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EC number: 205-550-7 | CAS number: 142-62-1
- 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 vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 Dec 2011 - 24 Jan 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline Study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 437: Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants (adopted 7 Sept 2009)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- BAYERISCHES LANDESAMT FÜR GESUNDHEIT UND LEBENSMITTELSICHERHEIT, LANDESINSTITUT FÜR ARBEITSSCHUTZ UND PRODUKTSICHERHEIT, München, Germany
Test material
- Reference substance name:
- Hexanoic acid
- EC Number:
- 205-550-7
- EC Name:
- Hexanoic acid
- Cas Number:
- 142-62-1
- Molecular formula:
- C6H12O2
- IUPAC Name:
- hexanoic acid
Constituent 1
Test animals / tissue source
- Species:
- other: cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- IDENTIFICATION OF THE SOURCE OF THE EYES, STORAGE AND TRANSPORT CONDITIONS
- Source: Attenberger Fleisch GmbH & Co. KG, Munich, Germany
- Date of eye collection: 14 Dec 2011
- Transport medium and temperature conditions: Hanks´ Balanced Salt Solution (HBSS) containing penicillin/streptomycin on ice
PREPARATION OF THE EYES (BEFORE EXPOSURE)
- Eyes free of defects (scratches, neovascularisation): yes
- Dissection of the eyes and treatment: Corneas were dissected with a 2 to 3 mm rim of sclera. Isolated corneas were mounted in cornea holders.
- Type of cornea holder used: MC2, Clermont, France
- Description of the cornea holder: the cornea holders consist of an anterior and a posterior compartment, which interface with the epithelial and endothelial sides of the cornea.
- Test medium and temperature conditions used in the cornea holder: RPMI 1640 without phenol red supplemented with 1% [v/v] fetal bovine serum and 2 mM L-glutamine
- Equilibration time: 1 h at 32 ± 1 °C in a water bath
- Quality check of the equilibrated corneas: initial opacity measurement; corneas with an initial opacity above 7 in the opacitometer were discarded.
DETERMINATION OF THE INITIAL OPACITY
- Method: Corneal opacity was determined by the amount of light transmission through the cornea via an opacitometer.
- Specification of the device: MC2, Clermont, France
Test system
- Vehicle:
- other: sesame oil
- Controls:
- other: 3 eyes each for the two negative controls (sesame oil and physiological saline 0.9% NaCl); 3 eyes for the positive control (70% ethanol)
- Amount / concentration applied:
- - Amount(s) applied in the test: 750 µL
- Concentration (if solution): 50% - Duration of treatment / exposure:
- 10 min at 32 ± 1 °C
- Observation period (in vivo):
- not applicable
- Number of animals or in vitro replicates:
- 3 eyes for the test item
- Details on study design:
- TEST CONDITIONS
- Short description of the method used: closed-chamber method.
The test substance or control substances were introduced into the anterior.
POST-EXPOSURE TREATMENT
- Removal of the test substance: Example: The test substance was removed after 10 min incubation and the epithelium washed at least three times. for the corneas treated with sesame oil as vehicle, the chambers were opened and the corneas were rinsed with 100 mL MEM.
- Medium for washing the corneas: MEM containing phenol red
- Medium for final rinsing: Example: RPMI 1640 without phenol red
DETERMINATION OF THE FINAL OPACITY
- Method: Corneal opacity was determined by the amount of light transmission through the cornea via an opacitometer.
- Time of determination: After refilling fresh RPMI 1640 without phenol red into the anterior chamber, the final opacity was measured after 2 hours incubation at 32 ± 1 °C
- Specification of the device: MC2, Clermont, France
DETERMINATION OF THE CORNEAL PERMEABILITY:
- Method: Sodium fluorescein solution was added to the anterior chamber of the cornea holder while the posterior chamber was filled with fresh medium. The amount of sodium fluorescein that crosses into the posterior chamber was quantitatively measured via UV/VIS spectrophotometry at 490 nm recorded as optical density (OD490).
- Amount and concentration of the dye: 1 mL sodium fluorescein solution (4 mg/mL)
- Incubation time: 90 min at 32 ± 1 °C
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- in vitro irritation score
- Remarks:
- mean of all 3 eyes
- Run / experiment:
- 10 min exposure with the test substance
- Value:
- 143.61
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks:
- 62.51
- Irritation parameter:
- other: opacity
- Remarks:
- mean of all 3 eyes
- Run / experiment:
- 10 min exposure with the test substance
- Value:
- 114
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks:
- 52.67
- Irritation parameter:
- other: permeability
- Remarks:
- mean of all 3 eyes
- Run / experiment:
- 10 min exposure with the test substance
- Value:
- 1.974
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks:
- 0.656
- Other effects / acceptance of results:
- For hexanoic acid at a concenration of 50% (v/v) an in vitro irritation score of 143.61 was calculated and therefore the test substance is considered as severe eye irritant.
Any other information on results incl. tables
Table 1: Opacity values
Parameter |
Initial opacity |
Final opacity |
Opacity change |
Mean opacity change of NC |
Corrected opacity change |
Mean opacity value |
Negative control (0.9% NaCl) |
4 |
5 |
1 |
2.33 |
- |
- |
4 |
9 |
5 |
||||
4 |
5 |
1 |
||||
Negative control (sesame oil) |
4 |
7 |
3 |
2.33 |
- |
- |
4 |
5 |
1 |
||||
5 |
8 |
3 |
||||
Test substance |
3 |
124 |
121 |
- |
118.67 |
114.00 |
3 |
112 |
109 |
106.67 |
|||
3 |
122 |
119 |
116.67 |
|||
Positive control |
5 |
56 |
51 |
- |
48.67 |
52.67 |
5 |
58 |
53 |
50.67 |
|||
5 |
66 |
61 |
58.67 |
Table 2: Permeability values (optical density (OD) at 490 nm)
Parameter |
OD490 change |
Mean OD490 change of NC |
Corrected OD490 change |
Mean OD490 value |
Negative control (0.9% NaCl) |
0.003 |
0.004 |
- |
- |
0.009 |
||||
0.001 |
||||
Negative control (sesame oil) |
0.000 |
0.004 |
- |
- |
0.003 |
||||
0.008 |
||||
Test substance |
1.842 |
1.977 |
1.838 |
1.974 |
2.086 |
2.082 |
|||
2.004 |
2.00 |
|||
Positive control |
0.400 |
0.661 |
0.396 |
0.656 |
0.770 |
0.766 |
|||
0.812 |
0.808 |
Table 3: In Vitro Irritancy Score (IVIS) values
|
IVIS |
Mean IVIS |
Negative control (0.9% NaCl) |
1.05 |
2.40 |
5.14 |
||
1.02 |
||
Negative control (sesame oil) |
3.00 |
2.39 |
1.05 |
||
3.12 |
||
Test substance |
146.24 |
143.61 |
137.90 |
||
146.67 |
||
Positive control |
54.61 |
62.51 |
62.16 |
||
70.79 |
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- CLP: Cat. 1, H318
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