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Diss Factsheets
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EC number: 203-489-0 | CAS number: 107-41-5
- 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:
- 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-methylpentane-2,4-diol
- EC Number:
- 203-489-0
- EC Name:
- 2-methylpentane-2,4-diol
- Cas Number:
- 107-41-5
- Molecular formula:
- C6H14O2
- IUPAC Name:
- 2-methylpentane-2,4-diol
- Details on test material:
- - Name of test material (as cited in study report): HEXYLENE GLYCOL
- Physical state: liquid
- Analytical purity: 99.66%
- Lot/batch No.: G 09770
- Expiration date of the lot/batch: June 1995
- Storage condition of test material: Room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Interfauna U.K. Ltd., Huntingdon, Cambridgeshire, England.
- Age at study initiation: approximately 11 to 12 weeks of age
- Weight at study initiation: range of 2.6 to 2.9 kg
- Housing: Individually housed in plastic cages with perforated floors
- Diet (e.g. ad libitum): standard laboratory diet SDS Stanrab (P) Rabbit diet ad libitum
- Water (e.g. ad libitum): drinking water ad libitum
- Acclimation period: Rabbits were reported to be acclimated, but number of days not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 19°C
- Humidity (%): 30 - 70%
- Air changes (per hr): approximately 19 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1 hour after removal of test substance and thereafter 24, 48, and 72 hours after exposure. Additional observations were made on Day 5 for one animal.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: dorso-lumbar region
- % coverage: not reported
- Type of wrap if used: Each treatment site was covered with "Elastoplast" elastic adhesive dressing.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treatment site was washed with warm water (30° to 40°C) to remove any residual test substance .
- Time after start of exposure: 4 hours
SCORING SYSTEM: Local dermal irritation was assessed using the prescribed numerical system
Erythema and eschar formation:
No erythema 0
Very slight erythema (barely perceptible) ' 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation
(injuries in depth) preventing erythema reading 4
Oedema formation:
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (raised approximately 1 millimetre) 3
Severe oedema (raised more than 1 millimetre and extending
beyond the area of exposure) 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- DERMAL RESPONSES
Very slight transient erythema was seen in two animals. The skin was normal in one of these animals on Day 3 and in the other on Day 5. The third rabbit showed no dermal response to treatment with HEXYLENE GLYCOL PURE. - Other effects:
- CLINICAL SIGNS
There were no signs of toxicity or ill health in any rabbit during the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- slightly irritation
- Conclusions:
- A single semi-occlusive application of HEXYLENE GLYCOL PURE to intact rabbit skin for four hours elicited very slight transient dermal irritation.
- Executive summary:
A skin irritation study on hexylene glycol has been performed in accordance with OECD Guidelines for the Testing of Chemicals No. 404 and in compliance with GLP. In this study, 3 New Zealand White rabbits were exposed to 0.5 mL of undiluted hexylene on the clipped dorsal lumbar region under semi-occlusive conditions. Animals were exposed to the test compound for 4 hours and observations were recorded at 1, 24, 48, and 72 hours after removal of the patch and residual test substance. Additional observations were made on Day 5 for one animal. Skin reactions were scored according to a prescribed numerical system. Very slight transient erythema was observed in 2 animals, and was fully reversible by Day 3 in one animal and by Day 5 in the other. The third rabbit did not display any dermal reactions. In addition, no signs of toxicity or ill health were observed in any rabbit during the observational period. Individual mean scores over 24, 48 and 72h were 1, 0.7 and 0.7 for erythema and 0, 0 and 0 for oedema. Based on the results of this study, hexylene glycol elicited very slight transient dermal irritation to intact rabbit skin.
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