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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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EC number: 200-578-6 | CAS number: 64-17-5
- 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1972
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Citet in OECD SIDS. Acceptable, study with sufficient basic documentation to demonstrate that study meets basic scientific principles and contains enough detail to be able to judge the results reliable as a supporting study.
Data source
Reference
- Reference Type:
- publication
- Title:
- A comparison of rabbit and human skin response to certain irritants.
- Author:
- Phillips, L. II., Steinberg, M., Maibach, H.J., Akers, W.A.
- Year:
- 1 972
- Bibliographic source:
- Toxicol Appl Pharmacol 21:369-382.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Draize protocol
- Deviations:
- yes
- Remarks:
- see below
- Principles of method if other than guideline:
- The test method was a modification of the Draize 1944 protocol to make it suitable for use with humans but using repeated daily occluded applications over a sub-acute period.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Ethanol
- EC Number:
- 200-578-6
- EC Name:
- Ethanol
- Cas Number:
- 64-17-5
- Molecular formula:
- C2H6O
- IUPAC Name:
- ethanol
- Details on test material:
- - Name of test material (as cited in study report): Other TS
- Analytical purity: Test compound was 95% ethanol. It is assumed that this is doubly rectified material, in which case the remainder is 5% water.
Constituent 1
Test animals
- Species:
- human
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.2ml
- Duration of treatment / exposure:
- 21 days or until a grade 4 reaction seen.
- Observation period:
- Readings taken daily when patch removed before re-application of next daily dose.
- Number of animals:
- 2
- Details on study design:
- TEST SITE
- Area of exposure: paraspinal location on subject's back, clipped 24 hours prior to testing
- % coverage: 2x2cm areas, 11 per subject )5 one side, 6 the other
- Type of wrap if used: Patches of non-woven fabric (Webril) impregnated with test material then occluded with Blenderm impermeable tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Scoring done 30 mins after patch removal. Scoring system used was:
0=no reaction
+/- = questionable erythema not covering entire patch
1=definite erythema over whole patch
2=erythema and induration
3=vesiculation
4=bullous reaction
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: cumulative score
- Score:
- 10
- Max. score:
- 80
- Reversibility:
- no data
Any other information on results incl. tables
Daily scores
Days | Score |
1 -12 | 0 |
13, 14 | +/- |
15 -18 | 1 |
19 -21 | 2 |
Applicant's summary and conclusion
- Interpretation of results:
- other: slightly irritating under extreme repeat dose situations
- Remarks:
- Criteria used for interpretation of results: expert judgment
- Conclusions:
- Direct comparison of the results against the EU classification criteria is not possible. There is evidence that under repeat dose exposure skin irritation can eventually occur.
On the other hand - In the form of biocidally active surgical spirit (70-80% ethanol in water), there is a considerable history of dermal application of ethanol as an antiseptic with no concern for skin irritancy. Similarly, large amounts of ethanol are used in a variety of cosmetics, personal care and household cleaning products. - Executive summary:
In a study that was designed to assess the potential for skin irritation under severe repeated dose conditions, ethanol was applied under occlusive conditions to the skin (backs) of male human volunteers. The application was repeated daily and the response checked from the previous dose before each fresh application. No irritation was seen until day 13, after which the irritative response slowly increased, initially as erythema until by day 19 erythema plus induration were also seen. The study was halted on day 21.
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.
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