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Diss Factsheets
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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015-01-13 to 2015-01-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented study performed according to OECD 437 guideline, in compliance with GLP. No deviations were recorded.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- 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)
Test material
- Test material form:
- liquid: viscous
- Details on test material:
- - Name of test material (as cited in study report): XTA 823- Substance type: yellow slightly viscous liquid- Physical state: liquid- Purity: UVCB (reaction product of tetraethylene pentamine and maleic anhydride 30-60%)- Purity test date: no data- Lot/batch No.: BLW0010057- Expiration date of the lot/batch: 2015-12-01- Stability under test conditions: no data- Storage condition of test material: at approximately 4°C in the dark
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES- Source:bovine eyes from adult cattle were obtained from a local abattoir as a by-product from freshly slaughtered animals- Number of animals: no data- Characteristics of donor animals (e.g. age, sex, weight): adult cattle typically 12 to 60 months old- Storage, temperature and transport conditions of ocular tissue (e.g. transport time, transport media and temperature, and other conditions):The eyes were excised by an abattoir employee after slaughter and placed in Hanks' Balanced Salt Solution (HBSS) supplemented with antibiotics (penicillin at 100 IU/ml and streptomycin at 100 µg/ml). They were transported to the test facility over ice packs on the same day of slaughter. The corneas were prepared immediately on arrival.- Time interval prior to initiating testing:- indication of any existing defects or lesions in ocular tissue samples: no- Indication of any antibiotics used: noPREPARATION OF CORNEAS- All eyes were macroscopically examined before and after dissection. Only corneas free of damage were used. - The cornea from each of selected eye was removed leaving a 2 to 3 mm rim of sclera to facilitate handling. The iris and lens were peeled away from the cornea. The isolated corneas were immersed (epithelial side uppermost) in a dish containing HBSS until the were mounted in Bovine Corneal Opacity and Permeability (BCOP) holders.- The anterior and posterior chambers of each BCOP holder were filled with complete Eagle's minimum essential medium (MEM) and plugged. The holders were incubated at 32 +/- 1°C for 60 minutes. At the end of the incubation period each cornea was examined for defects. Only corneas free of damage were used.PRE-TREATMENT OPACITY READING- A pre-treatment opacity reading was taken for each cornea using a calibrated opacitometer. The average opacity for all corneas was calculated.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.75 ml, used as suppliedNEGATIVE CONTROL: 0.9% w/v sodium chloride solution- Amount(s) applied (volume or weight with unit): 0.75 ml- Lot/batch no. (if required): 301038501- Purity: 0.9%- Expiry date: 2015-09-01- Storage conditions: at room temperaturePOSITIVE CONTROL: ethanol- Amount(s) applied (volume or weight with unit): 0.75 ml- Lot/batch no. (if required): STBD7546V- Purity: >99.8%- Expiry date: 2015-08-11- Storage conditions: at room temperature
- Duration of treatment / exposure:
- 10 minutes
- Duration of post- treatment incubation (in vitro):
- 220 minutes
- Number of animals or in vitro replicates:
- 3 eyes/group; 3 groups
- Details on study design:
- REMOVAL OF TEST SUBSTANCE- Washing (if done): at the end of the exposure period the test item and control items were removed from the anterior chamber and the cornea was rinsed 3 times with fresh complete minimum essential medium (MEM) containing phenol red before a final rinse with complete MEM. The anterior chamber was refilled with fresh complete MEM.- Time after start of exposure: 10 minutes- After a post-treatment opacity reading and visual observation of each cornea the holders were incubated at 32 +/- 1°C for 120 minutes. After incubation the holders were removed from the incubator and a final opacity reading was taken. Each cornea was visually observed.APPLICATION OF SODIUM FLUORESCEIN- Following the opacity measurement the permeability of the corneas to sodium fluorescein was evaluated. The medium from the anterior chamber was removed and replaced with 1 ml of sodium fluorescein solution (4 mg/ml). The dosing holes were plugged and the holders incubated, anterior chamber uppermost, at 32 +/- 1°C for 90 minutes.PERMEABILITY DETERMINATIONS- After incubation the medium in the posterior chamber of each holder was decanted and retained.- 360 µl of medium representing each cornea was applied to a designated well on a 96-well plate and the optical density at 492 mm (OD492) was measured using the Anthos 2001 microplate reader.SCORING SYSTEM:- The In Vitro Irritancy Score was calculated using the following formula:In Vitro Irritancy Score = mean opacity value + (15 x mean OD492 value)- Additionally, the opacity and permeability values were evaluated independently to determine wether the test item induced a response through only one of the two endpoints. - The test item was classified according to the prediction model below:IVIS Classification<=3 No category. Not requiring classification to UN GHS or EU CLP>3; <=55 No prediction of eye irritation can be made>55 Category 1. UN GHS or EU CLP causes serious eye damage
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- test item
- Value:
- 0.9
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- negative control
- Value:
- 3.4
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- positive control
- Value:
- 40.9
- Other effects / acceptance of results:
- OTHER EFFECTS:- Visible damage on test system: Corneal epithelium condition: the corneas treated with the test item were clear post treatment and post incubation. The corneas treated with te negative control item were clear post treatment and post incubation. The corneas treated with the positive control item were cloudy post treatment and post incubation.DEMONSTRATION OF TECHNICAL PROFICIENCY: no dataACCEPTANCE OF RESULTS: - Acceptance criteria met for negative control: negative control gave opacity of <=4.7 and permeability <=0.080. The negative control acceptance criteria were therefore satisfied- Acceptance criteria met for positive control: positive control IVIS was within the range of 27.8-51.0. The positive control acceptance criterion was therefore satisfied- Range of historical values if different from the ones specified in the test guideline: no data
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results (IVIS score < 3), the test substance is considered not irritant to eyes and should not be classified for 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.
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