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Diss Factsheets
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EC number: 211-669-5 | CAS number: 683-10-3
- 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
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Endpoint summary
Administrative data
Description of key information
Skin Irritation -
Mean value of three test data on a 35 active solution of the substance gave a value of 7.8% mean issue viability in the EpiDerm skin test (OECD 439).
Accoridng to the test protocol, a value of <=50% predicts Irritant GHS Cat 2.
Eye Irritation -
Under the conditions of the test, the sample eliicited an average in vitro score of 30.7.
The positive control elicited an average in vitro score of 46.0.
Under the decision cirteria of this test, these values fall within the 'No prdictions can be made' category.
However, since the test sample was only 35% active and the value obtained suggested some effect, albeit not Cat 1 H318, it is likely that the undiluted substance may well have been eye corrosive and thus a precuationary classification of H319 Eye irritant Cat 2 has been applied.
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:
- 2017
- 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)
- Deviations:
- not specified
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Sample details not specified in the report but it is ubderstood that the sample supplied was ColaTeric LAB, which is an aqueous solution of lauryl betaine in water at an active strength of 35%.
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: EpiDerm system - cultured
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 30 microlitres of all articles.
- Duration of treatment / exposure:
- 35 +/- 1 minute @ 37C and then placed in a steril hood until the 60 minute exposure period was reached.
- Duration of post-treatment incubation (if applicable):
- 24 hours +/- 2 hours after washing.
- Number of replicates:
- Three
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 7.8
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Remarks:
- Value is 2.287 and lies between the range of >=0.8 - <=2.8 as per OECD 439
- Positive controls validity:
- valid
- Remarks:
- Value is 7.4% which is <=20% as required by the method
- Remarks on result:
- positive indication of irritation
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Mean value of three test data gave a value of 7.8% mean issue viability in the EpiDerm skin test (OECD 439).
Accoridng to the test protocol, a value of <=50% predicts Irritant GHS Cat 2.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 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 i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- ColaTeric LAB-70UP product was supplied by Colonial for this test.
The lot # was 55880C17.
This product contains lauryl betaine at 35% active strength in water. - Vehicle:
- physiological saline
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- The ColaTeric product was applied at 10% in saline. This infers that the strength of the active that was applied was 3.5%
A volume of 0.75ml was applied uniformly to the bovine cornea under conditions specified in the method. - Duration of treatment / exposure:
- 10 minutes, followed by a minimum of three washes.
- Duration of post- treatment incubation (in vitro):
- 2 hours
- Number of animals or in vitro replicates:
- Three corneas were used per article.
- Irritation parameter:
- in vitro irritation score
- Remarks:
- Mean score for three readings
- Value:
- 30.7
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- Mean in-vitro score = 46.0
- Irritation parameter:
- cornea opacity score
- Remarks:
- Mean score for three results
- Value:
- 12
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- Mean opacity score = 27.3
- Other effects / acceptance of results:
- Acceptance criteria was met as being within 2 standard deviations of the current historical mean at the testing facility.
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Under the conditions of the test, the sample eliicited an average in vitro score of 30.7.
The positive control elicited an average in vitro score of 46.0.
Under the decision cirteria of this test, these values fall within the 'No prdictions can be made' category.
However, since the test sample was only 35% active and the value obtained suggested some effect, albeit not Cat 1 H318, it is likely that the undiluted substance may well have been eye corrosive and thus a precuationary classification of H319 Eye irritant Cat 2 has been applied.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
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.
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