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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-585-2 | CAS number: 108-46-3
- 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
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD/GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 428 (Skin Absorption: In Vitro Method)
- Version / remarks:
- ; OECD Environmental Health and Safety Publications Series on Testing and Assessment No. 28. Guidance Document for the Conduct of Skin Absorption Studies (2004); Basic Criteria for the In Vitro Assessment of Percutaneous Absorption of Cosmetic Ingredients
- GLP compliance:
- yes
Test material
- Reference substance name:
- Resorcinol
- EC Number:
- 203-585-2
- EC Name:
- Resorcinol
- Cas Number:
- 108-46-3
- Molecular formula:
- C6H6O2
- IUPAC Name:
- resorcinol
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- [U-14C]-Resorcinol
Test animals
- Species:
- other: human split-thickness skin membranes
Administration / exposure
- Duration of exposure:
- 0.5 hours then wash, samples taken at 24 hrs post-exposure.
- Doses:
- Actual Resorcinol concentration in formulation (% w/w): 2.55 (Oxidative); 2.52 (Non Oxidative).
Actual Resorcinol concentration in Test Preparation (% w/w): 1.26 (Oxidative); 1.27 (Non Oxidative).
Actual application rate of Test Preparation (mg/m3): 21.08 (Oxidative); 20.07 (Non Oxidative). - Details on study design:
- The study was conducted according to the OECD principles of Good Laboratory Practice and was performed following the SCCNFP, COLIPA and draft OECD guideline for skin penetration studies and the OECD guidance document.
Results and discussion
- Total recovery:
- Absorption Study – Oxidative Test Preparation
The total recovery, dislodgeable dose, unabsorbed dose, absorbed dose and dermal delivery were 252.02, 248.92, 250.97, 0.84 and 1.04 μg
equiv./cm2, respectively.
Absorption Study – Non Oxidative Test Preparation
The total recovery, dislodgeable dose, unabsorbed dose, absorbed dose and dermal delivery were 249.57, 242.65, 246.62, 2.10 and 2.95 μg
equiv./cm2, respectively.
Percutaneous absorptionopen allclose all
- Dose:
- 1.26%
- Parameter:
- percentage
- Absorption:
- 0.32 %
- Remarks on result:
- other: 24 hours
- Remarks:
- oxidative
- Dose:
- 1.27%
- Parameter:
- percentage
- Absorption:
- 0.82 %
- Remarks on result:
- other: 24 hours
- Remarks:
- non-oxidative
Any other information on results incl. tables
Absorption Study – Oxidative Test Preparation
A total of 10 samples of human skin obtained from 5 different donors were dosed topically with [14C]-Resorcinol in the oxidative test preparation of a hair dye formulation (1.25%, w/w). Cells 6, 8, and 13 were rejected from the mean and standard deviation (SD) values due to low mass balance
(outwith 100 ± 10%). The dosing regime for the cells meant that on the first dosing occasion Cell 13 was the last of the cells to be dosed. On the s
econd dosing occasion Cells 6 and 8 were the last two of the cells to be dosed. Bubbles were noted in the pipette tip at the time of dosing these cells. Therefore, the following results are provided as mean values (n = 7).
The mean total recovery was 98.56% of the applied dose at 24 h post dose. At the end of the 0.5 h exposure period, 96.98% of the applied dose was removed during the washing process (95.35% in the 0.5 h skin wash, 1.38 % in the 0.5 h tissue swab and 0.25% in the pipette tips).
At 24 h post dose, ie after a 23.5 h monitoring period, 0.01% of the applied dose was removed from the skin in the 24 h tissue swab. The cell wash
contained 0.37% of the applied dose. Therefore at 24 h post dose, the dislodgeable dose was 97.35% of the applied dose. The total unabsorbed dose was 98.16% of the applied dose. This consisted of the dislodgeable dose and the radioactivity associated with the stratum corneum (0.79%) and unexposed skin (0.02%). Those amounts retained by the stratum corneum and unexposed skin at 24 h are not considered to be dermally absorbed and thus do not contribute to the systemic dose. The absorbed dose (0.32%) was made up from the receptor fluid (0.32%) and the receptor rinse (<0.01%). Dermal delivery (0.40%) was made up from the absorbed dose and exposed skin (0.08%).
The total recovery, dislodgeable dose, unabsorbed dose, absorbed dose and dermal delivery were 252.02, 248.92, 250.97, 0.84 and 1.04 μg
equiv./cm2, respectively.
The lag time and steady state flux could not be accurately determined since the test preparation was removed from the skin surface at 30 min post
dose.
The data shows that [14C]-Resorcinol in oxidative test preparation was effectively removed from the skin surface by the washing procedure
employed.
Absorption Study – Non Oxidative Test Preparation
A total of 12 samples of human skin obtained from 4 different donors were dosed topically with of [14C]-Resorcinol in the non oxidative test
preparation after the addition of water (1.25% w/w). None of the cells were rejected. The following results are provided as mean values (n = 12).
The mean total recovery was 97.44% of the applied dose at 24 h post dose.
At the end of the 0.5 h exposure period, 94.05% of the applied dose was removed during the washing procedure (91.58% in the 0.5 h skin wash, 2.22% in the 0.5 h tissue swab and 0.25% in the pipette tips).
At 24 h post dose, ie after a 23.5 h monitoring period, 0.12% of the applied dose was removed from the skin in the 24 h tissue swab. The cell wash
contained 0.56% of the applied dose. Therefore at 24 h post dose, the dislodgeable dose was 94.73% of the applied dose. The total unabsorbed dose was 96.29% of the applied dose. This consisted of the dislodgeable dose and the radioactivity associated with the stratum corneum (1.50%) and unexposed skin (0.06%). The absorbed dose (0.82%) was made up from the receptor fluid (0.81%) and the receptor rinse (<0.01%). Dermal delivery (1.16%) was made up from the absorbed dose and exposed skin (0.33%).
The total recovery, dislodgeable dose, unabsorbed dose, absorbed dose and dermal delivery were 249.57, 242.65, 246.62, 2.10 and 2.95 μg
equiv./cm2, respectively.
The lag time and steady state flux could not be accurately determined since the test preparation was removed from the skin surface at 30 min post
dose.
The data shows that [14C]-Resorcinol in non oxidative test preparation was effectivelyremoved from the skin surface by the washing procedure
employed.
A summary of the mean results is provided in the table below.
Formulation/Test Preparation |
Oxidative |
Non Oxidative |
Target Resorcinol Concentration in Formulation (%, w/w) |
2.50 |
2.50 |
Actual Resorcinol Concentration in Formulation (%, w/w) |
2.55 |
2.52 |
Target Resorcinol Concentration in Test Preparation (%, w/w) |
1.25 |
1.25 |
Actual Resorcinol Concentration in Test Preparation (%, w/w) |
1.26 |
1.27 |
Target application rate of Test Preparation (mg/m2) |
20.00 |
20.00 |
Actual application rate of Test Preparation (mg/m2) |
21.08 |
20.07 |
Resorcinol (% Applied Dose) |
Mean ± SD |
|
Dislodgeable Dose |
97.35 ± 5.47 |
94.73 ± 1.97 |
Unabsorbed Dose * |
98.16 ± 5.19 |
96.29 ± 1.58 |
Absorbed Dose ** |
0.32 ± 0.14 |
0.82 ± 0.66 |
Dermal Delivery *** |
0.40 ± 0.18 |
1.16 ± 0.88 |
Mass Balance |
98.56 ± 5.10 |
97.44 ± 1.47 |
Resorcinol ( µg equiv/cm2) |
Mean ± SD |
|
Dislodgeable Dose |
248.92 ± 19.87 |
242.65 ± 7.16 |
Unabsorbed Dose * |
250.97 ± 19.59 |
246.62 ± 5.90 |
Absorbed Dose ** |
0.84 ± 0.39 |
2.10 ± 1.67 |
Dermal Delivery *** |
1.04 ± 0.51 |
2.95 ± 2.22 |
Mass Balance |
252.02 ± 19.69 |
249.57 ± 5.12 |
* Unabsorbed dose = dislodgeable dose + stratum corneum + unexposed skin
** Absorbed dose = receptor fluid + receptor rinse
*** Dermal Delivery = exposed skin (except stratum corneum) + absorbed dose
Applicant's summary and conclusion
- Conclusions:
- In conclusion, [14C]-Resorcinol in oxidative and non oxidative test preparations was applied topically to human skin in vitro. Under the present
experimental conditions, for [14C]-Resorcinol in the oxidative test preparation, most of the applied dose was removed at 30 min post dose (96.98%
of the applied dose). At 24 h post dose, a further 0.37% was removed; therefore, the dislodgeable dose was 97.35% of the applied dose. At 24 h post
dose, the absorbed dose and dermal delivery were 0.32% (0.84 μg equiv/cm2) and 0.40% (1.04 μg equiv/cm2) of the applied dose, respectively.
Under the present experimental conditions, for [14C]-Resorcinol in the non oxidative test preparation, most of the applied dose was removed at 30
min post dose (94.05% of the applied dose). At 24 h post dose, a further 0.68% was removed; therefore, the dislodgeable dose was 94.73% of the
applied dose. At 24 h post dose, the absorbed dose and dermal delivery were 0.82% (2.10 μg equiv/cm2) and 1.16% (2.95 μg equiv/cm2) of the
applied dose, respectively. The dermal absorption figure to be taken into consideration for the calculation of the margin of safety is 1.04 μg
equiv./cm2 for the oxidative test preparation and 2.95 μg equiv./cm2 for the non oxidative test preparation.
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.