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EC number: 236-124-9 | CAS number: 13177-41-8
- 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
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EU method B.40 bis (in vitro skin corrosion: Human skin model test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Frey-Tox GmbH, Osteroda 38, 04916 Herzberg (Elster)
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Control samples:
- yes, concurrent vehicle
- yes, concurrent positive control
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- water
- Controls:
- yes
- Amount / concentration applied:
- 25 mg ± 2.5 mg of the test item were applied together with 25 µL demineralised water
- Duration of treatment / exposure:
- 3 min, 1 h
- Observation period:
- measurement directly following after treatment
- Number of animals:
- 2 replicates of tissue from epidermis skin model EpiDerm
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min
- Value:
- 101.5
- Vehicle controls validity:
- valid
- Negative controls validity:
- not specified
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 h
- Value:
- 105.1
- Vehicle controls validity:
- valid
- Negative controls validity:
- not specified
- Positive controls validity:
- valid
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of the in vitro study the test is classified as non-corrosive according to the OECD guideline 431.
- Executive summary:
Two tissues of the human skin model EpiDermTM were treated with the test substance for 3 minutes and 1 hour, respectively. Demineralised water was used as negative control and 8 M KOH was used as positive control.
After treatment with the negative control, the absorbance values were within the required acceptability criterion. The positive control showed clear corrosive effects for both treatment intervals.
After 3 minutes treatment with the test substance, the mean value of relative tissue viability was increased to 101.5%. This value is above the threshold for corrosion potential (50%). After 1 hour treatment, the mean value of relative tissue viability was increased to 105.1%. This value, too, is above the threshold for corrosion potential (15%).
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
- 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 Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- LAUS GmbH Auf der Schafweide 20 D-67489 Kirrweiler
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Slaughtered cattle that were between 12 and 60 months old
- Vehicle:
- physiological saline
- Controls:
- yes
- Duration of treatment / exposure:
- 1 h
- Observation period (in vivo):
- 4 h
- Number of animals or in vitro replicates:
- 3 bovine corneas were used.
- Irritation parameter:
- in vitro irritation score
- Value:
- 20.7
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Under the conditions of this test, the test item Stearyl Sulfobetaine showed effects on the cornea of the bovine eye. The calculated mean IVIS was 20.70.
According to OECD Guideline no. 437 (Jun. 2020), a substance with an IVIS > 3 and ≤ 55 induces effects on the cornea, that cannot be classified in an UN GHS Category with the BCOP test only. In this case no prediction can be made.
Reference
According to the guideline, the test is considered as valid if the positive control causes an IVIS that falls within two standard deviations of the current historical mean.
The negative or solvent control has to show an IVIS <= 3: 0.71
Values for positive controls were within the range of historical data of the test facility 75.32 -143.16: 104.42
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Justification for classification or non-classification
Although the in vitro test came to a borderline conclusion, the test substance is classified as Skin Irrit. 2, H315: Causes skin irritation and Eye Irrit. 2A, H319: Causes serious eye irritation.as a worst case approach.
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