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Diss Factsheets
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EC number: 277-492-0 | CAS number: 73507-17-2
- 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
The test chemical did not induce any allergic response on the human case subjects or animals. Hence the test chemical is not likely to classify as a "skin sensitizer".
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- 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 for the target chemical is summarized based on data from various test chemicals
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- WoE for the target CAS is summarized based on data from various test chemicals
- GLP compliance:
- not specified
- Type of study:
- patch test
- Justification for non-LLNA method:
- Not specified
- Species:
- other: 2/3. Humans; 4. Guinea pigs
- Sex:
- not specified
- Route:
- other: occlusive patches / 2
- Vehicle:
- other: Detergent
- Remarks:
- The detergent formulations used as vehicles contained sodium alkylbenzenesulfonate, sodium alkyl sulfate, sodium tripolyphosphate, sodium sulfate, and minor ingredients including perfumes, but without FWAs.
- Route:
- other: 2
- Concentration / amount:
- The test material (a 0.5% aqueous solution of a detergent mixture containing 10% brightener) was applied.
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Remarks:
- 3
- Concentration / amount:
- 1 mg/mL
- Day(s)/duration:
- 2 days
- Adequacy of induction:
- not specified
- Route:
- other: occlusive patches / 2
- Vehicle:
- other: Detergent
- Remarks:
- the detergent formulations used as vehicles contained sodium alkylbenzenesulfonate, sodium alkyl sulfate, sodium tripolyphosphate, sodium sulfate, and minor ingredients including perfumes, but without FWAs.
- Route:
- other: 2
- Concentration / amount:
- The test material (a 0.5% aqueous solution of a detergent mixture containing 10% brightener) was applied.
- No. of animals per dose:
- 2. 70 human subjects-a 0.5% aqueous solution of a detergent mixture containing 10% brightener
3. 103 female subjects - Challenge controls:
- 2. Challenge applications were made 2 weeks later-other details not available
- 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:
- 2
- Reading:
- 1st reading
- Hours after challenge:
- 0
- Group:
- test chemical
- Dose level:
- 1 mg/mL
- No. with + reactions:
- 0
- Total no. in group:
- 103
- Clinical observations:
- No Clinical observation were seen in any of the subjects.
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- 3
- Interpretation of results:
- not sensitising
- Conclusions:
- The test chemical did not induce any allergic response on the human case subjects or animals. Hence the test chemical is not likely to classify as a "skin sensitizer".
- Executive summary:
Data available for the test chemicals was reviewed to determine the skin sensitization study of the test chemical. The studies are as mentioned below:
In the patch test in humans, the test material (a 0.5% aqueous solution of a detergent mixture containing 10% brightener) 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. No sensitization reaction was observed. The test chemical did not induce any allergic response on the human case subjects. Hence the test chemical is not likely to classify as a "skin sensitizer" .
Another skin sensitization study was also performed using the test chemical on human female subjects so as to identify the sensitizing potential of the test chemical. 103 white females were subjected to ten repeated patch tests (intervals not given) and challenge performed fourteen days after last patch test, totaling eleven applications. A one-half inch square of white blotting paper was impregnated with 1 mg/ml aqueous solution of test material and then was applied on clean back and covered with an "Elastopatch" plaster. The patch was allowed to remain in contact with the skin for forty-eight hours. Upon removal the test areas were observed for immediate reaction. There was no evidence of primary irritation upon removal of the 48 hour patch tests and no indication of sensitization potential on the challenge. Therefore, based on all the observations and results, it was concluded that the test chemical was not found to be sensitizing to the human subject, and is thus likely to be considered as 'Non-Sensitizing' as per CLP.
The skin sensitization study of the test chemical was carried out in guinea pigs to determine its sensitization efficacy. Since the guinea pigs did not elicit any sensitizing effect, the test chemical was considered to be not sensitizing to the skin of guinea pigs and hence it is not likely to classify as a "skin senstizer".
Based on the data available and applying the weight of evidence approach, the test chemical did not induce any allergic response on the human case subjects or animals. Hence the test chemical is not likely to classify as a "skin sensitizer".
Reference
The material did not appear to cause irritation. None of the subjects was sensitized.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Additional information:
Data available for the test chemicals was reviewed to determine the skin sensitization study of the test chemical. The studies are as mentioned below:
In the patch test in humans, the test material (a 0.5% aqueous solution of a detergent mixture containing 10% brightener) 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. No sensitization reaction was observed. The test chemical did not induce any allergic response on the human case subjects. Hence the test chemical is not likely to classify as a "skin sensitizer" .
Another skin sensitization study was also performed using the test chemical on human female subjects so as to identify the sensitizing potential of the test chemical. 103 white females were subjected to ten repeated patch tests (intervals not given) and challenge performed fourteen days after last patch test, totaling eleven applications. A one-half inch square of white blotting paper was impregnated with 1 mg/ml aqueous solution of test material and then was applied on clean back and covered with an "Elastopatch" plaster. The patch was allowed to remain in contact with the skin for forty-eight hours. Upon removal the test areas were observed for immediate reaction. There was no evidence of primary irritation upon removal of the 48 hour patch tests and no indication of sensitization potential on the challenge. Therefore, based on all the observations and results, it was concluded that the test chemical was not found to be sensitizing to the human subject, and is thus likely to be considered as 'Non-Sensitizing' as per CLP.
The skin sensitization study of the test chemical was carried out in guinea pigs to determine its sensitization efficacy. Since the guinea pigs did not elicit any sensitizing effect, the test chemical was considered to be not sensitizing to the skin of guinea pigs and hence it is not likely to classify as a "skin senstizer".
Based on the data available and applying the weight of evidence approach, the test chemical did not induce any allergic response on the human case subjects or animals. Hence the test chemical is not likely to classify as a "skin sensitizer".
Justification for classification or non-classification
Based on the data available and applying the weight of evidence approach, the test chemical did not induce any allergic response on the human case subjects or animals. Hence the test chemical is not likely to classify as a "skin sensitizer".
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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