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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
A in-vitro study on skin irritation/corrosion according to OECD guideline 439 (EPISKIN) revealed no irritation following a 15 minutes exposure period. An in-vitro study on eye irritation according to OECD guideline 437 (BCOP) revealed
no severe eye irritating or corrosive properties.
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:
- 18 May 2011 - 15 November 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 439
- Deviations:
- no
- Principles of method if other than guideline:
- The objective of this study was to assess the skin irritation potential, in vitro, of the test substance. The test was conducted in accordance with the 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) and the OECD 439 Guideline For The Testing of Chemicals: In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method (OECD439).
- GLP compliance:
- yes (incl. QA statement)
- Species:
- other:
- Strain:
- other:
- Controls:
- not required
- Amount / concentration applied:
- The positive and negative controls were in liquid form and were applied by dispensing a volume of 10 μl over each tissue using a positive displacement pipette. A weight of 10 ±2 mg of the test substance, LZ1554, a highly viscous brownish liquid, was applied to the tissue using the curved edge of a spatula. In order to spread 10 ±2 mg, a higher amount of 12 ±2 mg was weighed to compensate for some of the substance sticking to the spatula.
- Duration of treatment / exposure:
- After incubation of at least 24 hours in maintenance medium, triplicate tissues were dosed for 15 minutes with the test substance, negative or positive control at room temperature. A maximum of four samples were applied in a block with a minimum of 1 minute intervals between each application of substance. On application of 10 μl, the positive control was spread over the tissue for approximately 30 seconds and then respread with a curved flat spatula after approximately 7 minutes application time.
After 15 minutes, each tissue was rinsed with 25 ml sterile Dulbeccos Phosphate Buffered Saline (DPBS) to remove residual test substance. The surface of the tissues treated with the test substance, LZ1554, were also gently swabbed to remove residual test material. Inserts were then blotted on absorbent paper to remove remaining DPBS. Each insert was then transferred to a well containing 2 ml maintenance medium and incubated for 42 ± 1 hour at 37 ± 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. - Observation period:
- At the end of 3 hours ± 5 minutes, the triplicate inserts were blotted on absorbent paper. The epidermis was removed from the insert using a biopsy punch, the epidermis separated from the collagen matrix using forceps and both parts placed in a micro tube. When all tissues had been punched, the tissues were vortexed with 500 El of acidic isopropanol (0.04 N HCl final concentration).
The tissues were extracted by storing at 2-8 ºC, protected from light, for 70 hours. - Number of animals:
- No animals were used as the method carried out was an in-vitro method.
- Irritation / corrosion parameter:
- other: other: tissue viabiity
- Value:
- 107.8
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 42 hours. Max. score: 111.9. (migrated information)
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- It was concluded that the test substance, LZ1554, with a mean tissue viability of 107.8 ± 5.4%, was predicted as non-irritant to the skin.
- Executive summary:
The skin irritation/corrosion potential was determined in a GLP-compliant study in accordance with OECD guideline no. 439 (EPISKIN method). It was concluded that the test substance, LZ1554, with a mean tissue viability of 107.8 ± 5.4%, was predicted as non-irritant to the skin.
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
- Study period:
- 08 February 2011 - 29 July 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 437
- Deviations:
- no
- Principles of method if other than guideline:
- The Bovine Corneal Opacity & Permeability Assay (BCOP) which was developed by Pierre Gautheron 1992 as an in vitro alternative to the in vivo Draize Eye Irritation test. The assay uses isolated bovine corneas as a means of assessing the ocular irritancy potential of test substances in vitro.
- GLP compliance:
- yes (incl. QA statement)
- Details on test animals or tissues and environmental conditions:
- Test animals are not used in this In-Vitro study.
- Amount / concentration applied:
- Corneas were treated in triplicate with either the test substance, positive control (10% w/v sodium hydroxide) or negative control (0.9% sodium chloride solution).
- Duration of treatment / exposure:
- The test material or controls were in contact with the cornea for a total of 10 minutes (± 30 seconds). Each holder was incubated in a horizontal position at 32°C ± 1°C in a waterbath.
- Observation period (in vivo):
- 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.
- Number of animals or in vitro replicates:
- No animals used as method carried out was an in-vitro method.
- Irritation parameter:
- in vitro irritation score
- Value:
- 0.5
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The test substance, LZ1554, elicited an In Vitro Irritancy Score of 0.5 ± 1.9 and was predicted to be a non corrosive/ non severe eye irritant.
- Executive summary:
The eye irritation potential was determined in a GLP-compliant study in accordance with OECD no. 437 (BCOP method). The test substance, LZ1554, elicited an In Vitro Irritancy Score of 0.5 ± 1.9 and was predicted to be a non corrosive/ non severe eye irritant.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the data available the substance is not classified or labeled according to Directive 67/548/EEC (DSD) or Regulation 1272/2008/EC (CLP).
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.