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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 280-622-9 | CAS number: 83732-72-3
- 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
Additional toxicological data
Administrative data
- Endpoint:
- additional toxicological information
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 22.04. - 02.06.2005
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
- Type of study / information:
- Type: In vitro penetration from three different Vehicles through pig skin
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 428
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reference substance 002
- Cas Number:
- 90817-34-8
- Test material form:
- solid
Constituent 1
Results and discussion
Applicant's summary and conclusion
- Conclusions:
- 1. The vast majority of the applied A 130 in the cream formulations was removed after a contact period of 0.5h by gently washing the skin with a mild detergent solution (101%from the formulation with hydrogen peroxide, 96.6% from the formulation without hydrogen peroxide and 95.6% was washed off the skin from the aqueous solution).
2. Less than 0.6% of the A 130 applied remained in the stratum corneum at the end of the study from the cream applications and less than 0.5% was found in the stratum corneum following the aqueous application.
3. After washing and tape stripping, less than 1.4% of the A 130 applied was found in the remaining epidermis/dermis from the cream applications and less than 0.5% was found in the remaining epidermis/dermis following the aqueous application.
4. Less than 0.8% and less than 1.6% had penetrated through the skin into the receptor fluid from the cream formulations, with and without hydrogen peroxide respectively, at the end of the 48h sampling period. Less than 0.5% penetrated through the skin into the receptor fluid from the aqueous application at the end of the 48h sampling period.
5. The systemically available dose for the cream formulations with and without hydrogen peroxide and the aqueous solution would be approximately 1.72%, 2.94% and 0.881% of the applied dose, respectively. These respective amounts expressed in µg/cm2 are 3.87µg/cm2, 6.62µg/cm2 and 1.99µg/cm2. Therefore, these calculated amounts could be used for risk assessments.
6. The results obtained in this study demonstrate that the penetration of A 130, from these formulations, through dermatomed pig skin is considered to be very slow.
7. These data demonstrate that the systemic availability, after dermal exposure to A 130 from two realistic formulations, would be low especially under normal use conditions in combination with a hydrogen peroxide developer. - Executive summary:
1. Summary
1.1 Study design
The penetration of A 130 has been measured in vitro through dermatomed pig skin from a standard cream formulation (with and without hydrogen peroxide) and from a solution in water. The aqueous solution and formulated material, all containing a nominal 1.13% w/w A 130, were applied to the dermatomed membranes at a nominal rate of 20mg/cm2 or 20µl/cm2 and left unoccluded. The applications were rinsed off after a 0.5h contact period, with the penetration of A 130 through the membrane being assessed throughout the entire 48h exposure period. At the end of the exposure period, the distribution of A 130 in the test system was assessed, which included a tape stripping technique to determine its distribution in the skin.
The applications and exposure conditions were designed to simulate potential human dermal exposure to the formulation during normal use and compare the penetration of A 130 from a standard formulation (with and without hydrogen peroxide) with the penetration from an aqueous solution.
Samples collected during this study were analysed by liquid scintillation counting (LSC).
1.2 Results
1.2.1 A 130 cream formulation with hydrogen peroxide
The dermal penetration of A 130 from this application was low and the vast majority of the dose was recovered in the wash at 0.5h. After 0.5h exposure, the amount which had penetrated the dermatomed pig skin was 0.316µg/cm² (≡0.140%) and after 48h the amount penetrated was 1.59µg/cm² (≡0.707%). Most of the penetration occurred during the first 2 hours giving a penetration rate of 0.596µg/cm²/h. After 2h, the penetration rate remained relatively constant at 0.007µg/cm²/h indicating that the penetration process was essentially complete. The penetration rate over the 0–48h exposure period was 0.022µg/cm²/h. A small proportion of the dose was found adsorbed to the stratum corneum and absorbed in the remaining epidermis/dermis. The overall quantity found to be bioavailable (absorbed and penetrated) within 48 hours under the given study conditions was calculated to be 1.72% (≡ 3.87µg/cm²) of the topically applied amount. The total recovery for this application was 105%.
1.2.2 A 130 cream formulation without hydrogen peroxide
The dermal penetration of A 130 from this application was low and the vast majority of the dose was recovered in the wash at 0.5h. After 0.5h exposure, the amount which had penetrated the dermatomed pig skin was 0.730µg/cm² (≡0.324%) and after 48h the amount penetrated was 3.54µg/cm² (≡1.57%). Most of the penetration occurred during the first 2 hours giving a penetration rate of 1.47µg/cm²/h. After 2h, the penetration rate remained relatively constant at 0.009µg/cm²/h indicating that the penetration process was essentially complete. The penetration rate over the 0–48h exposure period was 0.045µg/cm²/h. A small proportion of the dose was found adsorbed to the stratum corneum and absorbed in the remaining epidermis/dermis. The overall quantity found to be bioavailable (absorbed and penetrated) within 48 hours under the given study conditions was calculated to be 2.94% (≡ 6.62µg/cm²) of the topically applied amount. The total recovery for this application was 101%.
1.2.3 A 130 aqueous solution
The results for one diffusion cell have not been included in the results, as the data indicated that the skin membrane had been damaged during the 0.5h decontamination process.
The dermal penetration of A 130 from this application was low and the vast majority of the dose was recovered in the wash at 0.5h. After 0.5h exposure, the amount which had penetrated the dermatomed pig skin was 0.149µg/cm² (≡0.066%) and after 48h the amount penetrated was 1.00µg/cm² (≡0.444%). Most of the penetration occurred during the first 4 hours giving a penetration rate of 0.192µg/cm²/h. After 4h, the penetration rate remained relatively constant at 0.005µg/cm²/h indicating that the penetration process was essentially complete. The penetration rate over the 0–48h exposure period was 0.015µg/cm²/h. A small proportion of the dose was found adsorbed to the stratum corneum and absorbed in the remaining epidermis/dermis. The overall quantity found to be bioavailable (absorbed and penetrated) within 48 hours under the given study conditions was calculated to be 0.881% (≡ 1.99µg/cm²) of the topically applied amount. The total recovery for this application was 97.6%.
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.