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Diss Factsheets
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EC number: 203-518-7 | CAS number: 107-75-5
- 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
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable publication/thesis which meets basic scientific principles
Data source
Reference
- Reference Type:
- other: Ph.D. thesis
- Title:
- The Cutaneous Disposition of the Sensitizing Chemicals Hydroxycitronellal and Dinitrochlorobenzene
- Author:
- Tonge, R. P.
- Year:
- 1 995
- Bibliographic source:
- Thesis submitted for Degree of Philosophy in the University of London
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Investigation of the absorption and distribution of Hydroxycitronellal through different layers of rat skin using an in vitro flow-though diffusion cell system.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 7-hydroxycitronellal
- EC Number:
- 203-518-7
- EC Name:
- 7-hydroxycitronellal
- Cas Number:
- 107-75-5
- Molecular formula:
- C10H20O2
- IUPAC Name:
- 7-hydroxy-3,7-dimethyloctanal
- Test material form:
- not specified
- Details on test material:
- HC:
- Name of test material (as cited in study report): 7-Hydroxycitronellal, Hydroxycitronellal or HC
- Provided by Bush Boake Allen Ltd., London, U.K.
- Purity: 98% ('Pure 55' grade)
[14C]HC:
- Specific activity: 200 kBq/mg, 34 Mbq/mmol (5.4 µCi/mg, 930 µCi/mmol)
- Locations of the label: 3,7-Dimethyl-7-hydroxy[7-14C]ocanal
- Purity: 95.3%
- Purchased from Amersham international, Buckinghamshire, England, U.K.
- Storage condition: -20°C
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- [14C]HC (hydroxycitronellal)
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Olac (Oxford, U.K.)
- Weight at study initiation: ca. 200 g
- Diet and Water: ad libitum
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: no vehicle or ethanol or ethanol:DEP (75:25)
- Duration of exposure:
- Absorption of HC through rat skin: up to 72 h
Distribution of HC between the different layers of rat skin: up to 6 h - Doses:
- 4 µL neat HC, 20 µL 20% HC in ethanol or 20 µL 20% HC in ethanol:DEP (mixture of unlabelled and [14C]-labelled HC, each dose contained 1 µCi of radioactivity).
HC neat: 12 mg/cm2
HC 20% in EtOH: 11.16 mg/cm2
HC 20% in EtOH/DEP: 12.59 mg/cm2 - No. of animals per group:
- see "Any other information on materials and methods incl. tables"
- Details on study design:
- DOSE PREPARATION
- Method for preparation of dose suspensions: the stock vial of [14C]HC was diluted appropriately with unlabelled HC and the dose solutions were prepared with or without vehicle. - Details on in vitro test system (if applicable):
- SKIN PREPARATION
- Type of skin: dorsal region of male F344 rats
- Preparative technique: After shaving with animal clippers, the dorsal skin was cut out with dissecting scissors. The skin was placed uppermost on a plastic dissecting board and circles of skin 1.7 cm in diameter cut using a circular steel wad punch. Excess subcutaneous tissue was removed with scissors
- Storage conditions: The skin circles (0.32 cm2) were kept in a petridish on ice for a few minutes until required.
PRINCIPLES OF ASSAY
- Diffusion cell: 6 -14 teflon diffusion cell system with an extra large conical flask, a fraction collector and a peristaltic pump
- Receptor fluid: HEPES buffered Hank's balanced salt solution (HHBSS), pH 7.4
- Flow-through system: yes; Skin circles were placed epidermis side uppermost in the teflon cells and clamped into the cell with the threaded neck. peristaltic pump primed on maximum speed for approximately 3 - 5 min; after this time the pump was set to 1.5 mL/h for the duration of the experiment.
- Test temperature: The skin surface was maintained at 32°C
Results and discussion
Any other information on results incl. tables
1) The absorption of neat HC through full-thickness rat skin and the effect of the vehicle on the absorption:
Neat HC | 20% HC in Ethanol | 20% HC in Ethanol:DEP | ||||
mean % | +/- SD | mean % | +/- SD | mean % | +/- SD | |
Mean culmulative % dose absorbed (receptor fluid) | 30,34 | 7,18 | 28,81 | 5,36 | 33,38 | 4,05 |
Mean % dose skin (dermis/epidermis/stratum corneum) | 33,89 | 9,47 | 31,58 | 5,04 | 27,67 | 8,37 |
Mean % dose swabbed off skin surface | 23,2 | 10,09 | 15,65 | 4,91 | 19,39 | 9,70 |
Mean % dose tape-stripped off skin surface | 3,65 | 1,09 | 3,08 | 1,22 | 1,73 | 0,57 |
Mean % dose on cell body and cell cap | 15,15 | 5,71 | 11,78 | 5,89 | 7,69 | 1,42 |
Mean % dose total recovery | 99,41 | 8,30 | 87,12 | 4,52 | 89,17 | 3,34 |
Sum of % dose receptor fluid + skin | 64 | 60 | 61 | |||
Calculated dose bioavailable* | 53 | 50 | 52 |
Values are from 3 individual experiments with skin from 3 different animals (n=12). skin from a single animal was used for each experiment.
*excluding estimated amount in stratum corneum acc. to ratio of experiment 4:
Mean % dose in receptor fluid + (mean % dose skin *2/3)
For all vehicles examined, no significant differences in the absorption of HC though rat skin were observed.
2) The effect of stratum corneum removal on the absorption of HC through rat skin:
20% HC in Ethanol | 20% HC in Ethanol | |||
Full thickness skin | Tape-stripped skin | |||
mean % | +/- SD | mean % | +/- SD | |
Mean culmulative % dose absorbed (receptor fluid) | 22,4 | 12,44 | 64,34 | 10,17 |
Mean % dose skin (dermis/epidermis/stratum corneum) | 10,69 | 4,72 | 10,39 | 2,06 |
Mean % dose swabbed off skin surface | 42,3 | 10,21 | 21,34 | 9,98 |
Mean % dose tape-stripped off skin surface | 1,09 | 0,21 | 0,45 | 0,12 |
Mean % dose on cell body and cell cap | 11,05 | 7,00 | 4,29 | 2,37 |
Mean % dose total recovery | 87,5 | 3,62 | 100,78 | 11,89 |
Sum of % dose receptor fluid + skin | 33 | 75 | ||
Calculated dose bioavailable* | 30 | n.a. |
Values are from a single experiment with skin from 1 animal (n=3).
*excluding estimated amount in stratum corneum acc. to ratio of experiment 4:
Mean % dose in receptor fluid + (mean % dose skin *2/3)
Compared to full-thickness skin, removal of the stratum corneum resulted in a 3-fold increase in the total amount of HC traversing the skin in 72 hours.
3) The effect of stratum corneum and epidermis removal on the absorption of HC through rat skin:
20% HC in Ethanol | 20% HC in Ethanol | |||
Full thickness skin | Dermatomed skin | |||
mean % | +/- SD | mean % | +/- SD | |
Mean culmulative % dose absorbed (receptor fluid) | 21,56 | 8,21 | 80,48 | 9,79 |
Mean % dose skin (dermis/epidermis/stratum corneum) | 15,46 | 6,60 | 9,51 | 5,96 |
Mean % dose swabbed off skin surface | 41,01 | 5,90 | 0,96 | 0,21 |
Mean % dose tape-stripped off skin surface | 1,5 | 0,33 | 0,06 | 0,02 |
Mean % dose on cell body and cell cap | 7,57 | 2,75 | 1 | 0,57 |
Mean % dose total recovery | 87,53 | 1,28 | 92,01 | 3,13 |
Sum of % dose receptor fluid + skin | 37 | 90 | ||
Calculated dose bioavailable* | 32 | n.a. |
Values are from a single experiment with skin from 1 animal (n=3).
*excluding estimated amount in stratum corneum acc. to ratio of experiment 4:
Mean % dose in receptor fluid + (mean % dose skin *2/3)
Compared to full-thickness skin, dermatomed skin (removal of the stratum corneum and epidermis) resulted in a statistically significant 4-fold increase in the total amount of HC traversing the skin in 72 hours.
4) Distribution of HC between different layers of rat skin:
HC in the stratum corneum rised to a max. level of 5.82 +/- 2.12% at 1h after application and remained approximately constant up to 5.63 +/-1.34% of applied dose at 6h (mean +/-SD, n=12).
HC in remaining skin (dermis/epidermis) rised to a max. level of 7.8 +/- 2.06% at 1h after application and remained approximately constant up to 10.78 +/-4.26% of applied dose at 6h (mean +/-SD, n=12).
No data were given for the amounts HC found in other compartments.
According to these data 1/3 of the amounts HC found in skin are estimated to be located in the SC and 2/3 in epidermis and dermis.
Applicant's summary and conclusion
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