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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
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Remarks:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1975
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: The test has been performed on healthy adult volunteers without OECD or GLP guideline and it has been well conducted, however, the amount of substance tested is missing and the study report is limited.
- Reason / purpose for cross-reference:
- reference to same study
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Remarks:
- 25 male/females
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The patch site was pre-treated for 24 hours with 2.5% to 5% aqueous sodium lauryl sulfate under occlusion.
Induction: test substance at 2% in petrolatum under occlusion on 5 alternate-day 48 hour periods on the same site on the volar forearm or back of all subjects with a 24 hour rest period between removal and reapplication of the patch.
Challenge: occluded challenge patches were applied for 48 hours after a rest period of 10 - 14 days.
The reactions were read at the patch removal (after 48 h) and 24 hours after the patch removal (after 72 h) and the sensitisation index was noted. - GLP compliance:
- no
- Type of population:
- not specified
- Ethical approval:
- not specified
- Subjects:
- 25 male/female volunteers
Age varies from 18 to 39 years old - Route of administration:
- dermal
- Details on study design:
- PRE-TREATMENT: 2.5 - 5 % sodium lauryl sulfate for 24h
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 5 alternate-day
- Site: volar forearms or back, under occlusion
- Duration exposure: 48h
- Duration between removal and re-application of the patch: 24h
- Concentrations: 2% in petrolatum
B. CHALLENGE EXPOSURE
- Rest period before the challenge: 10 - 14 days
- No. of exposures: 1
- Exposure period: 48h
- Site: same as induction, under occlusion
- Concentrations: 2% in petrolatum
- Evaluation: on removal of patch (48 h after challenge) and 24 h later (72 h after challenge) - Results of examinations:
- No reactions were observed
- Conclusions:
- No reactions were observed
- Executive summary:
A human maximisation study was conducted on 25 subjects with ethyl octanoate at 2% in petrolatum. Occluded applications were made for five alternate-day 48-hour periods to the forearms or backs, and the sites were pretreated for 24 hours with 2.5 - 5% aqueous sodium lauryl sulfate (SLS) under occlusion. The occluded challenge patches were applied for 48 hours after a rest period of 10 - 14 days. The reactions were read at the patch removal and 24 hours after the patch removal, however, no reactions were observed.
Maximisation results
challenge | |||||
Subject number | Age | Race | Sex | 48-hours | 72-hours |
1 | 21 | W | F | 0 | 0 |
2 | 18 | W | F | 0 | 0 |
3 | 18 | W | F | 0 | 0 |
4 | 18 | W | M | 0 | 0 |
5 | 18 | B | F | 0 | 0 |
6 | 18 | W | F | 0 | 0 |
7 | 18 | W | M | 0 | 0 |
8 | 18 | W | F | 0 | 0 |
9 | 27 | B | F | 0 | 0 |
10 | 20 | B | F | 0 | 0 |
11 | 18 | W | F | 0 | 0 |
12 | 18 | B | M | 0 | 0 |
13 | 23 | W | M | 0 | 0 |
14 | 18 | W | F | 0 | 0 |
15 | 27 | B | F | 0 | 0 |
16 | 18 | W | F | 0 | 0 |
17 | 18 | W | F | 0 | 0 |
18 | 39 | B | M | 0 | 0 |
19 | 29 | W | F | 0 | 0 |
20 | 21 | W | F | 0 | 0 |
21 | 18 | B | M | 0 | 0 |
22 | 30 | W | F | 0 | 0 |
23 | 29 | W | M | 0 | 0 |
24 | 26 | B | M | 0 | 0 |
25 | 39 | W | M | 0 | 0 |
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
- Endpoint addressed:
- skin irritation / corrosion
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- In a pre-test for a human maximisation study, a 48 hour closed patch test on the forearms or backs of 25 healthy, male and female volunteers. Vehicle was petrolatum
- GLP compliance:
- no
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
Method
- Ethical approval:
- not specified
- Details on study design:
- In a pre-test for a human maximisation study, a 48 hour closed patch test on the forearms or backs of 25 healthy, male and female volunteers, with ages ranging from 18 to 39 years old was performed. Vehicle was petrolatum.
- Exposure assessment:
- measured
- Details on exposure:
- INDUCTION EXPOSURE
- epicutaneous, occlusive
- No. of exposures: 1
- Site: volar forearms or back
- Duration exposure: 48h
- Concentrations: 2% in petrolatum
Results and discussion
- Results:
- The substance did not produced irritation in 25 volunteers.
Applicant's summary and conclusion
- Conclusions:
- The substance did not produced irritation in 25 volunteers and should not be considered as an irritant.
- Executive summary:
Irritation was evaluated prior to a human maximisation study, and a 48-hour occluded patch test was conducted on the forearms or backs of 25 subjects with ethyl octanoate at 2% in petrolatum. No reactions were observed.
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