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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 612-028-6 | CAS number: 607724-47-0
- 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
- Blendazol Red is considered as non-corrosive to skin.
- Blendazol Red is not classified as eye irritant
According to OECD Guideline no. 437 (Jul. 2013), a substance with an IVIS > 3 and ≤ 55 induces effects on the cornea, that cannot be classified in an UN GHS Category.
Blendazol Red Blendwell showed effects on the cornea of the bovine eye. with an IVIS = 10.1, accordingly Blendazol is not classified as eye irritant
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Remarks:
- BCOP Test Method
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11. May. 2017- 23. May. 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- 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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- cattle
- Strain:
- other: Bovine cornea collected from slaughtered cattle
- Details on test animals or tissues and environmental conditions:
- - Source: Bos primigenius Taurus (fresh bovine corneas)
Fresh bovine eyes were obtained from the slaughterhouse Müller Fleisch GmbH, Enzstr. 2-4, 75217 Birkenfeld, Germany, on the day of the test. The cattle were between 12 and 60 months old. The eyes were transported to the test facility in Hank’s balanced salt solu-tion (supplemented with 0.01% streptomycin and 0.01% penicillin). Then, the corneas were dissected and incubated in medium at 32 ± 1 °C in an incubation chamber for 1 h.
- indication of any existing defects or lesions in ocular tissue samples: no existing defects
-- Source:the slaughterhouse Müller Fleisch GmbH, Enzstr. 2-4, 75217 Birkenfeld, Germany
- Number of animals: not specified
- Characteristics of donor animals (e.g. age, sex, weight): The cattle were between 12 and 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 transported to the test facility in Hank’s balanced salt solution (supple-mented with 0.01% streptomycin and 0.01% penicillin). - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
Amounts of Test Item
Tissue Amount
1 423.8 mg
2 444.1 mg
3 464.4 mg - Duration of treatment / exposure:
- 4 hours at 32 ± 1 °C
- Duration of post- treatment incubation (in vitro):
- 90 min
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS:
the corneas were examined and only corneas which were free from damages were used. 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 cMEM (32 ± 1 °C) without phenol red was filled. The holders were then incubated for 1 hour in the incubation chamber at 32 ± 1 °C
QUALITY CHECK OF THE ISOLATED CORNEAS:
the corneas were examined and only corneas which were free from damages were used
NUMBER OF REPLICATES: 3
NEGATIVE CONTROL USED: HBSS
SOLVENT CONTROL USED (if applicable)
POSITIVE CONTROL USED: Imidazole, 20% solution in HBSS
APPLICATION DOSE AND EXPOSURE TIME: 4h
Tissue Amount
1 423.8 mg
2 444.1 mg
3 464.4 mg
TREATMENT METHOD: open chamber
The “open chamber-method” is used for solid substances.
In order to apply the test item, the nut was unscrewed to remove the glass disc. The test item could be applied directly on the cornea now
POST-INCUBATION PERIOD: yes.
duration : 1h
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period:2
- POST-EXPOSURE INCUBATION:90 min
METHODS FOR MEASURED ENDPOINTS:
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of [UV/VIS spectrophotometry / microtiter plate reader] (OD490)
SCORING SYSTEM: In Vitro Irritancy Score (IVIS): 10.31
DECISION CRITERIA: please specify if the decision criteria as indicated in the TG was used. yes
The test item was tested pure.
Under the conditions of this test, the test item Blendazol Red Blendwell showed effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 10.31.
According to OECD Guideline no. 437 (Jul. 2013), a substance with an IVIS > 3 and ≤ 55 induces effects on the cornea, that cannot be classified in an UN GHS Category.
The negative control (HBSS) and the positive control (20% imidazole solution) have met the validity criteria - Irritation parameter:
- cornea opacity score
- Value:
- ca. 10.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
-
DEMONSTRATION OF TECHNICAL PROFICIENCY:
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes 1.18 ≤ 3
- Acceptance criteria met for positive control: 104.68 witch falls between 72.85 – 165.65
9.3 Validity
According to the guideline, the test is considered as valid if the positive control causes an IVIS that falls within two standard deviations of the current historical mean.
The negative control has to show an IVIS ≤ 3.
The validity criteria and findings are given in the following table:
Table 9.3 a Validity
Parameter Criterion Found Assessment
IVIS of negative control
HBSS-solution ≤ 3 1.18 ok
IVIS of positive control
20% imidazole solution 72.85 – 165.65 104.68 ok
Values for negative and positive controls were within the range of historical data of the test facility (see historical data). Therefore, the test system was acceptable.
- Range of historical values if different from the ones specified in the test guideline:
COMPARISON WITH HISTORICAL DATA
In the following table, the means of the negative control and positive control of all experi-ments which were performed with this positive control up to 06. Apr. 2017 are stated and compared with the values which were found in this study.
Table 14 a Historical Data
Negative Control Positive Control
Mean IVIS 1.95 119.25
Standard Deviation IVIS 1.01 23.20
Range of IVIS (validity) ≤ 3 72.85 – 165.65
Study 17031402G850 1.18 104.68
Mean Opacity 1.70 82.66
Standard Deviation
Opacity 1.00 18.02
Range of Opacity -1.86 – 4.08 42.92 – 133.11
Study 17031402G850 1.10 77.40
Mean Permeability 0.02 2.48
Standard Deviation Per-meability 0.02 1.00
Range of Permeability -0.01 – 0.10 0.75 – 5.89
Study 17031402G850 0.01 1.82 - Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to OECD Guideline no. 437 (Jul. 2013), a substance with an IVIS > 3 and ≤ 55 induces effects on the cornea, that cannot be classified in an UN GHS Category.
In the negative control, no signs of eye irritation were observed.
The positive control induced serious eye damage, which would be classified as GHS cat-egory 1.
The test item Blendazol Red Blendwell showed effects on the cornea of the bovine eye.
The calculated IVIS (in vitro irritancy score) is 10.31.
The experiment is considered as sufficient for the classification of the test item, because all three replicates of the test item lead to the same assessment for the test item - Executive summary:
The eye irritation of the test Blendazol Red was determined using the Bovine Corneal Opacity and Permeability (BCOP) Test Method according to the OECD Guideline 437 and EU Method B.47
Bovine corneas were used. They were collected from slaughtered cattle which were between 12 and 60 months old.
The test item Blendazol Red Blendwell was brought onto the cornea of a bovine eye which had been incubated with cMEM without phenol red at 32 ± 1 °C for 1 hour and whose opacity had been measured.
The test item was incubated on the cornea for 4 hours at 32 ± 1 °C. After removal of the test item, opacity and permeability values were measured.
HBSS-solution was used as negative control. The negative control showed no irritating effect on the cornea and the calculated IVIS (in vitro irritancy score) is 1.18.
20% imidazole solution was used as positive control. The positive control induced serious eye damage on the cornea and falls within two standard deviations of the current historical mean. The calculated IVIS (in vitro irritancy score) is 104.68.
Under the conditions of this study, the test item Blendazol Red Blendwell showed effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 10.31.
According to OECD Guideline no. 437 (Jul. 2013), a substance with an IVIS > 3 and ≤ 55 induces effects on the cornea, that cannot be classified in an UN GHS Category for eye damage.
Reference
1.1 IVIS Values
The calculated IVIS for each replicate and the corresponding means are presented in the following table:
Table9.2‑a IVIS
Test Group |
IVIS |
Mean IVIS |
Relative Standard Deviation IVIS |
Negative Control |
2.37 |
1.18 |
94.07% |
1.02 |
|||
0.16 |
|||
Test Item |
13.26 |
10.31 |
26.30% |
9.72 |
|||
7.94 |
|||
Positive Control solution |
99.47 |
104.68 |
23.84% |
82.75 |
|||
131.83 |
Note: the high relative standard deviation of the IVIS of the negative control is due to mathematical reasons, as the respective means are very small.
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
The relative absorbance values of the test item were increased to 109.7% after 3 minutes treatment. This value is above the threshold for corrosivity (50%). After 1 hour treatment, the relative absorbance values of the test item were reduced to 93.0%, lying above the threshold for corrosivity (15%). Therefore, the test item is considered as non-corrosive to skin.
According to OECD Guideline no. 437 (Jul. 2013), a substance with an IVIS > 3 and ≤ 55 induces effects on the cornea, that cannot be classified in an UN GHS Category.
In the negative control, no signs of eye irritation were observed.
The positive control induced serious eye damage, which would be classified as GHS cat-egory 1.
The test item Blendazol Red Blendwell showed effects on the cornea of the bovine eye.
The calculated IVIS (in vitro irritancy score) is 10.31.
The experiment is considered as sufficient for the classification of the test item, because all three replicates of the test item lead to the same assessment for the test item
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.