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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: - | 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 (OECD 404, OECD 439): not irritating
eye irritation (OECD 405; OECD 437): not irritating
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:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin
The skin irritation potential of the test substance was determined by an in vitro skin irritation test using a human skin model and by a primary skin irritation/corrosion study in the rabbit.
The skin irritation potential of the test substance was determined by an in vitro skin irritation test using a human skin model according to OECD Guideline 439 and in compliance with GLP (Andres, 2014). In average, 24.9 mg test substance was applied topically to moistened (DPBS buffer) human skin tissues (EpiDermTM) with a tissue size of 0.63 cm2 for 60 min. After a 42 ± 2 h post-incubation period, the cytotoxic (irritancy) effect was assessed. Cell viability is measured by dehydrogenase conversion of MTT, present in cell mitochondria, into a blue formazan salt, that is quantitatively measured after extraction from tissues. DPBS buffer was used as negative control, 5% SDS solution was used as positive control. The relative mean tissue viability obtained after 60 min treatment with the test substance compared to the negative control tissues was 101.8%. Since the mean relative tissue viability for the test substance was above 50% after 60 min treatment the test substance is considered to be non-irritant. The optical density of the negative control was well within the required acceptability criterion of 0.8 ≤ mean OD ≤ 2.8. The positive control 5% sodium dodecyl sulphate solution revealed a mean cell viability of 2.2% (required ≤ 20%) after 60 min exposure and thus ensuring the validity of the test system. Variation within replicates was acceptable. Based on the results, the test substance was not irritating to the skin under the conditions of the test.
In a primary skin/corrosion study according to OECD Guideline 404 and in compliance with GLP 0.5 g test substance moistened with 50% (v/v) ethanol-water was applied sequentially to the clipped skin of 3 male New Zealand White rabbits under semi-occlusive conditions for 4 h (Latour, 2015). Scoring of skin reactions (erythema and edema) was performed 1, 24, 48 and 72 h after removal of the patch. No skin irritation was caused by 4 hours exposure to the test substance and no staining of the treated skin by the test substance was observed. Furthermore, no test substance remnants were seen and no signs of systemic toxicity were observed in the animals during the test period and no mortality occurred. Based on the results, the test substance was not irritating to the skin under the conditions of the test.
In conclusion, the test substance is non-irritant in the in vitro skin irritation test and in the in vivo primary skin/corrosion study in rabbits under the experimental conditions used.
Eye
The eye irritation potential of the test substance was determined by a bovine corneal opacity and permeability test (BCOP test) and by an acute eye irritation study in the rabbit.
The eye irritation potential of the test substance was determined in a bovine corneal opacity and permeability test (BCOP test) according to OECD Guideline 437 and in compliance with GLP (Andres, 2014). The solid test substance was applied directly to the epithelial surface of three cattle corneas for 4 h ± 5 min at 32 ± 1 °C. After exposure the corneas were washed and opacity values were measured. In addition the permeability of the corneas was measured with a photometer after incubation of the corneas with sodium fluorescein solution for 90 min. The results of the opacity and permeability measurement of the test substance were used to calculate an in vitro irritation score (IVIS) of - 0.585. The negative control showed no irritation effects and no serious eye damage, mean IVIS was 1.333. The mean in vitro irritation score of the positive control (20% (w/v) imidazole) was 118.485. All three values for negative and two values for positive controls were within the range of historical data of the test facility. Therefore, the test system was acceptable. The value of the positive control, which lay outside of the historical data, can be seen as uncritical, because the value showed a clear positive result. Based on the results, the test substance was not irritating to the eye under the conditions of the test.
In an acute eye irritation study according to OECD Guideline 405 and in compliance with GLP samples of 21.4 mg test substance (corresponds to a volume of approx. 0.1 mL) were instilled into one eye of each of 3 male New Zealand White rabbits (Latour, 2015). Eye reactions were scored 1, 24, 48 and 72 h after instillation. Instillation of the test substance resulted in irritation of the conjunctivae, which consisted of redness, chemosis and discharge. The irritation had completely resolved within 24 hours in two animals and within 48 hours in the other animal. No iridial irritation or corneal opacity were observed. Remnants of the test substance were present on the outside of the eyelids of all animals on Day 1. The overall mean irritation score over 24, 48 and 72 h for chemosis, iris and corneal effects was 0. The irritation score over 24, 48 and 72 h for conjunctival redness was 0 in two animals and 0.3 in one animal. No signs of systemic toxicity were observed in the animals during the test period and no mortality occurred. Based on the results, the test substance was not irritating to the eyes under the conditions of the test.
In conclusion, the test substance is non-irritant in the in vitro eye irritation test and in the in vivo acute eye irritation study in rabbits under the experimental conditions used.
Justification for selection of skin irritation / corrosion endpoint:
No study was selected since the in vitro and the in vivo guideline study were adequate and reliable.
Justification for selection of eye irritation endpoint:
No study was selected since the in vitro and the in vivo guideline study were adequate and reliable.
Justification for classification or non-classification
The available data on skin and eye irritation of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.
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.