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EC number: 228-412-8 | CAS number: 6262-07-3
- 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
The average viability of tissues treated by the test substance Acid Black 26 was, after corection, 78.9 % of negative control average value, i.e. viability was > 50 %. The effect of the test item was negative in EpiDermTM model (tissues were not damaged).
No pathological changes of eyes of all rabbits were observed. During the observation period 48 and 72 hours after application no irritating effects on the eye was observed in all animals. No clinical signs of systemic intoxication were detected. Evaluation of results after single application demonstrated that the test substance, Acid Black 26, is not irritating to eye of rabbit.
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:
- 08.12.2015 – 22.01.2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- Adopted: 28th July, 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- Commission Regulation (EC) No. 640/2012, 6th June 2012
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: tissue for research puposes from accredited institutions
- Source strain:
- other: Keratinocyte strain 00267
- Vehicle:
- water
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUEViable tissues: the reconstructed human epidermal model EpiDerm (EPI-200 ver. 2.0, MatTek, Bratislava, Slovakia); Lot Nos. 23306 and 23308Frozen tissues: the reconstructed human epidermal model EpiDermTM killed by freezing; Lot No.: 16888 FRZN EATEMPERATURE USED FOR TEST SYSTEMculture conditions 37±1°C, 5±1 % CO2, moistened tissueREMOVAL OF TEST MATERIAL AND CONTROLS- Volume and number of washing steps: thoroughly rinsed, blotted to remove the test substance- Observable damage in the tissue due to washing: yes (see Other effects/acceptance ...)MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE- MTT concentration: 1 mg·mL-1- Incubation time: 180 min- Spectrophotometer: Libra S22 at 570 nm. Isopropyl alcohol serves as a blank. FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATABased on Certificate of Analysis the model passed all parametres for viability, barrier function, sterility.NUMBER OF REPLICATE TISSUES: 3CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE- killed tissues- Procedure used to prepare the killed tissues (if applicable): by freezing- N. of replicates : 2- Method of calculation used: see Any other information ...NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION:1. Direct MTT reduction - functional check in tubes2. Direct MTT reduction - test in frozen tissues3. MTT test in viable tissues - two experimentsPREDICTION MODEL / DECISION CRITERIAOECD Test Guideline No. 439 (1), par. 36:- In case the test chemical is found to be non-corrosive (e.g., based on TG 430, 431 or 435), and shows tissue viability after exposure and post-treatment incubation is less than or equal (≤) to 50%, the test chemical is considered to be irritant to skin in accordance with UN GHS (3) Category 2. - The test chemical may be considered as non-irritant to skin in accordance with UN GHS No Category if the tissue viability after exposure and post-treatment incubation is more than (>) 50%.
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- The test substance (25 mg) was placed directly atop to the moistened tissue. The material was spread on the tissue surface.NC: sterile PBS (phosphate buffered saline)PC: 5 % SDS (sodium dodecyl sulphate), MatTek, Lot No. 020615TMH in water
- Duration of treatment / exposure:
- 60±5 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hours.
- Number of replicates:
- 3
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 2
- Value:
- 78.9
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- Criterium #3 for SD of among tissues was not fulfilled in the first experiment. The first experiment was repeated and its results were not taken into evaluation.Difficulties were observed at washing and not all the test substance was removed from tissues. Sometimes, tissues were damaged at removal of the test substance. At the same time, utmost thorough removal of the test substance was very important because the test substance reduces MTT directly. Damage of tissues could be the one of reasons why OD570 values were so different at the first experiment. At the same time, the test substance directly reducing MTT, remained bounded in tissues in different amount.In the second experiment, longer time gaps were let between tissues due to possibility to better removal of the test substance from tissues. Unfortunatelly, it was not very effective, because the test substance was bounded in tissues, so its removal was impossible. Nevertheless, all test conditions were fulfilled and the results of the second experiment were evaluated. In the second experiment the first tissue of negative control was about 25 min lost in internals of laminar box and drained. This tissue was excluded from evaluation.In the repeated experiment all criteria for validity of the test were fulfilled.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the above-described experimental design, average viability of tissues treated by the test substance Acid Black 26 was, after correction, 78.9 % of negative control average value, i.e. viability was > 50 %. The effect of the test item was negative in EpiDermTM model (tissues were not damaged).
- Executive summary:
The test item, Acid Black 26, was assayed for the in vitro skin irritation in human epidermal model EpiDermTM. The test was performed according to the OECD Test Guideline No. 439: In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method test (2015) and Protocol for: In Vitro EpiDermTMSkin Irritation Test For use with MatTek Corporation’s Reconstructed Human Epidermal Model EPI-200-SIT (2014).
After pre-incubation of tissues, 25 mg of the test substance was placed directly atop to the previously moistened tissue and it was spread on the entire tissue surface. Length of exposition was 60 minutes. Three tissues were used for the test substance and every control.
After removal of the test substance, tissues were post-incubated for approximately 42 hours due to leave of damage reparation. Three hours incubation with MTT and two hours extraction period with shaking followed then. Optical density (OD570) of isopropyl alcohol extracts was measured on a spectrophotometer. Relative cell viability was calculated for each tissue as % of the mean viability of the negative control tissues.
As the test substance was suspected to be direct reducing, test with frozen tissues was performed to detection if the tets substance remaining in tissues reduces MTT directly. Direct reduction in tissues was confirmed and result in viable tissue was corrected.
Under the above-decribed experimental design, average viability of tissues treated by the test substance was 78.9 %, i.e. viability was > 50 %.
The effect of the test substance was negative in EpiDermTMmodel (tissues were not damaged).
According to the classification criteria, the test substance is considered to have no category in regard to skin irritation.
Reference
Direct MTT reduction: test in frozen tissues
Treatment | tissue 1 | tissue 2 | mean | SD | %NC | 95% conf. interval | |
PBS 60 min | 0.055 | 0.060 | 0.058 | 0.003 | 100.0 | 0.053 | 0.063 |
446/15 (60 min) | 0.096 | 0.139 | 0.118 | 0.022 | 204.3 | 0.075 | 0.161 |
Average OD570value of treated tissues after 60 min treatment (0.118) did not fall into 95% confidence interval of negative control so correction of results of MTT test is necessary.
MTT test: viable tissues
OD570values obtained at the MTT test, their averages, standard deviations (%) and relative viabilities
The first experiment:
Treatment | OD570 |
|
| Mean | SD | %NC |
PBS (NC) | 1.984 | 1.910 | 1.879 | 1.924 | 0.044 |
|
viability (%NC) | 103.1 | 99.3 | 97.6 | 100.0 | 2.3 | 100.0 |
446/15 (C2) | 0.878 | 1.733 | 0.911 | 1.174 | 0.396 |
|
viability (%NC) | 45.6 | 90.1 | 47.3 | 61.0 | 20.6 | 61.0 |
5% SDS (PC) | 0.056 | 0.077 | 0.070 | 0.068 | 0.009 |
|
viability (%NC) | 2.9 | 4.0 | 3.6 | 3.5 | 0.5 | 3.5 |
The second experiment:
Treatment | OD570 |
|
| Mean | SD | %NC |
PBS (NC) | 0.179 | 1.855 | 1.832 | 1.844 | 0.012 |
|
viability (%NC) | 9.7 | 100.6 | 99.4 | 100.0 | 0.6 | 100.0 |
446/15 (C2) | 1.999 | 1.310 | 1.602 | 1.637 | 0.282 |
|
viability (%NC) | 108.4 | 71.1 | 86.9 | 88.8 | 15.3 | 88.8 |
5% SDS (PC) | 0.075 | 0.065 | 0.069 | 0.070 | 0.004 |
|
viability (%NC) | 4.1 | 3.5 | 3.7 | 3.8 | 0.2 | 3.8 |
0.179 - tissue excluded from evaluation
PBS - phosphate buffered saline
SDS - sodium dodecyl sulphate
Interference by the test substance (OD570= 0.118) was lower than 30% of viable negative control, so correction of second experiment results was made.
True viability (OD570) = 1.637 - 0.118 = 1.519
True viability (% of negative control) is 78.9.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15.02. – 24.02.2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- Adopted October 2, 2012
- Deviations:
- yes
- Remarks:
- (see Any other information ...)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS- Source: breeding farm VELAZ s.r.o., Lysolaje, Czech Republic, RČH CZ 21760118- Weight at study initiation: 2.70 – 3.40 kg- Housing: conventional animal room – individually in metallic cages- Diet (e.g. ad libitum): ad libitum- Water (e.g. ad libitum): ad libitum- Acclimation period: 5 days, no signs of disease were observedENVIRONMENTAL CONDITIONS- Temperature (°C): 20 ± 3°C, permanently monitored- Humidity (%): 30 – 70%, permanently monitored- Photoperiod (hrs dark / hrs light): 12 h/12 h
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- A dose of 100 mg of the test substance was applied to the test site in supplied form.
- Duration of treatment / exposure:
- The test substance was placed into the conjunctival sac of one eye of animals after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second in order to prevent loss of the substance. The substance was solid and has not been removed from the eye of the test animal by physiological mechanisms at the first observation time point of 1 hour after treatment. The eye was rinsed with physiological saline solution.
- Observation period (in vivo):
- examined at 1, 24, 48 and 72 hours after application
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE - Washing (if done): rinsed with physiological saline solution - Time after start of exposure: 1h SCORING SYSTEM: To the ocular reactions observed at each time interval the grades were assigned according to the grading system given in OECD Test Guideline No. 405 Acute Eye Irritation/Corrosion. Adopted October 2, 2012. TOOL USED TO ASSESS SCORE: hand-slit lamp
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Redness of conjunctivae (some blood vessels of conjunctivae were hyperaemic (injected)) and chemosis of lids (some swelling above normal) were observed in all animals 1 hour after application of test substance. Due to coloration of the test substance the evaluation of irritation was difficult.No changes were observed on eye at 24 hour after application in animals 3 and 5. Only in animal No. 1: Conjunctivae - Some blood vessels were hyperaemic (injected). No pathological changes of eyes of all rabbits were observed for the rest of the study. During the observation period (48 and 72 hours after application) no irritating effects on the eye was observed in all animals. No clinical signs of systemic intoxication were detected. Evaluation of results after single application demonstrated that the test substance, Acid Black 26, is not irritating to eye of rabbit.
- Executive summary:
The test substance, Acid Black 26, was tested for the assessment of eye irritation/corrosion effects using albino rabbit (New Zealand Albino breed).
The test was performed according to the OECD Test Guideline No. 405 Acute Eye Irritation/Corrosion. Adopted October 2, 2012.
The strategy given in this OECD test guideline was respected, initial consideration and weight-of-the-evidence analysis was performed before in vivo testing.
The test was performed initially using one animal (No. 1). Because no corrosive or severe irritating effects were observed in initial test, the response was confirmed using two additional animals (No. 3 and No. 5).
Redness of conjunctivae (some blood vessels of conjunctivae were hyperaemic (injected) and chemosis of lids (some swelling above normal) were observed in all animals 1 hour after application of test substance. Due to coloration of the test substance the evaluation of irritation was difficult.
No changes were observed on eye at 24 hour after application in animals 3 and 5. Only in animal No. 1: Conjunctivae - Some blood vessels were hyperaemic (injected). No pathological changes of eyes of all rabbits were observed for the rest of the study. During the observation period (48 and 72 hours after application) no irritating effects on the eye was observed in all animals. No clinical signs of systemic intoxication were detected.
Evaluation of results after single application demonstrated that the test substance, Acid Black 26, is not irritating to the eye of rabbit.
Reference
No alterations of control eyes were observed during the whole study.
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
Under the above-described experimental design, average viability of tissues treated by the test substance Acid Black 26 was, after correction, 78.9 % of negative control average value, i.e. viability was > 50 %. The effect of the test item was negative in EpiDermTM model (tissues were not damaged).
No pathological changes of eyes of all rabbits were observed. During the observation period 48 and 72 hours after application no irritating effects on the eye was observed in all animals. No clinical signs of systemic intoxication were detected. Evaluation of results after single application demonstrated that the test substance, Acid Black 26, is not irritating to eye of rabbit.
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