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EC number: 280-445-7 | CAS number: 83411-71-6
- 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 skin irritant
Eye irritant
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/corrosion
A primary dermal irritation study is available. In this study performed similarly to the OECD guideline No. 404, 6 male New Zealand White rabbits, were dermally exposed to 0.5 ml of undiluted test substance.
Prior to the topical application, the skin of the rabbit was prepared with an electric clipper to remove the hair. After clipping, the left side of the animal was prepared by making epidermal abrasions, while the right site remained intact (clipped but unabraded). The test substance was then applied on the skin (abraded or not) on two different application sites (site 1 and 2). Then the test sites were covered with an occlusive dressing for 24 hours. Those exposure conditions correspond to a worst case approach as the test guidance recommends an exposure under semi-occlusive patch and for 4h. Skin irritation was assessed and scored according to the Draize scale at 24 and 72 hrs after the topical application of the test patch. The mean individual scores calculated within 2 scoring times (24 and 72 hrs) for the unabraded skin were 0.5/0.5/0.5/1.0/1.0/1.0 for erythema and 1.5/1.0/1.0/1.0/1.5/1.5 for edema. Therefore the registered substance is considered as slightly irritating to the rabbit skin.
Severe skin irritation was observed in one of the two acute dermal toxicity studies. However, worst case conditions were used such as an occlusive patch, a 24h exposure period and a large amount of test substance (approximately 10 times higher than the volume required in a specific skin irritation study (5 ml vs 0.5 ml). Such severe conditions could explain the observed skin irritation in the dermal acute toxicity tests.
Eye irritation
Two studies were available and both studies were of the same Klimisch validity, but the study considered as the key study in a worst case approach as the results of the study permit to classify the substance as irritating to eyes. In this study performed similarly to the OECD No. 405 guideline and in compliance with the GLP, 0.1 ml of undiluted test material was instilled into the conjunctival sac of left eye of male Albino New Zealand Rabbits. After the instillation the substance was not remained for 6 animals while for the three others the treated eye was washed with water 20 to 30 seconds after the instillation. Animals were then observed for 7 days for eye edema and erythema of the conjunctive, corneal opacity and iris lesion. Eye irritation was assessed and scored according to the Draize scale at 24, 48 and 72 hrs after the instillation of the substance and then at days 4 and 7. The mean individual score were calculated within 3 scoring times (24, 48 and 72 hrs).For the animals whose eye was not rinsed, the mean individual scores were 1.7/2.3/1.7/2.0/2.0/3.3 for chemosis, 1.3/2.0/1.7/1.7/1.0/2.0 for conjunctival erythema, and 0.7/0.7/0.7/0.7/1.7/2.0 for corneal opacity. All of these effects were not totally reversible within the termination of the study (7 days) in all animals. Indeed, cornea opacity was still observed by day 7 in 2 animals, redness and chemosis of the conjunctivae were still observed in 3 animals. However there is a tendency to reversibility. In addition, there was no effect on the iris of all unirrigated animals. For the animals, whose eye was washed after the instillation, slight and transient effects of the conjunctivae were observed within the first 3 days after the instillation.
Justification for classification or non-classification
Based on the available data (erythema and edema scores are lower than 2.3), the test substance is not classified for skin irritation according to the criteria indicated in the CLP Regulation (EC) No 1272/2008.
Based on the chemosis scores (≥2) obseved in 4 out of 6 animals in the key study, the substance is classified in Category 2 for Eye irritation (H319) according to the CLP Regulation (EC) No.1272/2008.
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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