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EC number: 807-789-8 | CAS number: 111062-42-1
- 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
The registered substance is UN GHS Skin Irritation Category 2.
The registered substance is UN GHS Eye Irritation Category 2.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Study Initiation date: 18 May 18 Study conclusion date: 24 Sep 18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 2015
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Test Item name: Agent 447C
Purity: 40% Active in water, ~90% purity of active material - Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: All cells used are purchased or derived from tissue obtained by MatTek Corporation from accredited institutions
- Justification for test system used:
- Recommended test system in international guidelines (OECD)
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- Reconstructed Human Epidermis (RHE) tissue
- MatTek EpiDerm Tissue model EPI-200, Lot # 28614
-Keratinocyte Strain 00267 - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- amount applied: 30μI
- - Duration of treatment / exposure:
- 60 ± 1 minutes (25 minutes at room temperature and 35 minutes at 37°C, 5% CO2, ≥95% RH)
- Duration of post-treatment incubation (if applicable):
- 42 ± 4 hours post-treatment incubation
- Number of replicates:
- 3
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- 2.589
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- Other effects:
Colour interference with MTT: no - Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The test determined that a 40% solution of the registered substance reduced the viability to below 50% and is therefore an "irritant" according to OECD 439. OECD 439 cannot resolve between UN GHS Categories 1 and 2, further information on skin corrosion is required. Experience during manufacturing and use indicate that the registered product is not corrosive to the skin. Therefore, based on a weight of evidence with the consideration of the lack of corrosive effects during manufacture and use combined with the irritant result with OECD 439, the registered substance is a Skin Irritant Category 2.
- Executive summary:
The skin irritation potential of Agent 447C (a 40% solution of the registered substance) was assessed in vitro according to OECD 439. After 60 ± 1 minute exposure on the surface of the EpiDerm reconstructed human epidermis, and a 42 ± 4-hours post-exposure incubation time, viability of the tissues was assessed and compared to the negative control. The percentage of viability obtained was 2.589% and therefore Agent 447C (a 40% solution of the registered substance) was classified as irritant to the skin.
As OECD 439 cannot resolve between UN GHS Categories 1 and 2, further information on skin corrosion is required. Experience during manufacturing and use indicate that the registered product is not corrosive to the skin. Therefore, based on a weight of evidence with the consideration of the lack of corrosive effects during manufacture and use combined with the irritant result with OECD 439, the registered substance is a Skin Irritant Category 2.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (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:
- Study Initiation date: 04 April 18 Study conclusion date: 17 May 18
- 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)
- Version / remarks:
- 2017
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Test Item name: Agent 447C
Purity- 40% Active in Water, ~90% purity of active material - Species:
- human
- Details on test animals or tissues and environmental conditions:
- TEST ITEM:
EpiOcular™ (OCL-200) Reconstructed Human Ocular Epithelium
Lot # 27036
Keratinocyte Strain 4F1188 - Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 20 μI of PBS (sterile Dulbecco's Phosphate Buffered Saline) + 50 μI of test item
- Duration of treatment / exposure:
- 30 minutes ± 2 minutes
- Duration of post- treatment incubation (in vitro):
- 2 hours ± 15 minutes
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Details of materials, reagents and equipment used are recorded in the study data.
Positive control -Methyl Acetate
Negative control - Sterile Water (tissue grade) - Irritation parameter:
- cornea opacity score
- Run / experiment:
- Mean
- Value:
- 0.061
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Remarks:
- Mean of viability
- Value:
- 2.838
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The test determined that a 40% solution of the registered substance reduced the viability to below 60% and therefore “no prediction” regarding the irritation or corrosive potential of the substance can be determined according to OECD 492. OECD 492 cannot resolve between UN GHS Categories 1 and 2, further information on eye corrosion is required. Experience during manufacturing and use indicate that the registered product is not corrosive to the eye. Therefore, based on a weight of evidence with the consideration of the lack of corrosive effects during manufacture and use combined with the irritant result with OECD 492, the registered substance is a Eye Irritant Category 2.
- Executive summary:
The eye irritation potential of Agent 447C (a 40% solution of the registered substance) was assessed in vitro according to OECD 492. After 30 ± 2 minutes exposure on the surface of the EpiOcular reconstructed ocular epithelium, and a 2 hour ± 15 minutes post-incubation time, viability of the tissues was assessed and compared to the negative control. The percentage of viability obtained was 2.838% and no prediction can be made for Agent 447C (a 40% solution of the registered substance) as further information is required to distinguish between corrosive and irritating.
In vitro testing with OECD 492 has not allowed for a prediction of eye irritation of Agent 447C (a 40% solution of the registered substance). As OECD 492 cannot resolve between UN GHS Categories 1 and 2, further information on eye corrosion is required. Experience during manufacturing and use indicate that the registered product is not corrosive to the eye. Therefore, based on a weight of evidence with the consideration of the lack of corrosive effects during manufacture and use combined with the “no prediction” result with OECD 492, the registered substance is a Eye Irritant Category 2.
Reference
Prior to the study, the required preliminary test confirmed that the test item did not interfere with MTT or solvent.
% of viability: 2.838 - Classification = No prediction.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The skin irritation potential of Agent 447C (a 40% solution of the registered substance) was assessed in vitro according to OECD 439. After 60 ± 1 minute exposure on the surface of the EpiDerm reconstructed human epidermis, and a 42 ± 4-hours post-exposure incubation time, viability of the tissues was assessed and compared to the negative control. The percentage of viability obtained was 2.589% and therefore Agent 447C (a 40% solution of the registered substance) was classified as irritant to the skin.
As OECD 439 cannot resolve between UN GHS Categories 1 and 2, further information on skin corrosion is required. Experience during manufacturing and use indicate that the registered product is not corrosive to the skin. Therefore, based on a weight of evidence with the consideration of the lack of corrosive effects during manufacture and use combined with the irritant result with OECD 439, the registered substance is a Skin Irritant Category 2.
The eye irritation potential of Agent 447C (a 40% solution of the registered substance) was assessed in vitro according to OECD 492. After 30 ± 2 minutes exposure on the surface of the EpiOcular reconstructed ocular epithelium, and a 2 hour ± 15 minutes post-incubation time, viability of the tissues was assessed and compared to the negative control. The percentage of viability obtained was 2.838% and no prediction can be made for Agent 447C (a 40% solution of the registered substance) as further information is required to distinguish between corrosive and irritating.
In vitro testing with OECD 492 has not allowed for a prediction of eye irritation of Agent 447C (a 40% solution of the registered substance). As OECD 492 cannot resolve between UN GHS Categories 1 and 2, further information on eye corrosion is required. Experience during manufacturing and use indicate that the registered product is not corrosive to the eye. Therefore, based on a weight of evidence with the consideration of the lack of corrosive effects during manufacture and use combined with the “no prediction” result with OECD 492, the registered substance is a Eye Irritant Category 2.
Justification for classification or non-classification
In vitro testing with OECD 439 and 492 has identified Agent 447C (a 40% solution of the registered substance) as irritant to the skin and eye; respectively. As OECD 439 and 492 cannot resolve between UN GHS Categories 1 and 2, further information on skin and eye corrosion is required. Experience during manufacturing and use indicate that the registered product is not corrosive to the skin or eye. Therefore, based on a weight of evidence with the consideration of the lack of corrosive effects during manufacture and use combined with the irritant result with OECD 439 and 492, the registered substance is a Skin Irritant Category 2 and Eye Irritant Category 2.
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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