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EC number: 915-657-7 | 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion
- Remarks:
- in vitro
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 9 July 2010 to 6 September 2010
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Fully guideline- and GLP compliant 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: Regulation (EC) 761/2009: B.46 "In vitro skin irritation: Reconstructed Human Epidermis Model Test". 23 July 2009.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 439, “In Vitro Skin Irritation: Reconstructed Human Epidermis (RhE) Test Method”, Paris 22 July 2010.
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Dresinate 835 A
- IUPAC Name:
- Dresinate 835 A
- Reference substance name:
- Reaction mass of Resin acids and Rosin acids, hydrogenated, sodium salts and sodium [1R-(1a,4aß,10aa)]-1,2,3,4,4a,9,10,10a-octahydro-7-isopropyl-1,4a-dimethylphenanthren-1-carboxylate
- IUPAC Name:
- Reaction mass of Resin acids and Rosin acids, hydrogenated, sodium salts and sodium [1R-(1a,4aß,10aa)]-1,2,3,4,4a,9,10,10a-octahydro-7-isopropyl-1,4a-dimethylphenanthren-1-carboxylate
- Details on test material:
- Trade name: Dresinate 835.
Chemical name: Abieta DRS 835.
Supplier: Sponsor.
Batch No.: AN-0400-7B.
Appearance: Yellow-brown paste.
Purity: 25-35 % water, 65-75 % sodium salt of modified rosin.
Solubility: Soluble in the most usual organic solvents; soluble in water, in the range between 30 and 60 % of solids the solution tends to gel.
pH: 9,6.
Conditions of storage: Room temperature, in the dark.
Stability at conditions of storage: Stable.
Date of expiry: Not stated.
Date of receipt: 26 April 2010.
Label on the shipping container: Abieta DRS 835, AN-0400-7B, Dresinate 835.
Constituent 1
Constituent 2
Test animals
- Species:
- other: cell model
- Strain:
- other: not appropriate
- Details on test animals or test system and environmental conditions:
- not appropriate
Test system
- Type of coverage:
- other: not appropriate
- Preparation of test site:
- other: not appropriate
- Vehicle:
- water
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: mean tissue viability
- Basis:
- mean
- Time point:
- other: 3 min
- Score:
- 107.3
- Reversibility:
- other: not appropriate
- Remarks on result:
- other: see below
- Irritation parameter:
- other: mean tissue viability
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 71.2
- Reversibility:
- other: not appropriate
- Remarks on result:
- other: see below
- Irritation parameter:
- other: mean tissue viability
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 10.1
- Reversibility:
- other: not appropriate
- Remarks on result:
- other: see below
Any other information on results incl. tables
Assay acceptance criteria, validity of the test
Epiderm Skin Corrosivity Test
The mean OD of the tissues, treated with deionised water (negative control) was 1.949 after 3 minutes, and 1.907 after 1 hour of exposure, that is higher than 0.8, as required by the assay acceptance criteria.
The mean tissue viability of the 3 minutes positive control was 16.8 %, that is lower than 30 %, as required by the assay acceptance criteria.
The maximum inter tissue viability differences of the test substance treated skin discs were 4.9 % for the 3 minutes and 25.8 % for the 1 hour exposure, that is below 30 % as required by the assay acceptance criteria.
The method was acceptable as the concurrent positive and negative control and the maximum inter tissue viability differences fell within the acceptable ranges given by the protocol INVITTOX n°119 by ECVAM.
Epiderm Skin Irritation Test
The mean OD of the tissues, treated with deionised water (negative control) was 2.030, that is higher than 1.0 and lower than 2.5, as required by the assay acceptance criteria
The mean tissue viability of the positive control was 6.1 %, that is lower than 20 %, as required by the assay acceptance criteria.
The standard deviation calculated from individual percentual tissue viabilities of the"DRESINATE 835"treated skin discs was 0.6 %, that is below 18 % as required by the assay acceptance criteria.
The method was acceptable as the concurrent positive and negative control and the standard deviation calculated from individual percentual tissue viabilities fell within the acceptable ranges given by the protocolused during the ECVAM validation study.
Cell viability measurement
Epiderm Skin Corrosivity Test
Test substance |
Mean tissue viability (%) |
Prediction |
|
3 minutes |
1 hour |
||
"DRESINATE 835" |
107.3 % |
71.2 % |
Non-Corrosive |
Epiderm Skin Irritation Test
Test substance |
Mean tissue viability (%) |
Prediction |
|
"DRESINATE 835" |
10.1 % |
Irritant |
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the results of this study, the Directive 2001/59/EC and the GHS, the test substance is considered to be non-corrosive but irritant to skin.
- Executive summary:
Aim and Method
The EpiDerm Skin Corrosivity/Irritation Test (Model EPI-200) was performed to reveal possible irreversible tissue damages of the skin following the application of "DRESINATE 835".
As the pH determination showed a pH of 9.53, no alkaline / acid reserve was determined.
The test substance wastopically applied for 3 minutes and 1 hour to the epidermal surfaces ofthree-dimensional human epidermis models, followed by immediate determination of the cytotoxic effect. As there was no corrosive effect observed, the test substance wastopically applied for 60 minutes to the epidermal surfaces ofthree-dimensional human epidermis models. After a post-incubation of 42 hours, a cell viability test was performed. Investigations performed were in conformance with theRegulation (EC) 440/2008: B.40.BIS. "In vitro skin corrosion: human skin model", theOECD-Guideline 431, "In Vitro Skin Corrosion: Human Skin Model Test ",, the OECD Guideline “In Vitro Skin Irritation: Reconstructed Human Epidermis (RhE) Test Method”,, the ESAC statement,and theRegulation (EC) 761/2009: B.46 "In vitro skin irritation: Reconstructed Human Epidermis Model Test"..Results
EpiDerm Skin Corrosivity Test
Assay acceptance criteria according to the protocol INVITTOX n°119 by ECVAM:
· The mean optical density (OD) of the tissues, treated with deionised water (negative control) was 1.949 after 3 minutes, and 1.907 after 1 hour of exposure, that is higher than 0.8, as required by the assay acceptance criteria.
· The mean tissue viability of the 3 minutes positive control was 16.8 %, that is lower than 30 %, as required by the assay acceptance criteria.
· The maximum inter tissue viability differences of the "DRESINATE 835" treated skin discs were 4.9 % for 3 minutes and 25.8 % for 1 hour exposure, that is below 30 % as required by the assay acceptance criteria.
"DRESINATE 835":
· The mean percentage viability of the treated skin discs after 3 minutes of exposure was 107.3 % which is above the threshold of 50 % for classification.
· The mean percentage viability of the treated skin discs after 1 hour of exposure was 71.2 % which is above the threshold of 15 % for classification.
EpiDerm Skin Irritation Test
Assay acceptance criteria:
· The mean OD of the tissues, treated with deionised water (negative control) was 2.030, that is higher than 1.0 and lower than 2.5, as required by the assay acceptance criteria.
· The mean tissue viability of the positive control was 6.1 %, that is lower than 20 %, as required by the assay acceptance criteria.
· The standard deviation calculated from individual percentual tissue viabilities of the "DRESINATE 835" treated skin discs was 0.6 %, that is below 18 % as required by the assay acceptance criteria.
"DRESINATE 835":
· The mean percentage viability of the treated skin discs was 10.1 % which is below the threshold of 50 % for classification.
Conclusion
According to the results of this study, the Directive 2001/59/EC and the GHS, the test substance "DRESINATE 835" is considered to be non-corrosive but irritant to skin.
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