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EC number: 931-584-3 | CAS number: 66071-92-9
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 2009 - May 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Fully Guideline- and GLP-compliant
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: OECD-Guideline 431, "In Vitro Skin Corrosion: Human Skin Model Test ", 13 April 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: DRAFT OECD Guideline “In vitro Skin irritation: Reconstructed Human Epidermis (RhE) Test Method”, Paris 11 December 2009 (Version 4)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: ESAC statement, 5 November 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Regulation (EC) 761/2009: B.46 "In vitro skin irritation: Reconstructed Human Epidermis Model Test". 23 July 2009
- Deviations:
- no
- Principles of method if other than guideline:
- Firstly the pH and the alkaline reserve was determined. As the calculation of the alkalinereserve allowed the classification as irritating, no EpiDerm Skin Irritation Test was performed.As the calculation of the alkaline reserve yielded a negative result for classification ascorrosive the test substance was topically applied for 3 minutes and 1 hour to the epidermalsurfaces of three-dimensional human epidermis models, followed by immediatedetermination of the cytotoxic effect. The corrosivity test was repeated twice (Experiment A,Experiment B).
- GLP compliance:
- yes
Test material
- Reference substance name:
- Spent liquor from alkaline pulping and bleaching containing spent inorganic process chemicals and dissolved organic substances originating from the cellulosic raw material.
- EC Number:
- 931-584-3
- Cas Number:
- 66071-92-9
- Molecular formula:
- UVCB substance, not available. View remarks field.
- IUPAC Name:
- Spent liquor from alkaline pulping and bleaching containing spent inorganic process chemicals and dissolved organic substances originating from the cellulosic raw material.
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): Black liquor- Substance type: UVCB- Physical state: liquid
Constituent 1
Test animals
- Species:
- other: in vitro system
- Strain:
- other: MatTek´s EpiDerm System
- Details on test animals or test system and environmental conditions:
- MatTek´s EpiDerm System consists of normal, human-derived epidermal keratinocytes whichhave been cultured form a multilayered, highly differentiated model of the human epidermis.It consists of organized basal, spinous and granular layers, and a multi-layered stratumcorneum containing intercellular lamellar lipid layers arranged in patterns analogous to thosefound in vivo. The EpiDerm™ tissues (surface 0.6 cm²) are cultured on specially preparedcell culture inserts (MILLICELLs®, 10 mm ∅) and shipped as kits, containing 24 tissues onshipping agarose.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: n.a.
- Amount / concentration applied:
- 50 μL of the test substance were dispensed directly atop the Epi-200 tissue.
- Duration of treatment / exposure:
- Exposure times:• 3 minutes• 1 hour
- Observation period:
- n.a.
- Number of animals:
- Two tissue replicates were used for each treatment (exposure time), including deionisedwater as negative and 8N KOH as positive control.
- Details on study design:
- Determination of pH and alkaline / acid reservePrior to starting the Epiderm Skin Corrosivity Test the pH-value of a 10 % (w/w) aqueoussolution of the test substance and the alkaline / acid reserve were determined.Substances with a pH < 2.0 or pH > 11.5 and a high buffering capacity need not to be testedfor skin corrosion.Epiderm Skin Corrosivity TestTwo tissue replicates were used for each treatment (exposure time), including deionisedwater as negative and 8N KOH as positive control.Exposure times:• 3 minutes• 1 hour50 μL of each reference substance were dispensed directly atop the EpiDerm™ tissue.50 μL of the test substance were dispensed directly atop the Epi-200 tissue.MTT-testAfter incubation with the test substance and washing with PBS, the tissues were incubatedwith MTT medium at 37°C and 5 % CO2. After 3 hours, the MTT medium was aspirated fromall wells and the tissues were gently rinsed with PBS (2 times). For extraction, the tissueswere incubated with extractant solution (isopropanol) for 2 hours with shaking.After the extraction period, the tissues were pierced with an injection needle and the extract(now a blue formazan solution) was allowed to run into the well from which the tissue wastaken. The 24-well plates were placed on a shaker for 15 minutes until the solutions werehomogeneous in colour.Per each tissue 3 × 200 μL aliquots of the blue formazan solution were transferred into a 96-well flat bottom microtiter plate (see plate design Figure 1) and the OD was measured usingthe extractant solution as blank in a plate spectrophotometer at 570 nm, without referencefilter.CalculationsDetermination of alkaline reserveThe volume of HCl required to titrate to a pH of 10.00 is measured. The alkaline reserveexpressed as grams of sodium hydroxide in 100 ml of sample is calculated.Cell viabilityCell viability was calculated for each tissue as percent of the mean of the negative controltissues. The skin corrosivity/irritation potential of the test substance was classified accordingto remaining cell viability obtained after test substance treatment with either of the twoexposure times.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: Mean tissue viability (%)
- Basis:
- mean
- Time point:
- other: 3 minutes
- Score:
- 94.5
- Reversibility:
- other: n.a.
- Remarks on result:
- other: Non-Corrosive
- Irritation parameter:
- other: Mean tissue viability (%)
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 40.6
- Reversibility:
- other: n.a.
- Remarks on result:
- other: Non-Corrosive
- Irritant / corrosive response data:
- Determination of pH and alkaline reserve:The pH of a 10 % (w/w) aqueous solution of "BLACK LIQUOR" was 12.35 which is higherthan 11.5, thus the alkaline reserve was determined.The pH + 1/12 alkaline reserve was 12.60 which is below the threshold of 14.5 forclassification as corrosive and the pH + 1/6 alkaline reserve was 13.04 which is above thethreshold of 13 for classification as irritant.Epiderm Skin Corrosivity Test, Experiment A:• The mean percentage viability of the treated skin discs after 3 minutes of exposure was94.5 % which is above the threshold of 50 % for classification.• The mean percentage viability of the treated skin discs after 1 hour of exposure was40.6 % which is above the threshold of 15 % for classification.Epiderm Skin Corrosivity Test, Experiment B:• The mean percentage viability of the treated skin discs after 3 minutes of exposure was92.6 % which is above the threshold of 50 % for classification.• The mean percentage viability of the treated skin discs after 1 hour of exposure was30.7 % which is above the threshold of 15 % for classification.
- Other effects:
- Assay acceptance criteria according to the protocol INVITTOX n°119 by ECVAM:Epiderm Skin Corrosivity Test, Experiment A:• The mean optical density (OD) of the tissues, treated with deionised water (negativecontrol) was 1.990 after 3 minutes, and 2.111 after 1 hour of exposure, that is higher than0.8, as required by the assay acceptance criteria.• The mean tissue viability of the 3 minutes positive control was 24.1 %, that is lower than30 %, as required by the assay acceptance criteria.• The maximum inter tissue viability differences of the "BLACK LIQUOR" treated skin discswere 12.5 % for 3 minutes and 52.5 % for 1 hour exposure, that is below 30 % as requiredby the assay acceptance criteria for the 3 minutes exposure, but above 30 % for the 1hour exposure. However, since the test substance was very sticky on the skin, it wasimpossible to wash away the test substance completely after the 1 hour treatment. This ismost probably the explanation for the variation. Since the test substance is classified asnon-corrosive, there is no problem with the validity of the results,although the test substance was most probably not completely removed after 1 hour.Epiderm Skin Corrosivity Test, Experiment B:• The mean optical density (OD) of the tissues, treated with deionised water (negativecontrol) was 2.239 after 3 minutes, and 2.223 after 1 hour of exposure, that is higher than0.8, as required by the assay acceptance criteria.• The mean tissue viability of the 3 minutes positive control was 27.8 %, that is lower than30 %, as required by the assay acceptance criteria.• The maximum inter tissue viability differences of the "BLACK LIQUOR" treated skin discswere 4.7 % for 3 minutes and 51.6 % for 1 hour exposure, that is below 30 % as requiredby the assay acceptance criteria for the 3 minutes exposure, but above 30 % for the 1hour exposure. However, since the test substance was very sticky on the skin, it wasimpossible to wash away the test substance completely after the 1 hour treatment. This ismost probably the explanation for the variation. Since the test substance is classified asnon-corrosive, there is no problem with the validity of the results,although the test substance was most probably not completely removed after 1 hour.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- According to the results of this study and the Directive 2001/59/EC, the test substance "BLACK LIQUOR" is considered to be non-corrosive and irritant to skin.
- Executive summary:
The Epiderm Skin Corrosivity/Irritation Test (Model EPI-200) was performed to reveal
possible irreversible tissue damages of the skin following the application of
"BLACK LIQUOR".
Firstly the pH and the alkaline reserve was determined:
The pH of a 10 % (w/w) aqueous solution of "BLACK LIQUOR" was 12.35 which is higher
than 11.5, thus the alkaline reserve was determined.
As the calculation of the alkaline reserve allowed the classification as irritating (the pH + 1/6 alkaline reserve was 13.04
which is above the threshold of 13), no EpiDerm Skin Irritation Test was performed.
As the calculation of the alkaline reserve yielded a negative result for classification as
corrosive (pH + 1/12 alkaline reserve was 12.60 which is below the threshold of 14.5)
the test substance was topically applied for 3 minutes and 1 hour to the epidermalsurfaces of three-dimensional human epidermis models, followed by immediate
determination of the cytotoxic effect. The corrosivity test was repeated twice (Experiment A,
Experiment B).
Epiderm Skin Corrosivity Test, Experiment A:
• The mean percentage viability of the treated skin discs after 3 minutes of exposure was
94.5 % which is above the threshold of 50 % for classification.
• The mean percentage viability of the treated skin discs after 1 hour of exposure was
40.6 % which is above the threshold of 15 % for classification.
Epiderm Skin Corrosivity Test, Experiment B:
• The mean percentage viability of the treated skin discs after 3 minutes of exposure was
92.6 % which is above the threshold of 50 % for classification.
• The mean percentage viability of the treated skin discs after 1 hour of exposure was
30.7 % which is above the threshold of 15 % for classification.
Conclusion
According to the results of this study and the Directive 2001/59/EC, the test substance
"BLACK LIQUOR" is considered to be non-corrosive and irritant to skin.
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