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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 Jan 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- 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)
- Version / remarks:
- adopted in Oct 2017
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Version / remarks:
- adopted in Feb 2017
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesamt für Umwelt, Mainz, Germany
Test material
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: Müller Fleisch GmbH, Birkenfeld, Germany
- Characteristics of donor animals: The cattles were between 12 and 60 months old.
- Storage, temperature and transport conditions of ocular tissue: The eyes were transported to the test facility in Hanks’ Balanced Salt Solution with 1% Penicillin-Streptomycin solution (Penicillin 100 U/mL, Streptomycin 100 µg/mL) in a suitable cooled container within 1 h.
- Time interval prior to initiating testing: The corneas were isolated on the same day after delivery of the eyes.
- Indication of any existing defects or lesions in ocular tissue samples: After the arrival of the corneas, they were examined and only corneas which were free from damages were used.
- Indication of any antibiotics used: 1% Penicillin-Streptomycin solution (Penicillin 100 U/mL, Streptomycin 100 µg/mL)
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 750 µL
NEGATIVE CONTROL
- Amount(s) applied: 750 µL
POSITIVE CONTROL
- Amount(s) applied: 750 µL - Duration of treatment / exposure:
- 10 min
- Duration of post- treatment incubation (in vitro):
- 2 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
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 complete Minimum Essential Medium (MEM, 32 ± 1 °C) without phenol red was filled. The holders were then incubated for 1 h in the incubation chamber at 32 ± 1 °C.
TREATMENT METHOD: closed chamber
POST-INCUBATION PERIOD: yes, 2 h
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: Thorough rinsing with complete MEM with phenol red and final rinsing with complete MEM without phenol red.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: The change of opacity value of each treated cornea with test item, positive control and negative control was calculated by subtracting the initial basal opacity from the post treatment opacity reading for each cornea.
- Corneal permeability: Passage of sodium fluorescein dye measured with the aid of a microtiter plate reader (OD492). The corrected OD492 value of each cornea treated with test item and positive control was calculated by subtracting the mean negative control cornea value from the original permeability value for each cornea.
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA
Test substance with an IVIS > 55 was regarded as severe irritant/corrosive and labelled Category 1.
Test substance with an IVIS ≤ 3 was regarded as non-irritant and labelled in no category.
Test substance with an IVIS > 3; ≤ 55: no prediction can be made.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- mean value of 3 corneae
- Value:
- 0.44
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- With the negative control (Hank’s Balanced Salt Solution) neither an increase of opacity nor permeability of the corneas could be observed (mean IVIS = 1.30).
The positive control (dimethylformamide) was tested undiluted and showed clear opacity and distinctive permeability of the corneas (mean IVIS = 110.48) corresponding to a classification as serious eye damaging (CLP/GHS (Cat 1)).
Relative to the negative control, the test item did not cause an increase of the corneal opacity or permeability. The calculated mean IVIS was 0.44 (threshold for serious eye damage: IVIS > 55).
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The values of mean opacity (0.63) and mean permeability (0.01) were within the range of historical data of the test facility (range of opacity: -1.17 – 2.63; range of permeability: -0.01 – 0.06).
- Acceptance criteria met for positive control: IVIS of the positive control was 110.48 and thus within the range of historical data of the test facility (IVIS: 36.23 - 150.41).
Any other information on results incl. tables
Table 1: Optical density at 492 nm of Negative Control, Test Item and Positive Control
Parameter | Negative Control | Test Item | Positive Control | ||||||
1. Replicate | 2. Replicate | 3. Replicate | 1. Replicate | 2. Replicate | 3. Replicate | 1. Replicate | 2. Replicate | 3. Replicate | |
1. Measurement | 0.061 | 0.050 | 0.036 | 0.055 | 0.046 | 0.066 | 1.367 | 0.630 | 0.852 |
2. Measurement | 0.061 | 0.048 | 0.031 | 0.054 | 0.044 | 0.066 | 1.411 | 0.647 | 0.881 |
3. Measurement | 0.057 | 0.051 | 0.036 | 0.055 | 0.044 | 0.066 | 1.390 | 0.648 | 0.871 |
1. Measurement – blank | 0.0243 | 0.0133 | -0.0007 | 0.0183 | 0.0093 | 0.0293 | 13.303 | 0.5933 | 0.8153 |
2. Measurement – blank | 0.0243 | 0.0113 | -0.0057 | 0.0173 | 0.0073 | 0.0293 | 13.743 | 0.6103 | 0.8443 |
3. Measurement – blank | 0.0203 | 0.0143 | -0.0007 | 0.0183 | 0.0073 | 0.0293 | 13.533 | 0.6113 | 0.8343 |
Mean of each replicate | 0.0230 | 0.0130 | -0.0023 | 0.0180 | 0.0080 | 0.0293 | 13.527 | 0.6050 | 0.8313 |
Mean of the 3 replicates | 0.0112 | -- | -- | ||||||
Corrected | -- | -- | -- | 0.0068 | -0.0032 | 0.0181 | 13.414 | 0.5938 | 0.8201 |
Corrected mean of the 3 replicates | -- | 0.0072 | 0.9184 |
Table 2: IVIS Values
Test Group | IVIS | Mean IVIS | Relative Standard Deviation IVIS |
Negative Control | 1.52 | 1.30 | 14.60% |
1.17 | |||
1.21 | |||
Test Item | 0.26 | 0.44 | 115.04% |
1.01 | |||
0.04 | |||
Positive Control | 133.11 | 110.48 | 21.85% |
113.27 | |||
85.07 |
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
- Conclusions:
- Under the conditions of this test, the test item did not cause an increase of the corneal opacity or permeability. The calculated mean in vitro irritancy score was 0.44 in the in vitro Bovine Corneal Opacity and Permeability Test. Therefore, the test substance does not require classification for eye irritation or serious eye damage.
CLP: not classified
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)
Hoewel ECHA veel materiaa in uw taal online heeft, is een deel van deze pagina in het Engels. Meer informatie van ECHA over meertaligheid.
Welkom op de ECHA-website. In Internet Explorer 7 (en vroegere versies) wordt deze site niet volledig ondersteund. U schakelt het best op een recentere versie van Internet Explorer over.
Deze website maakt gebruik van cookies om het surfen zo aangenaam mogelijk te maken.
Lees meer over hoe wij cookies gebruiken.