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EC number: 203-385-5 | CAS number: 106-32-1
- 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 vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11.09.2000 - 15.09.2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
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)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Ethyl octanoate
- EC Number:
- 203-385-5
- EC Name:
- Ethyl octanoate
- Cas Number:
- 106-32-1
- Molecular formula:
- C10H20O2
- IUPAC Name:
- ethyl octanoate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: SPF albino rabbits of the stock Chbb:HM(SPF) - Littlerussian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.3 - 2.8 kg b.w.
- Housing: During a pre-period of at least one week and throughout the experiment the rabbits were caged individually in PPO cages (floor area: 2576 sq.cm) with perforated floor.
- Diet: pelleted complete rabbit diet "Altromin 2123", ad libitum
- Water: ad libitum, domestic quality drinking water acidified with hydrochloric acid to pH 2.5 to prevent microbial growth
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 55% + 15%
- Air changes (per hr): 10 times/hour
- Photoperiod (hrs dark / hrs light): Light was on from 6 a.m. to 6 p.m..
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- - Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 1, 24, 48, and 72 hours
- Number of animals or in vitro replicates:
- 4
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing : 20 ml 0.9% sodium chloride solution
- Time after start of exposure: 24 hours
SCORING SYSTEM: See 'Any other information on materials and methods'
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.3
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- One hour after application of the test article animal No. 1884 showed a diffuse, crimson red conjunctiva with individual vessels not easily discernible, a swelling above normal and a discharge different from normal. In animal No. 1885 a diffuse, crimson red conjunctiva with individual vessels not easily discernible were observed as well as a swelling above normal. Animal No. 1886 showed some conjunctival vessels definitely injected, a swelling above normal and a discharge different from normal. In animal No. 1887 some conjunctival vessels definitely injected and a swelling above normal were observed.
24 hours after application of the test article animals No. 1884, No. 1885, No. 1886 and No. 1887 showed some conjunctival vessels definitely injected and a swelling above normal.
48 and 72 hours after application of the test article all four animals were free of any signs of eye irritation.
ASSESSMENT
According to the CLP Regulation (EC) No 1272/2008 the substance is considered to have irreversible effects on the eye (category 1) if, when applied to the eye of an animal, a substance produces:
1. at least in one animal effects on the cornea, iris or conjunctiva that are not expected to reverse or have not fully reversed within an observation period of normally 21 days; and/ or
2. at least in 2 of 3 tested animals, a positive response of: corneal opacity >= 3 and/or iritis > 1.5
calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material.
The substance is considered to be irritant to the eyes (category 2) if, when applied to the eye of an animal, a substance produces:
1. at least in 2 of 3 animals, a positive response of: corneal opacity >= 1 and/or iritis >= 1 and/or conjunctival redness >= 2 and/or conjunctival oedema (chemosis) >= 2
2. calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item is not eye irritating.
- Executive summary:
In the current study the potential eye irritant effect of the test item was assessed according to the OECD 405 and EEC Guideline B.5 and in compliance to GLP. The day before testing both eyes of the animals were examined to ensure there were no defects or irritation.
In this test only one eye was treated while the other eye remains untreated and serves as control.
0.1 ml of the test article was placed in one eye of the rabbits by gently pulling the lower lid away from the eyeball to form a cup into which the test article was dropped. The lids were then gently held together for 1 second.
The eyes were examined and the grade of ocular reaction was recorded one hour and 24 hours later. After the first 24 hour reading Fluorescein was instilled. After rinsing the eyes were examined again using UV-light to detect possible corneal damage. The eyes were also examined 48 and 72 hours after the treatment.
The study was initiated with one rabbit. Since no marked eye irritation was seen in this animal another three rabbits were included in the study.
Therefore, in total 4 female albino rabbits were exposed to the test article. The eyes were examined and the changes were graded according to a numerical scale one hour, 24, 48 and 72 hours after dosing.
No or only slight signs of irritation were observed on the treated eyes.
The following mean values, based on the results from the 24, 48 and 72 hour readings, were calculated: Cornea opacity 0.0; Iris lesion 0.0; Redness of conjunctiva 0.3 and Oedema of conjunctiva 0.3. All findings were reversible within 48h.
Based on these results, the test item shall not be classified as eye irritating.
According to the CLP regulation the test item shall not be classified as eye irritating
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