “elements” described above may be arranged as appropriate. Taking all available existing and |
NO |
|
New in vitro test for corrosivity |
8 |
Does the substance demonstrate corrosive properties in (an) EU/OECD adopted in vitro test(s) for skin corrosion? |
NO |
|
New in vitro test for irritation |
9 |
Does the substance demonstrate irritating or non-irritating properties in (an) EU/OECD adopted in vitro test(s) for skin irritation? |
YES |
=> an Episkin test for irritation was initiated (Bottom-up strategy - substance expected to be non corrosive). The conclusion of this Episkin test is sufficient to conclude on C&L (viability = 103.1 % <=> Not a skin irritant) |
New in vivo test for corrosion/irritation |
10 |
To be used only as a last resort |
NO |
In vivo testing should not be conducted in this case since the substance falls under the scope of the specific in vitro tests performed, and there are no substance-specific limitations on use of those tests. An adaptation according to Annex XI to the REACH Regulation is included in this dossier. |
The in vitro skin irritation study (Envigo, 2016, Rel.1) was performed according to the OECD Guideline 439 and in compliance with GLP, using the EPISKIN reconstructed human epidermis model. The quality criteria required for acceptance of results in the test were satisfied. The relative mean viability of the test item treated tissues was 103.1 %, after the 15‑minute exposure period. With a tissue viability > 50%, the test material was considered to be non-irritant to skin.
Eye irritation:
Since no key study was identified on the registered substance, the testing and assessment strategy, as described in ECHA R.7a Endpoint specific guidance (December 2016), was used to evaluate the eye damage/irritation potential of the registered substance:
|
Element |
Information |
Conclusion |
Comments |
Conclusion of the information strategy on skin corrosion/irritation |
0 |
Is the substance classified as a skin corrosive? |
NO |
|
Existing data on physico |
1a |
Is the substance spontaneously flammable in contact with air (pyrophoric) or water at room temperature? |
NO |
|
1b |
Is the substance an organic hydroperoxide or an organic peroxide? |
NO |
|
|
1c |
Is the pH of the substance ≤ 2.0 or ≥ 11.5? |
NO |
|
|
1d |
Are there other physical or chemical properties that indicate that the substance causes serious eye damage or eye irritation? |
NO |
|
|
Existing human data |
2 |
Are there adequate existing human data which provide evidence that the substance has the potential to cause serious eye damage or eye irritation? |
NO |
|
Existing animal data from corrosion/irritation studies |
3 |
Are there data from existing studies on corrosion and irritation in laboratory animals, which provide sound conclusive evidence that the substance is a corrosive, irritant or non-irritant? |
NO |
|
Existing/new (Q)SAR data and read-across |
4 |
Are there structurally related substances (suitable “read-across” or grouping), which are classified as causing serious eye damage/eye irritation, or indicating that the substance is non-irritant, or do valid (Q)SAR methods indicate serious eye damage/eye irritation or non-irritation of the substance? |
NO |
Not applicable - UVCB substance |
Existing in vitro data |
5a |
Has the substance demonstrated serious eye damage, eye irritation or non-irritating properties in an EU/OECD adopted in vitro test? |
NO |
|
5b |
Are there acceptable data from (a) non-validated suitable in vitro test(s), which provide sound evidence that the substance causes serious eye damage/eye irritation? |
NO |
(at the initiation of the dossier, no test was available) |
|
Weight-of- Evidence analysis |
6 |
The “elements” described above may be arranged as appropriate. Taking all available existing and relevant data mentioned above (Elements 0 – 5) into account, is there sufficient information to make a decision on whether classification/labelling is necessary, and – if so – how to classify and label? |
NO |
|
New in vitro tests for serious eye damage/eye irritation (Annex VII to the REACH Regulation) |
7a |
Does the substance demonstrate serious eye damage, eye irritation or non-irritant properties in (an) EU/OECD adopted in vitro test(s) for the eye hazard charaterisation? |
NO |
|
8b |
Does the substance demonstrate serious eye damage or eye irritant properties in (a) non-validated suitable in vitro test(s) for serious eye damage/eye irritation? |
NO |
=> an ICE assay was initiated: no prediction can be made |
|
New in vivo test for serious eye damage/eye irritation as a last resort (Annex VIII to the REACH Regulation) |
8b |
Does the substance demonstrate serious eye damage or eye irritation in an OECD adopted in vivo test? |
NO |
In vivo testing should not be conducted in this case since the substance is submitted at Annex VII level to the REACH regulation |
An ICE assay (Envigo, 2016, Rel.1) was conducted according to the OECD guideline No. 438 and in compliance with GLP. The ocular reactions observed in eyes treated with the test item were:
- maximal mean score of corneal opacity: 1.0, corresponding to the ICE class II;
- mean score of fluorescein retention: 0.5, corresponding to the ICE class I;
- maximal mean corneal swelling: 14.69% corresponding to the ICE class III.
Therefore no prediction can be made according to the combination of the three endpoints. As a consequence, further in vitro testing was conducted following the top-down approach (Scott et al., 2010) to conclude on eye irritation classification.
The EpiOcular test (Envigo, 2017, Rel.1) was conducted according to the OECD guideline No. 492 and in compliance with GLP. The quality criteria required for acceptance of results in the test were satisfied. The tissue viability of the test item was 9.8% after the 6 -hour exposure period. With a percentage of tissue viability < 60%, the test item require classification for eye irritation or eye damage.
Following the top-down approach, taking into account the ICE assay (not eye damage), the EpiOcular assay (not non-classified) and the absence of skin irritation; the substance is considered to be an eye irritant (Scott et al. 2010).
Reference:
Scott L, Eskes C, Hoffmann S, Adriaens E, Alepée N, Bufo M, Clothier R, Facchini D, Faller C, Guest R, Harbell J, Hartung T, Kamp H, Varlet BL, Meloni M, McNamee P, Osborne R, Pape W, Pfannenbecker U, Prinsen M, Seaman C, Spielmann H, Stokes W, Trouba K, Berghe CV, Goethem FV, Vassallo M, Vinardell P and Zuang V (2010) A proposed eye irritation testing strategy to reduce and replace in vivo studies using Bottom-Up and Top-Down approaches. Toxicol In Vitro 24:1-9.
Justification for classification or non-classification
Harmonized classification:
The substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.
Self-classification:
Based on the available information, the substance should be classified as eye irritant Category 2 (H319: Causes serious eye irritation) according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP).
No additional self-classification is proposed regarding skin irritation according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP).
No data was available regarding respiratory 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.
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