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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 269-142-0 | CAS number: 68188-14-7
- 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:
- weight of evidence
- Study period:
- Mar - Apr 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- ADAPTATION ACCORDING TO REACH ANNEX XI, section 1 - See attached justification for WoE: Eye irritation
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
- Reference Type:
- other: Amendment No. 1 to the study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- 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:
- 09 Oct 2017
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Resin acids and Rosin acids, barium salts
- EC Number:
- 269-142-0
- EC Name:
- Resin acids and Rosin acids, barium salts
- Cas Number:
- 68188-14-7
- Molecular formula:
- N/A
- IUPAC Name:
- Resin acids and Rosin acids, barium salts
- Test material form:
- solid
- Details on test material:
- Specific details on test material used for the study
SOURCE OF TEST MATERIAL
- Batch number of test material: EXP NR.3757-01
- Expiration date of the lot/batch: 31 Dec 2029
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: refrigerator
- Stability under storage conditions: The stability of the test substance under storage conditions is
guaranteed until 31 Dec 2029 as indicated by the sponsor, and the sponsor holds this responsibility.
- Stability under test conditions: no data
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source: BASF SE Ludwigshafen, Germany
- lot/batch number of test material: EXP NR.3757-01
- Expiration date of the lot/batch: 31 Dec 2029
- Purity: 100 % UVCB
- Physical state: Solid
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Refrigerator
- Stability under storage conditions: was guaranteed over the study period
Test animals / tissue source
- Species:
- cattle
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Freshly slaughtered cattles, Schlachthof Alzey, Emil Färber GmbH & Co. KG, Robert-Bosch-Strasse 23, 55232 Alzey, Germany
- Characteristics of donor animals (age): minimum 12 months, maximum 60 months
- indication of any existing defects or lesions in ocular tissue samples: Corneas free of defects (opacity, scratches, pigmentation etc.)
Test system
- Vehicle:
- water
- Remarks:
- Deionized
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL, NC AND PC
- Amount(s) applied (volume or weight with unit): 750 µL
- Concentration (if solution): 20% test material / Imidazole (w/v) suspension in deionized water - Duration of treatment / exposure:
- 4 hours
- Number of animals or in vitro replicates:
- Each treatment group (test substance, NC and PC) consisted of 3 corneas
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
:
Corneas free of defects (opacity, scratches, pigmentation etc.) were dissected with a
2 to 3 mm rim of sclera. Isolated corneas were mounted in cornea holders that consist of anterior and posterior chambers. Both chambers were filled to excess with pre-warmed Eagles’s MEM (without phenol red) and then equilibrated in a vertical position at about 32°C for at least 1 hour. After the equilibration period the medium in both chambers was replaced with fresh pre-warmed medium, and initial corneal opacity readings were taken for each cornea with an opacitometer.
QUALITY CHECK OF THE ISOLATED CORNEAS :
Any corneas that showed macroscopic tissue damage or an opacity value < 553 opacity units2 were discarded. The remaining corneas were then distributed into negative control, positive control and treatment groups.
NUMBER OF REPLICATES : 3
NEGATIVE CONTROL USED : yes
POSITIVE CONTROL USED : yes
APPLICATION DOSE AND EXPOSURE TIME : 750µL, 4 hours
TREATMENT METHOD: open chamber
POST-INCUBATION PERIOD: no
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: 3
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: yes,
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of UV/VIS spectrophotometry (OD490)
- Others (pertinent visual observations): Before measurement, each cornea was observed visually and observations were recorded. Final corneal opacity readings were taken for each cornea with an opacitometer.
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: according to the OECD Guideline 437 (adopted 09 Oct 2017) for evaluation of results.
- IVIS ≤ 3: NO Category
- IVIS > 3; ≤ 55: No prediction can be made
- IVIS > 55 : Category 1
- IVIS 1,5 - 4,5: "borderline" result
- IVIS 45 - 65: "borderline" result
A “borderline“ evaluation was determined statistically using historic BASF data and takes the test facility-specific variance of the test method into account. This evaluation is an amendment to the evaluation provided in OECD Guideline 437.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 1
- Value:
- 8.1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: No indication of corrosion
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: no
DEMONSTRATION OF TECHNICAL PROFICIENCY: yes
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
Any other information on results incl. tables
Table 1: In Vitro Irritancy score (IVIS) of the test substance, the NC
and the PC
Test substance identification |
Cornea- No. |
Opacity per cornea |
Permeability per cornea |
per cornea |
IVIS per group |
|
mean |
SD |
|||||
|
7 |
0.0 |
0.191 |
2.9 |
|
|
19/0421-1 |
8 |
0.0 |
0.462 |
6.9 |
8.1 |
5.8 |
|
9 |
8.1 |
0.420 |
14.4 |
|
|
|
1 |
9.3 |
0.003 |
9.3 |
|
|
NC |
2 |
3.4 |
0.005 |
3.5 |
6.8 |
3.0 |
|
3 |
7.5 |
0.008 |
7.6 |
|
|
|
4 |
84.7 |
1.451 |
106.4 |
|
|
PC |
5 |
105.3 |
2.193 |
138.2 |
118.0 |
17.5 |
|
6 |
81.4 |
1.880 |
109.5 |
|
|
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The test method according to the regulatory accepted protocol at the time of reporting does not allow for the evaluation of eye irritation. The result does not exclude an irritation potential of the test substance. For final assignment of a risk phrase at present, results from another study would be needed.
- Executive summary:
The potential of the test substance to cause ocular irritation or serious damage to the eyes was assessed by a single topical application of 750 µL 20% test-substance preparation to the epithelial surface of isolated bovine corneas.
Three corneas were treated with the test-substance preparation for an exposure period of 4 hours. In addition to the test substance, a negative control (NC; deionized water) and a positive control (PC; 20% imidazole in deionized water) were applied to three corneas each.
Corneal opacity was measured quantitatively as the amount of light transmitted through the cornea. Permeability was measured quantitatively as the amount of sodium fluorescein dye that passes across the full thickness of the cornea. Both measurements were used to calculate an In Vitro Irritancy Score of the test substance.
The mean IVIS (8.1) of the corneas treated with the 20% test-substance preparation does not indicate serious eye damage (BCOP cut-off threshold 55). The results of the test substance, the negative control (deionized water) and the positive control (20% imidazole) fulfill the acceptance criteria and demonstrate the validity of the assay.
Based on the results observed and by applying the evaluation criteria described, it was concluded that the test substance does not cause serious eye damage in the Bovine Corneal Opacity and Permeability Test (BCOP Test) under the test conditions chosen. The test method according to the regulatory accepted protocol at the time of reporting does not allow for the evaluation of eye irritation. The result does not exclude an irritation potential of the test substance. For final assignment of a risk phrase at present, results from another study would be needed.
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.