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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 917-830-2 | CAS number: 1186514-91-9
- 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
Non-irritating in an in vitro EpiDerm(R) OECD 439 study, and non-irritating in an ex vivo BCOP OECD 437 study.
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Guideline study under GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes (incl. QA statement)
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: Human derived transformed keratinocytes.
- Cell source:
- other: EpiDerm(R)
- Details on animal used as source of test system:
- Origin:
EpiDerm(TM) tissues were procured from MatTek In Vitro Life Science Laboratories, Bratislava.
Designation of the kit: EPI-200-SIT
Day of delivery: 08. Mar. 2016
Batch no.: 23320 - Justification for test system used:
- validated test system
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- Specification:
Commercially available EpiDerm (TM)-Kit.
The EpiDerm(TM) tissue consists of human-derived epidermal keratinocytes which have been cultured to form a multi-layered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. The EpiDerm(TM) tissues are cultured on specially prepared cell culture inserts. - Control samples:
- yes, concurrent positive control
- other: Dulbecco PBS
- Amount/concentration applied:
- The test item was applied directly to each tissue and spread to match the tissue size (0.63 cm2)
- Duration of treatment / exposure:
- 60 minutes
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- main
- Value:
- >= 105.3 - <= 106.2
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Remarks:
- Results given as % of negative control
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: no
- Direct-MTT reduction: tested and found to be inactive
- Colour interference with MTT: tested and found to be inactive
DEMONSTRATION OF TECHNICAL PROFICIENCY:
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
- Acceptance criteria met for variability between replicate measurements: yes
- Range of historical values if different from the ones specified in the test guideline: within range - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Skin irritation of the test substance was tested in vitro using the EpiDerm (R) system in OECD 439 guideline under GLP. No decrease in cell viability was observed, as measured by MTT reduction to formazan. The substance is not classified as a skin irritant.
Reference
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Guideline study under GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- other: cattle
- Strain:
- other: Bos primigenius Taurus
- Details on test animals or tissues and environmental conditions:
- Bovine corneas were obtained from slaughtered cattle which were bettween 12 and 60 months old.
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount / concentration applied:
- 750 ml applied directly on the entire surface of the cornea
- Duration of treatment / exposure:
- 10 minutes
- Duration of post- treatment incubation (in vitro):
- 2 hour incubation, then washed, and incubated for an additional 90 min.
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS: examined and only corneas which were free from damages were used. The corneas were excised with a scalpel and cut from the globe with a 2-3 mm ring of sclera around the outside. Each cornea was transferred to a cornea holder in which pre-warmed cMEM (32 ± 1 °C) without phenol red was filled. The holders were then incubated for 1 h in the incubation chamber at 32 ± 1 °C.
QUALITY CHECK OF THE ISOLATED CORNEAS: performed and checked for tissue damage.
NUMBER OF REPLICATES: 3
NEGATIVE CONTROL USED: 0.9% sodium chloride
SOLVENT CONTROL USED (if applicable)
POSITIVE CONTROL USED: DMF
APPLICATION DOSE AND EXPOSURE TIME: see above
TREATMENT METHOD: closed chamber
POST-INCUBATION PERIOD: yes. If YES please specify duration: see above
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: 1 set of multiple rinses, using cMEM without phenol red
- POST-EXPOSURE INCUBATION: yes, 90 min
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: measured by placing the cornea in a spectral photometer and recording the absorbance at 570 nm.
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of [UV/VIS spectrophotometry / microtiter plate reader] (OD490): yes
-
SCORING SYSTEM: In Vitro Irritancy Score (IVIS), see above
DECISION CRITERIA: please specify if the decision criteria as indicated in the TG was used. yes - Irritation parameter:
- in vitro irritation score
- Run / experiment:
- mean
- Value:
- 0.41
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- The test substance caused no effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 0.41. All controls were valid and within historical control ranges.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item showed no effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 0.41. As the value is below 3, the substance is not an eye irritant.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The test item showed no effects on viability of human epidermal cells (EpiDerm(R)) detected through the MTT assay, with viability at 105% of negative control values.
The test item showed no effects on the cornea of the bovine eye, with a calculated IVIS (in vitro irritancy score) is 0.41. As the value is below 3, the substance is not an eye irritant.
Justification for classification or non-classification
According to the OECD 439 Guideline, substances which result in a decrease in skin cell viability of 50% are considered skin irritants. The viability of test substance was not decreased, but was slightly higher than negative control values. According to the OECD 437 Guideline, an in vitro irritancy score (IVIS) of less than or equal to 3 is evidence that the test substance is not an eye irritant. As the IVIS for the substance is 0.41, the criterion for classification is not met. The substance is not classified for skin or eye 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.
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.