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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
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- Flash point
- Auto flammability
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- 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
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- Endpoint summary
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- 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
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- 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
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye 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: 99.72% Lot no: 0901/95-0121
- Storage condition of test material: room temperature in an unlit cabinet
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Ltd., Margate
- Age at study initiation: 13 to 16 weeks
- Weight at study initiation: 2.55 to 2.62 kg
- Housing: individually in floor-pens
- Diet (e.g. ad libitum): SQC TRB Rabbit Diet 9603 (pelleted) from Harlan Teklad, Bicester, available ad libitum
- Water (e.g. ad libitum): Mains water
- Acclimation period: approximately 3 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 to 22
- Humidity (%): 40 to 80
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- Single administration
- Observation period (in vivo):
- 0.5, 1, 4, 24, 48, 72 hours and 7 days after treatment.
- Number of animals or in vitro replicates:
- 3 animals
- Details on study design:
-
SCORING SYSTEM: as in guideline (see attached scoring scale)
TOOL USED TO ASSESS SCORE: Either visually or with a pencil-beam torch or similar to illuminate and magnify the eye. Fluorescein staining was used as considered appropriate with a UV lamp.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- other: reversible in 4 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- other: reversible in 4 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- other: reversible in 4 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- other: reversible in 4 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- other: reversible in 4 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- other: reversible in 4 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- other: reversible in 4 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- other: reversible in 4 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- other: reversible in 4 days
- Irritant / corrosive response data:
- See attached Table 1 for results
Any other information on results incl. tables
No clinical signs of systemic toxicity or ill health were noted for any rabbits during the course of the study. The individual scores for ocular reactions elicited by hexylene glycol are given in Table 1. Instillation of hexylene glycol caused practically no initial sting responses. All rabbits developed corneal and conjunctival irritation within one hour of instillation of the test article. These changes did not exceed diffuse opacity and stippling of the cornea, a crimson appearance of the conjunctivae, chemosis sufficient to cause partial eversion of the eyelids and an ocular discharge. The conjunctival reactions for one rabbit intensified such that four hours after treatment the conjunctivae were crimson, chemosis was sufficient to obscure approximately one-half of the eye and there was a marked ocular discharge. Iridial inflammation was also apparent in this eye at the same examination. On the following day, all rabbits showed diffuse corneal opacity and conjunctival reactions not exceeding a crimson appearance, chemosis sufficient to cause partial eversion of the eyelids and an ocular discharge. Corneal absorption of fluorescein applied to the tear film confirmed disruption of the corneal epithelium. Progressive resolution of the effects of hexylene glycol was apparent from Day 2 and was complete by Day 4 (two rabbits) or Day 8.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Slightly irritating
- Executive summary:
An eye irritation study on hexylene glycol has been performed in accordance with OECD Guidelines for the Testing of Chemicals No. 405 and in compliance with GLP. In this study, 0.1 mL of undiluted hexylene was instilled into one conjunctival sac of each of 3 New Zealand White rabbits. Ocular changes were assessed 0.5, 1, 4, 24, 48, 72 hours, and 7 days after treatment, and scoring was performed according to guideline methods. No clinical signs of systemic toxicity or ill health were observed in any rabbit during the course of the study. Instillation of hexylene glycol caused practically no initial sting responses. All rabbits developed corneal and conjunctival irritation within 1 hour of instillation of the test substance. These changes did not exceed diffuse opacity and stippling of the cornea (a crimson appearance of the conjunctivae), chemosis sufficient to cause partial eversion of the eyelids, or an ocular discharge. The conjunctival reactions in one rabbit intensified such that, four hours after treatment, the conjunctivae were crimson, chemosis was sufficient to obscure approximately one-half of the eye, and a marked ocular discharge was observed. Iridial inflammation also was apparent in this eye at the same examination. On the following day, all rabbits showed diffuse corneal opacity and conjunctival reactions not exceeding a crimson appearance, chemosis sufficient to cause partial eversion of the eyelids, or an ocular discharge. Corneal absorption of fluorescein applied to the tear film confirmed disruption of the corneal epithelium. Progressive resolution of the observed effects was apparent from Day 2 and was complete by Day 4 (in 2 rabbits) or Day 8. Individual mean scores over 14, 48 and 72 hours were 1, 0.7 and 0.7 for cornea opacity, 0, 0 and 0 for iritis, 1, 0.7 and 1 for conjunctival irritation and 1.3, 0.3 and 1 for chemosis. Therefore, a single instillation of hexylene glycol into the conjunctival sac of 3 rabbits caused changes of the cornea, iris, and conjunctivae that resolved within seven days of treatment.
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