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EC number: 202-462-0 | CAS number: 95-88-5
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Available Data
Data source
Reference
- Reference Type:
- secondary source
- Title:
- OPINION ON 4-Chlororesorcinol, SCCS/1224/09 Revision of 12 July 2010
- Author:
- European Commission Directorate General for Health & Consumers
- Year:
- 2 010
- Bibliographic source:
- Scientific Committee on Consumer Safety (SCCS),
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- Dermal absorption study has been used to estimate the toxico-kinetic potential of the chemical 4-chlororesorcinol
- GLP compliance:
- no
Test material
- Reference substance name:
- 4-chlororesorcinol
- EC Number:
- 202-462-0
- EC Name:
- 4-chlororesorcinol
- Cas Number:
- 95-88-5
- Molecular formula:
- C6H5ClO2
- IUPAC Name:
- 4-chlorobenzene-1,3-diol
- Details on test material:
- CAS NO: 95-88-5
Chemical Name: 4-chlororesorcinol
Nature of the chemical: Organic
Constituent 1
Test animals
- Species:
- other: dermatomed pig skin, 380 μm thickness
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Route of administration:
- dermal
- Vehicle:
- other: hydrogen peroxide & water
- Details on exposure:
- The aqueous solution and formulated material all containing 2.5% w/w of [14C] 4-chlororesorcinol were applied to the dermatomed membranes at a rate of 10mg/cm² and left unoccluded. The
applications were rinsed off after a 0.5h contact period, with the penetration of [14C] 4-chlororesorcinol through the membrane being assessed throughout the entire 48h exposure period. At the end of the exposure period, the distribution of [14C] 4-chlororesorcinol in the test system was assessed, which included a
tape stripping technique to determine its distribution in the skin.
Samples collected during this study were analysed by liquid scintillation counting (LSC). - Duration and frequency of treatment / exposure:
- 48h exposure period
Doses / concentrations
- Remarks:
- Doses / Concentrations:
10 mg/cm²
- No. of animals per sex per dose / concentration:
- Not applicable
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- The dermal penetration of [14C] 4-chlororesorcinol from the cream formulation with and without hydrogen peroxide was low and the vast majority of the dose was recovered in the wash at 0.5h.
After the 0.5h exposure period, the amount which had penetrated was 0.062 μg/cm² (~0.024%) (with hydrogen peroxide) and 0.022 μg/cm² (~0.008%)
(without hydrogen peroxide) and after 48h, the amount penetrated was 1.17 μg/cm² (~0.448%) (with hydrogen peroxide) and 1.69 μg/cm² (~0.651%) (without
hydrogen peroxide). A small proportion of the dose was found adsorbed to the stratum corneum (0.855%) (with hydrogen peroxide) and (0.533%) (without hydrogen peroxide).
For the aqueous solution of [14C] 4-chlororesorcinol, penetration occurred during the whole 48 hour test period giving a penetration rate of 2.03μg/cm²/h during the first 4 hours (for comparison with the cream formulations) and the penetration rate between the 4 and 48h time period was 0.623μg/cm²/h.
At 48h the amount penetrated was 35.8 μg/cm² (~14.2%). 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 20.8% (~52.6μg/cm²) of the topically applied amount. - Details on distribution in tissues:
- Details not available
- Details on excretion:
- Not applicable
Metabolite characterisation studies
- Metabolites identified:
- no
Any other information on results incl. tables
This data demonstrate that the systemic availability, after dermal exposure to[14C] 4-chlororesorcinolfrom formulations would be low especially under normal use conditions in combination with a hydrogen peroxide developer and would be significantly less than that available from a solution of[14C] 4-chlororesorcinolin water. The total recovery of radioactivity was 103% (with hydrogen peroxide) and 107% (without hydrogen peroxide).
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): low bioaccumulation potential based on study results
This data demonstrate that the systemic availability, after dermal exposure to [14C] 4-chlororesorcinol from formulations would be low especially under normal use conditions in combination with a hydrogen peroxide developer and would be significantly less than that available from a solution of [14C] 4-chlororesorcinol in water. The total recovery of radioactivity was 103% (with hydrogen peroxide) and 107% (without hydrogen peroxide). - Executive summary:
The in-vitro study conducted on dermatomed pig skinwith the test chemical[14C] 4-chlororesorcinol dissolved in the vehicle hydrogen peroxide and water indicates low dermal penetration of the test substance. Low absorption of the test chemical by the dermal route can be an indication of low bio-accumulation potential; though and in-vitro study result is insufficient to prove the same.
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