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EC number: 213-969-1 | CAS number: 1070-10-6
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 1987-09-01 until 1987-09-22
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Guideline study. Read-across justification: The substance is hydrolytically unstable. When it comes in contact with water or moisture complete hydrolysis will take place with no significant reaction products other than alcohol and hydrated titanium dioxide. This rapid hydrolysis (hydrolysis half-life < 3 minutes to < 2 hours) is the driving force for the toxicokinetics of target substance. Because of the rapid hydrolysis, the influence of the mode of administration through inhalation, dermal and oral is related to the hazardous degradation product (alcohol) released from the target substance. The identification of degradation products from the hydrolysis study conducted for the target substance verifies that there are no impurities in the alcohol released from the target substance, which might change the hazardous properties of the target substance compared to the properties of the pure alcohol. As there is a mechanistic reasoning to the read-across, the unnecessary animal testing is avoided by using the read-across data from the degradation product (relevant alcohol) to evaluate irritation, sensitization and the short term and long-term toxicological effects and mutagenicity of the target substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-ethylhexan-1-ol
- EC Number:
- 203-234-3
- EC Name:
- 2-ethylhexan-1-ol
- Cas Number:
- 104-76-7
- Molecular formula:
- C8H18O
- IUPAC Name:
- 2-ethylhexan-1-ol
- Details on test material:
- IUCLID4 Test substance: as prescribed by 1.1 - 1.4
- Analytical purity: 99.5%
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Small Russian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Karl Thomae GmbH, Biberach, Germany
- Weight at study initiation: 2.3 - 2.5 kg
- Housing: singly in stainless steel cages
- Diet: diet K4, Ssniff Spezialfutter GmbH, Soest, Germany, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1°C
- Humidity (%): 60 +/- 5%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 hrs
IN-LIFE DATES: From: day 0 (initiation) To: day 21 after treatment
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eyes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no
SCORING SYSTEM: according to Draize (OECD 405)
TOOL USED TO ASSESS SCORE: fluorescein
EVALUATION:
1) Modified Maximum Average Score (MMAS) according to Draize (1944; cf. ECETOC (1998), company study T01716)
2) Average scores according to EU (79/831/EEC)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: MMAS
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 28.59
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 1.44
- Max. score:
- 2
- Reversibility:
- fully reversible within: 17 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0.89
- Max. score:
- 1
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 2.56
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0.78
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
Any other information on results incl. tables
Read-across justifications and data matrices are presented in IUCLID section 13.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- 2-EH was markedly irritant to the rabbit's eye in a valid OECD 405 test. The effects were fully reversible within 21 days. The mean conjunctivae score (reddening) was 2.56 and exceeded slightly the EU criterion for classification (R36).
- Executive summary:
2-EH was markedly irritant to the rabbit's eye in a valid OECD 405 test using 3 animals. Moderate corneal opacity was seen in all animals at 24 and 48 hours after treatment. The effect was absent in 2 animals at 72 hours after treatment and at 17 days in the third animal. Grade 1 iritis was noted in all animals. The effect was absent in two animals on day 6, and on day 21 in the third animal. Moderate reddening of the conjunctivae was seen in all animals at 24 and 48 hours after treatment. Two animals were free of this effect on day 8, the third on day 21. Chemosis was slight in two animals, and on day 8 all animals were free of this effect.
To conclude, 2-EH caused moderate eye irritation in all 3 treated animals. The effects were fully reversible within 21 days. The MMAS (Mean Modified Average Score) according to Draize was 28.59. The mean conjunctivae score (reddening) was 2.56 and exceeded slightly the EU criterion for classification (R36) (Hüls AG, 1987).
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