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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 950-170-3 | CAS number: -
- 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
Specific investigations: other studies
Administrative data
Link to relevant study record(s)
- Endpoint:
- specific investigations: other studies
- Remarks:
- dermal sensitization
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 8 October 2018 to 16 November 2018
- Type of method:
- other: clinical
- Endpoint addressed:
- skin irritation / corrosion
- skin sensitisation
- Specific details on test material used for the study:
- 2.5% in EtOH/DEP (1:3 w/w)
- Route of administration:
- dermal
- Vehicle:
- other: EtOH/DEP at 1:3 w/w
- Details on exposure:
- The study consisted of an induction phase, a challenge phase, and, at the discretion of the Principal Investigator and at the approval of the Sponsor, a Re-Challenge Test. During the Induction Phase, the test materials were applied to the same location on the back of each subject three times per week for a total of nine applications, with 24-hour rest periods, except Fridays, in between applications, or as specified in Section 10.0. Test sites were examined for dermal irritation at each visit prior to reapplication of the test materials. Approximately 10 to 21 days after the Induction Phase, subjects returned to the laboratory for the Challenge Phase. The test materials were applied to virgin sites on the back under the appropriate patch type, and were removed by clinic staff approximately 24 hours later. Test sites were examined for signs of dermal irritation or sensitization. At the discretion of the Principal Investigator and with the Sponsor’s approval, a subject may have been required to return to the lab for a Re-Challenge Test if reactions indicative of sensitization were observed during the Challenge Phase. During the Re-Challenge Phase, the test material was applied to a virgin site on the upper arm or back under the same conditions of the Challenge Phase and the subject was examined for dermal reactions. At the Sponsor’s request, additional products (“omission products” or individual components) may have been tested and/or other conditions may have been used.
- Analytical verification of doses or concentrations:
- no
- Details on results:
- This study was initiated with 112 subjects. Six subjects discontinued study participation for reasons unrelated to the test material. A total of 106 subjects completed the study.
No adverse events were reported during the study. - Conclusions:
- Based on the test population of 106 subjects and under the conditions of this study, the test materials PG-RAW-0004 at 2.5% in EtOH/DEP (1:3 w/w) did not demonstrate a potential for eliciting dermal irritation or sensitization under the following test conditions: 0.15ml of the test material applied to a 3.63 cm2 occlusive patch, which was equivalent to dermal dosage of approximately 1030 ug/cm2.
- Executive summary:
One hundred and twelve subjects participated in evaluating the potential of PG-RAW-0004 (2.5% in EtOH/DEP 1:3w/w) to elicit dermal irritation and/or induce sensitization. The test material was applied under occlusive patch to the upper back of each subject and were allowed to remain in direct skin contact for a period of 24 hours. Patches were applied to the same site on Monday, Wednesday, and Friday for a total of 9 applications during the Induction Period. The sites were graded by a CRL technician for dermal irritation 24 hours after removal of the patches by the subjects on Tuesday and Thursday and 48 hours after removal of the patches on Saturday.
Approximately 10 to 21 days after the Induction Phase, challenge patches were applied to previously untreated test sites on the back. After 24 hours, the patches were removed by a CRL technician and the test sites were evaluated for dermal reactions. The test sites were re-evaluated at 48 and 72 hours after application. Subjects exhibiting reactions during the Challenge Phase of the study may have been asked to return for a 96-hour reading.
One hundred and six subjects completed the study. The test material identified as PG-RAW-0004 (2.5% in EtOH/DEP 1:3w/w) did not demonstrate a potential for eliciting dermal irritation or sensitization under the following test conditions: 0.15ml of the test material applied to a 3.63 cm2 occlusive patch, which was equivalent to dermal dosage of approximately 1030 ug/cm2.
Reference
Description of key information
One hundred and twelve subjects participated in evaluating the potential of PG-RAW-0004 (2.5% in EtOH/DEP 1:3w/w) to elicit dermal irritation and/or induce sensitization. The test material was applied under occlusive patch to the upper back of each subject and were allowed to remain in direct skin contact for a period of 24 hours. Patches were applied to the same site on Monday, Wednesday, and Friday for a total of 9 applications during the Induction Period. The sites were graded by a CRL technician for dermal irritation 24 hours after removal of the patches by the subjects on Tuesday and Thursday and 48 hours after removal of the patches on Saturday.
Approximately 10 to 21 days after the Induction Phase, challenge patches were applied to previously untreated test sites on the back. After 24 hours, the patches were removed by a CRL technician and the test sites were evaluated for dermal reactions. The test sites were re-evaluated at 48 and 72 hours after application. Subjects exhibiting reactions during the Challenge Phase of the study may have been asked to return for a 96-hour reading.
One hundred and six subjects completed the study. The test material identified as PG-RAW-0004 (2.5% in EtOH/DEP 1:3w/w) did not demonstrate a potential for eliciting dermal irritation or sensitization under the following test conditions: 0.15ml of the test material applied to a 3.63 cm2 occlusive patch, which was equivalent to dermal dosage of approximately 1030 ug/cm2.
Additional information
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.