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EC number: 460-230-6 | 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: It was concluded that the test substance, EP-4000S, with a mean tissue viability of 56.4 ± 7.5%, was predicted as non-irritant to
the skin.
Eye irritation: The test substance, EP-4000S, elicited an In Vitro Irritancy Score of -0.4 ± 1.7 and was predicted to be a non-corrosive/ non-severe eye irritant.
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:
- 10 July 2012 - 28 August 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant study conducted in accordance with international guidelines.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Standard Operating Procedure, In Vitro Skin Irritation Test: Human Epidermis Model (L’Oreal 2009), supplied by L’Oreal (leading laboratory in the validation of the test for ECVAM).
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- other: EPISKIN three-dimensional human skin model.
- Details on test animals or test system and environmental conditions:
- The test involves the application of the test substance for 15 minutes to the EPISKIN three dimensional human skin model. The model consists of normal,
human-derived epidermal keratinocytes which have been seeded on a dermal substitute consisting of a collagen type 1 matrix coated with type IV collagen.
After 13 days in culture a multilayered, highly differentiated model of the human epidermis with a functional multi-layered stratum corneum
has formed. The epidermis surface area supplied is 0.38cm2.
The EPISKIN kits include
assay medium, maintenance medium, 12 well plates and the tissues which are shipped on nutritive agar. - Controls:
- other: Please refer to above entry
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 µL applied over each tissue using a positive displacement pipette - Duration of treatment / exposure:
- 15 ± 0.5 minutes
- Observation period:
- After 15 ± 0.5 minutes of exposure of the test substance, each tissue was rinsed and the inserts were blotted on absorbent paper to remove remaining sterile Dulbeccos Phosphate Buffered Saline (DPBS), rinsing agent. Each insert was then transferred to a well containing 2 mL maintenance medium and incubated for 42 ± 1 hour at 37°C ± 2 °C in a humidified atmosphere of 5% CO2 in air.
After 42 ± 1 hour, each insert was transferred to a well containing 2 mL of 0.3 mg/mL MTT and incubated for 3 hours ± 5 minutes at 37 ± 2°C in a humidified atmosphere of 5% CO2 in air. - Number of animals:
- The negative control was sterile Dulbecco’s Phosphate Buffered Saline (DPBS) with magnesium and calcium.
The positive control was 5% Sodium Dodecyl Sulphate (SDS) in distilled water. - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done):each tissue was rinsed with 25 mL sterile Dulbeccos Phosphate Buffered Saline (DPBS)
- Time after start of exposure: 15 ± 0.5 minutes - Irritation / corrosion parameter:
- other: other: Mean tissue viability
- Value:
- 56.4
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Remarks: Predicted as non-irritant. (migrated information)
- Irritant / corrosive response data:
- The test substance, EP-4000S/water solution and water control were colourless after the 15 minute shaking period. The test substance, EP-4000S, had not shown any potential for colouring water.
- Other effects:
- There was no change in the test substance, EP-4000S/MTT solution or the water control/MTT solution after three hours incubation in the dark at 37 ± 2°C in a humidified atmosphere of 5% CO2 in air. The test substance had not interacted with the MTT.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- It was concluded that the test substance, EP-4000S, with a mean tissue viability of 56.4 ± 7.5%, was predicted as non-irritant to the skin.
Reference
The results of the assay are summarised below:
Sample | Tissue viability as percentage of mean OD negative control | Prediction MTT endpoint | |||
Replicate Tissues |
Mean +/- SD | ||||
a | b | c | |||
Negative control | 102.1 | 98.0 | 99.9 | 100.0 ± 2.0 | Not applicable |
Positive control | 13.8 | 16.5 | 34.5 | 21.6 ± 11.3 | Irritant |
EP-4000S | 60.8 | 60.7 | 47.7 | 56.4 ± 7.5 | Non-irritant |
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:
- 14 August 2012- 15 August 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant study conducted in accordance with international guidelines.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- other: bovine eyes
- Details on test animals or tissues and environmental conditions:
- The bovine eyes were excised and collected as soon after slaughter as possible (excised at 12.30 hours, 14 August 2012).
Excised eyes were maintained and transported to the laboratory, at ambient temperature, in sufficient HBSS, containing 1% (v/v) penicillin/streptomycin solution, to cover all the eyes in the receptacle.
The eyes were used within 4 hours of slaughter. - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Concurrent positive and negative control corneas were examined
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 µL
- Concentration (if solution): neat - Duration of treatment / exposure:
- 10 minutes (± 30 seconds)
- Observation period (in vivo):
- Following incubation, the positive and negative controls were removed and the epithelial surface of the cornea washed, at least three times or until the wash medium (EMEM with phenol red) was clear and there was no discolouration. The wash medium was added via the holes on the top of the holder. After each wash, the wash medium was removed using a pipette tip attached to a vacuum pump.
As the test substance, EP-4000S, was very viscous, it was not possible to remove using the vacuum pump. The anterior glass was removed and the corneas were gently washed with EMEM without phenol red until there was no discolouration of the wash medium. The anterior glass was then replaced.
Following completion of the two hour incubation period, the medium was removed from both compartments and replaced with fresh cMEM. The posterior compartment was re-plugged and the opacity of each cornea measured and recorded.
The opacity values obtained at this stage were used in calculating the final In Vitro Irritancy Score.
Throughout the assay the corneas were examined for opaque spots or other irregularities. - Number of animals or in vitro replicates:
- Corneas were treated in triplicate with either the test substance, positive control (1% w/v sodium hydroxide) or negative control (0.9% sodium chloride solution).
- Details on study design:
- The assay uses isolated bovine corneas as a means of assessing the ocular corrosivity or severe irritancy potential of test substances in vitro.
The isolated corneas were obtained as a by-product of the meat production industry. Two endpoints, corneal opacity and permeability,
were measured and combined to give an In Vitro Irritancy Score. - Irritation parameter:
- other: Opacity
- Basis:
- mean
- Time point:
- other: 10 min
- Score:
- -0.333
- Remarks on result:
- other: SD=1.528
- Irritation parameter:
- other: Permeability OD 490
- Basis:
- mean
- Time point:
- other: 10min
- Score:
- -0.004
- Remarks on result:
- other: SD=0.013
- Irritation parameter:
- other: In Vitro Irritancy
- Basis:
- mean
- Time point:
- other: 10min
- Score:
- -0.4
- Remarks on result:
- other: In Vitro Irritancy Score (IVS) was calculated as: (Opacity +(15x Corrected OD 490)
- Irritant / corrosive response data:
- Throughout the assay the corneas were examined for opaque spots or other irregularities.
Following treatment with test substance, EP-4000S, the corneas were noted as clear. The corneas treated with the positive control, sodium hydroxide 1% (w/v), were very opaque and the corneas treated with the negative control, 0.9% saline, were clear. - Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance, EP-4000S, elicited an In Vitro Irritancy Score of -0.4 ± 1.7 and was predicted to be a non-corrosive/ non-severe eye irritant.
Reference
The positive control, sodium hydroxide (1%), elicited an In Vitro Irritancy Score of 131.4.
This value was within the historical range (mean ± 2 x SD = 82.3 – 144.7) for the assays performed to date.
The negative control, 0.9% saline, opacity mean change value was 1.0 which was below the maximum acceptance value of 2.0.
The permeability mean of the negative control was 0.028 which was below the maximum acceptance value of 0.1.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation/corrosion
The key skin irritation/corrosion study was performed with EP-4000S according to OECD guideline 439 and in accordance with GLP.
The test substance was applied to EPISKIN human epidermis skin constructs. The constructs consisted of normal, human-derived epidermal keratinocytes, which had been cultured to form a multilayered, highly differentiated model of the human epidermis with a functional multilayered stratum corneum. The cell viability was determined by mitochondrial dehydrogenase activity, assessed by the reduction of MTT (3-(4,5-dimethylthiazol-2-yl)-2, 5-diphenyltetrazolium bromide) to a soluble, coloured, formazan product. The prediction model uses the percentage viability values (compared to negative control viability) to identify
irritant and non-irritant substances.
The test substance, EP-4000S, elicited a mean tissue viability of 56.4 ± 7.5% and was predicted as non-irritant to the skin.
Eye irritation
The Bovine Corneal Opacity and Permeability Assay (BCOP) was performed to assess the ocular irritancy potential in vitro of the test substance, EP-4000S.The key eye irritation study was performed according to OECD guideline 437 and in accordance with GLP.
The assay uses isolated bovine corneas as a means of assessing the ocular corrosivity or severe irritancy potential of test substances in vitro. The isolated corneas were obtained as a by-product of the meat production industry. Two endpoints, corneal opacity and permeability, were measured and combined to give an In Vitro Irritancy Score which can be used to classify and rank test substances as potential eye irritants according to OECD guideline 437 (OECD 437).
The test substance, EP-4000S, elicited an In Vitro Irritancy Score of 56.4 ± 7.5 and was predicted to be a non-corrosive / non-severe eye irritant.
Justification for selection of skin irritation / corrosion endpoint:
GLP compliant study conducted in accordance with international guidelines.
Justification for selection of eye irritation endpoint:
GLP compliant study conducted in accordance with international guidelines.
Justification for classification or non-classification
In-vitro studies assessing skin irritation and eye irritation are available. Each study concluded that EP-4000S would not be irritant to skin or eyes; on this basis it is concluded that EP-4000S does not meet the criteria for classification as irritant under the CLP Regulation.
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