Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 201-325-2 | CAS number: 81-11-8
- 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
Skin sensitisation
Based on the result obtained from the studies available for the structurally similar read across chemicals, it can be concluded that the test chemical cannot cause skin sensitization and thus cannot be considered as skin sensitizing.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- experimental data from various test chemicals
- Justification for type of information:
- Data is summarized based on the available information from various test chemicals.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- WoE report is based on 2 skin sensitization studies as- WoE-2 and WoE-3.
Skin sensitization test was conducted on humans to determine the potential of skin sensitization caused by the chemical. - GLP compliance:
- not specified
- Type of study:
- patch test
- Justification for non-LLNA method:
- not specified
- Species:
- other: Human
- Strain:
- other: not applicable
- Sex:
- not specified
- Details on test animals and environmental conditions:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: soap plus borate solution
- Remarks:
- 2
- Concentration / amount:
- 3% of the test chemical
- Day(s)/duration:
- 21 Days
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: detergent base solution
- Remarks:
- 3
- Concentration / amount:
- The test material (a 0.5% aqueous solution of a detergent mixture containing 10% chemical) was applied.
- Day(s)/duration:
- 3 week
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: soap plus borate
- Remarks:
- 2
- Concentration / amount:
- Not Specifed
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: detergent base solution
- Remarks:
- 3
- Concentration / amount:
- The test material (a 0.5% aqueous solution of a detergent mixture containing 10% chemical) was applied.
- Day(s)/duration:
- 2 weeks after induction
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 2. 72 subjects
3. 70 human subjects - Details on study design:
- 2. No Data Available
3. MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: No data
- Exposure period: 3 week period
- Test groups: No data
- Control group: The vehicle also was applied as a negative control.
- Site: occlusive patches
- Frequency of applications: series of 9 applications
- Duration: 24 hours'
- Concentrations: 0.5% aqueous solution of a detergent mixture containing 10% chemical
B. CHALLENGE EXPOSURE
- No. of exposures: No data
- Day(s) of challenge: Challenge applications were made 2 weeks later.
- Exposure period: No data
- Test groups: No data
- Control group: The vehicle also was applied as a negative control.
- Site: occlusive patches
- Concentrations: 0.5% aqueous solution of a detergent mixture containing 10% chemical - Challenge controls:
- 2. Soap plus borate
3. The vehicle also was applied as a negative control. - Positive control substance(s):
- no
- Remarks:
- No positive control was applied.
- Positive control results:
- No Data Available
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 3% of the test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 72
- Clinical observations:
- No Clinical observations were seen in the subjects.
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- 2
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5%
- No. with + reactions:
- 0
- Total no. in group:
- 70
- Clinical observations:
- No skin sensitization was observed
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- 3
- Interpretation of results:
- other: Not sensitizing
- Conclusions:
- Based on the result obtained from the studies available for the structurally similar read across chemicals, it can be concluded that the test chemical cannot cause skin sensitization and thus cannot be considered as skin sensitizing.
- Executive summary:
The skin sensitization potential was assessed based on the available results from the various test chemicals.These studies have been summarized as below -
A skin sensitization study was performed using the test chemical on human subjects so as to identify the sensitizing potential of the test chemical. The test material (3% of the test chemical in a soap plus borate solution was applied under occlusive patches in a series of 9 applications (each of 24 hours' duration) during a 3 week period to 72 human subjects. Challenge applications were made 2 weeks later. The vehicle also was applied as a negative control. No positive control was applied. The test application sites were graded for primary irritation at various intervals. The material did not appear to cause irritation. None of the subjects were sensitized. Hence, based on all the observations and results, it was concluded that the test chemical was not considered to be sensitizing to the human subject, and is thus not likely to be classified for sensitization as per CLP.
The above study was supported with another skin sensitization study conducted using the given test chemical in humans by patch test. The test chemical (10% brightener in a detergent base solution) was applied under occlusive patches in a series of 9 applications (each of 24 hours' duration) during a 3 week period to 70 human subjects. Challenge applications were made 2 weeks later. The vehicle also was applied as a negative control. No positive control was applied. The detergent base contained sodium alkylbenzenesulfonate, sodium alkyl sulfate, sodium tripolyphosphate, sodium sulfate and minor ingredients including perfumes. Component concentrations were not listed, but were stated as being within ranges of usual commercial formulations. No skin sensitization was observed in this study. Hence, the given test chemical is not likely to be skin sensitizing to the human skin.
Based on the result obtained from the studies available for the structurally similar read across chemicals, it can be considered that the test chemical cannot cause skin sensitization and thus cannot be considered as skin sensitizing.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin sensitization
The skin sensitization potential was assessed based on the available results from the various test chemicals.These studies have been summarized as below -
A skin sensitization study was performed using the test chemical on human subjects so as to identify the sensitizing potential of the test chemical. The test material (3% of the test chemical in a soap plus borate solution was applied under occlusive patches in a series of 9 applications (each of 24 hours' duration) during a 3 week period to 72 human subjects. Challenge applications were made 2 weeks later. The vehicle also was applied as a negative control. No positive control was applied. The test application sites were graded for primary irritation at various intervals. The material did not appear to cause irritation. None of the subjects were sensitized. Hence, based on all the observations and results, it was concluded that the test chemical was not considered to be sensitizing to the human subject, and is thus not likely to be classified for sensitization as per CLP.
The above study was supported with another skin sensitization study conducted using the given test chemical in humans by patch test. The test chemical (10% brightener in a detergent base solution) was applied under occlusive patches in a series of 9 applications (each of 24 hours' duration) during a 3 week period to 70 human subjects. Challenge applications were made 2 weeks later. The vehicle also was applied as a negative control. No positive control was applied. The detergent base contained sodium alkylbenzenesulfonate, sodium alkyl sulfate, sodium tripolyphosphate, sodium sulfate and minor ingredients including perfumes. Component concentrations were not listed, but were stated as being within ranges of usual commercial formulations. No skin sensitization was observed in this study. Hence, the given test chemical is not likely to be skin sensitizing to the human skin.
Based on the result obtained from the studies available for the structurally similar read across chemicals, it can be considered that the test chemical cannot cause skin sensitization and thus cannot be considered as skin sensitizing.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the result obtained from the studies available for the structurally similar read across chemicals, it can be concluded that the test chemical cannot cause skin sensitization and thus cannot be considered as skin sensitizing.
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.