Registration Dossier
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EC number: 618-303-7 | CAS number: 89786-04-9
- 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

Endpoint summary
Administrative data
Description of key information
Skin corrosion/irritation:
Key study. Test method according to OECD 431 and EU B.40 Bis. GLP study. The substance is not corrosive or irritant to reconstructed human epidermis model based on cell viability.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation / corrosion
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to
- Guideline:
- other: B.40 Bis In vitro skin corrosion: Human skin model test
- Deviations:
- no
- Qualifier:
- according to
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Deviations:
- no
- GLP compliance:
- yes
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: Reconstructed Human Epidermis
- Source strain:
- other: MatTek´s EpiDerm System
- Details on animal used as source of test system:
- Reconstructed Human Epidermis.
- Justification for test system used:
- In vitro validated system.
- Vehicle:
- water
- Details on test system:
- The Epiderm Skin Corrosivity/Irritation Test (Model EPI-200) was performed to reveal possible irreversible tissue damages of the skin following the application of the test substance. Firstly the test substance was topically applied for 3 minutes and 1 hour to the epidermal surfaces of three-dimensional human epidermis models, followed by immediate determination of the cytotoxic effect. As there was no corrosive effect observed, the test substance was topically applied for 15 minutes to the epidermal surfaces of three-dimensional human epidermis models. After a post-incubation of 42 hours, a cell viability test was performed.
Test system
MatTek´s EpiDerm System consists of normal, human-derived epidermal keratinocytes which have 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 stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. The EpiDerm™ tissues (surface 0.6 cm²) are cultured on specially prepared cell culture inserts (MILLICELLs, 10 mm diameter) and shipped as kits, containing 24 tissues on shipping agarose. - Control samples:
- not required
- Amount/concentration applied:
- Application of the reference substances:
50 µL of each reference substance were dispensed directly atop the Epi-200 tissue.
Application of the test substance:
The application spoon was filled with 25 mg finely grounded test substance. The "spoonful" was levelled by gently scratching the excess material away, avoiding compression.
25 µL H2O were added for wetting of the test substance. - Duration of treatment / exposure:
- Epiderm Skin Corrosivity Test: Exposure times were 3 minutes and 1 hour.
Epiderm Skin Irritation Test: Exposure time was 15 minutes. - Duration of post-treatment incubation (if applicable):
- 42 h.
- Number of replicates:
- Two tissue replicates were used for each treatment (exposure time) in the corrosivity test.
Three tissue replicates were used for each treatment (exposure time) in the irritation test. - Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Corrosivity test
- Value:
- 101.3
- Remarks on result:
- other: 3 min exposure.
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Corrosivity test
- Value:
- 125.5
- Remarks on result:
- other: 1h exposure
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Irritation test
- Value:
- 97.93
- Remarks on result:
- other: 3 min exposure
- Irritant / corrosive response data:
- Corrosivity test:
Mean tissue viability = 101.3 % (3 min exposure).
Mean tissue viability = 125.5 % (1 h exposure).
Irritation test:
Mean tissue viability = 97.93 % (3 min exposure). - Interpretation of results:
- GHS criteria not met
- Remarks:
- CLP Implementation.
- Conclusions:
- Conclusion
According to the results of this study, the test substance is considered to be non-corrosive and non-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 "TAZOBACTAM ACID".
Firstly the test substance was topically applied for 3 minutes and 1 hour to the epidermal surfaces of three-dimensional human epidermis models, followed by immediate determination of the cytotoxic effect. As there was no corrosive effect observed, the test substance was topically applied for 15 minutes to the epidermal surfaces of three-dimensional human epidermis models. After a post-incubation of 42 hours, a cell viability test was performed.
Investigations performed were in conformance with the Directive 2000/33/EC, B. 40, "Skin corrosion", the OECD-Guideline 431, "In Vitro Skin Corrosion: Human Skin Model Test ", 13 April 2004 and the ESAC statement, 27 April 2007.
Results:
Corrosivity test:
Mean tissue viability = 101.3 % (3 min exposure).
Mean tissue viability = 125.5 % (1 h exposure).
Irritation test:
Mean tissue viability = 97.93 % (3 min exposure).
According to the results of this study , the test substance is considered to be non-corrosive and non-irritant to skin.
Reference
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 2.560 after 3 minutes, and 1.936 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 14.9 %, 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 10.6 % for 3 minutes and 0.1 % for 1 hour exposure, that is below 30 % as required by the assay acceptance criteria.
Test substance:
The mean percentage viability of the treated skin discs after 3 minutes of exposure was 101.3 % which is above the threshold of 50 % for classification.
The mean percentage viability of the treated skin discs after 1 hour of exposure was 125.5 % which is above the threshold of 15 % for classification.
Epiderm Skin Irritation Test:
Assay acceptance criteria according to the protocol used during the ECVAM validation study:
- The mean OD of the tissues, treated with deionised water (negative control) was 1.799 , that is higher than 1.0, as required by the assay acceptance criteria.
- The mean tissue viability of the positive control was 6.88 %, that is lower than 20 %, as required by the assay acceptance criteria.
- The standard deviation calculated from individual percentual tissue viabilities of the test substance treated skin discs was 4.42, that is below 11 as required by the assay acceptance criteria.
Test substance:
The mean percentage viability of the treated skin discs was 97.93 % which is above the threshold of 50 % for classification.
According to the results of this study and the Directive 2001/59/EC, the test substance is considered to be non-corrosive and non-irritant to skin
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
Based on the available information, the substance is not classified for skin irritation/corrosion according to CLP Regulation (EC) No 1272/2008.
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