Registration Dossier
Registration Dossier
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EC number: 203-961-6 | CAS number: 112-34-5
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study seems to follow main requirements of the OECD protocol although not all information is included in publication to judge if it is followed exactly. :The test substance was not radiolabelled therefore there was no attempt at a mass balance. Not enough raw data reported to meet protocol requirements. Some minor detail of experimental methods also lacking.
Data source
Reference
- Reference Type:
- publication
- Title:
- Absorption of some glycol ethers through human skin in vitro
- Author:
- Dugard PH, Walker M, Mawdsley SJ, Scott RC
- Year:
- 1 984
- Bibliographic source:
- Env Hlth Persp, 57, 193-7
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 428 (Skin Absorption: In Vitro Method)
- Principles of method if other than guideline:
- See comments on reliability.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 2-(2-butoxyethoxy)ethanol
- EC Number:
- 203-961-6
- EC Name:
- 2-(2-butoxyethoxy)ethanol
- Cas Number:
- 112-34-5
- Molecular formula:
- C8H18O3
- IUPAC Name:
- 2-(2-butoxyethoxy)ethanol
- Details on test material:
- - Name of test material (as cited in study report): 2-(2-butoxyethoxy)ethanol, diethylene glycol monobutyl ether, DB
- Physical state: liquid
- Analytical purity: >98%
- Other: Source: ICI Petrochemicals and Plastics division, Wilton, UK
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- human
- Strain:
- other: not applicable
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- no further data on source of skin.
Administration / exposure
- Type of coverage:
- other: not aplicable as study in vitro
- Vehicle:
- unchanged (no vehicle)
- Duration of exposure:
- 8 hours
- Doses:
- Single
- No. of animals per group:
- not applicable
- Control animals:
- no
- Details on study design:
- See other information below.
- Details on in vitro test system (if applicable):
- SKIN PREPARATION
- Source of skin: Obtained post mortem, source unknown.
- Ethical approval if human skin: no data
- Type of skin: Abdominal whole skin
- Preparative technique: Subcutaneous fat removed, then immersed in water (60C, 45 seconds) to allow separation of epidermis. Discs then cut for diffusion cells (1.8cm2 absorption area).
- Membrane integrity check: By following time dependent diffusion of tritiated water before and after exposure to the substance. Skin samples showing a tritiated water permeability greater than 0.0015cm/hr over 6 hours were rejected.
PRINCIPLES OF ASSAY
- Solubility of test substance in receptor fluid: complete
- Static system: Yes
- Test temperature: 30C
Results and discussion
- Signs and symptoms of toxicity:
- not specified
- Remarks:
- not applicable
- Dermal irritation:
- not specified
- Remarks:
- not applicable
- Absorption in different matrices:
- not applicable
- Total recovery:
- not applicable
- Conversion factor human vs. animal skin:
- no data
Any other information on results incl. tables
Applicant's summary and conclusion
- Conclusions:
- skin uptake is unlikely to be a significant route of exposure
- Executive summary:
An in vitro dermal absorption study using human skin showed that 2 -(2 -butoxyethoxy)ethanol is able to pass through the stratum corneum but only at a slow rate (35ug/cm2/hr) and does so without causing any significant detectable damage to the skin. There is a lag time of approximately 2 hours for substance to cross the skin and appear in the receptor fluid
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