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EC number: 279-815-0 | CAS number: 81782-77-6
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- Not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: A non GLP study performed to sound scientific principles with a sufficient level of detail to assess the quality of the submitted data.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- A preliminary skin irritation study was performed prior to initiation of the sensitisation study. The irritation study was conducted to define the concentration to be used for the definitive test; the maximum non-irritating concentration and the minimum irritant concentration. Each animal received a topical induction with the test material at concentrations of 100, 30, 10 or 3% for 21 consecutive days. Animals then received two topical challenge exposures at or below the minimum irritating concentration. Sensitisation was then measured 24, 48 and/or 72 hours after challenge application.
- GLP compliance:
- no
- Remarks:
- Study predates GLP.
- Type of study:
- open epicutaneous test
Test material
- Reference substance name:
- 4-methyl-3-decen-5-ol
- EC Number:
- 279-815-0
- EC Name:
- 4-methyl-3-decen-5-ol
- Cas Number:
- 81782-77-6
- Molecular formula:
- C11H22O
- IUPAC Name:
- 4-methyldec-3-en-5-ol
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: Ethanol
- Concentration / amount:
- 100, 30, 10 and 3%
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: Ethanol
- Concentration / amount:
- 100, 30, 10 and 3%
- No. of animals per dose:
- One to six groups of animals were used per concentration, where each group consisted of 6 to 8 animals.
- Details on study design:
- RANGE FINDING TESTS: A single 0.025 mL application of each test concentration was applied to a 2 cm² patch of skin, previously clipped free of hair. The test material was applied at the following concentrations; 100, 30, 10 and 3%. The skin reaction was recorded 24 hours after application. The minimum irritant and maximum non-irritant concentrations were taken forward to the definitive test. The minimum irritant concentration was defined as the lowest concentration that caused skin irritation; the maximum non-irritant concentration was defined as the highest concentration that did not elicit a macroscopic skin reaction. The lowest irritation concentration after a single application was determined to be 30% and the highest non-irritating concentration was 10%.MAIN STUDYA. INDUCTION EXPOSURE- Site: 8 cm² on the clipped flank of each animal.- Frequency of applications: Daily.- Duration: Three weeks.- Observations: The skin irritation was observed 4 hours after application or at the end of each week. The maximum non-irritant and minimal irritation concentrations were also recorded.- Concentrations: 100, 30, 10 and 3%.- Application: A 0.1 mL aliquot of each test solution was applied using a pipette.- Observation: Skin irritation was measured 24 hours after application or at the end of the week. The application site was changed for animals which displayed a very strong reaction.B. CHALLENGE EXPOSURE- No. of exposures: Two exposures.- Days of challenge: 21 and 35.- Site: The 2 cm² area on the contralateral flank of each animal.- Concentrations: The test material was applied at concentrations at the minimal irritating concentration and some lower concentrations.- Application: A 0.025 mL aliquot was applied using a pipette.- Evaluation (hr after challenge): Reactions were scored 24, 48 and/or 72 hours after application.
- Challenge controls:
- Six to eight untreated animals (or animals pre-treated with the vehicle) were submitted for the challenge exposure as described above.
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 10
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 10
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Remarks on result:
- no indication of skin sensitisation
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 10
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 10
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Remarks on result:
- other:
Any other information on results incl. tables
Results
The highest non-irritating concentration after a single application of the test material in ethanol was 10%. Only very slight skin irritation occurred with repeated applications.
Table 1. Skin Irritation
Concentration % |
Skin Irritation After Days |
||
7 |
14 |
21 |
|
100 |
++* |
++* |
+ |
30 |
+ |
++* |
+ |
10 |
(+) |
(+) |
(+) |
3 |
- |
- |
- |
Degree of skin irritation; - none, + slight, ++ moderate, +++ strong.
* Application site was changed.
Table 2. Skin Sensitization
Induction Concentration % |
Sensitization Rate (Number of Positive Animals/ Total tested) |
|
Day 21 |
Day 35 |
|
100 |
0/6 |
0/6 |
30 |
0/6 |
0/6 |
10 |
0/6 |
0/6 |
3 |
0/6 |
0/6 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the test, none of the tested animals elicited a positive reaction to the challenge exposure. Accordingly the test material was considered to be non-sensitizing.
- Executive summary:
The skin sensitisation potential of the test material was determined in an open epicutaneous test. This study predates GLP and was performed to sound scientific principles.
A preliminary test was conducted to define the test concentrations for the definitive test; the maximum non-irritating and minimum irritant concentrations. In the definitive test, guinea pigs received daily topical induction applications of the test material in solution with ethanol at 100, 30, 10 and 3% for 21 consecutive days. A 0.1 mL aliquot of the appropriate test solution was applied to an area 8 cm² located on the flank of each animal and left uncovered. Each animal was challenged on the untreated flank on days 21 and 35 with a 10% of less test solution. The sensitisation potential was scored 24, 48 or 72 hours after challenge.
Under the conditions of the test, the highest non-irritating concentration after a single application of the test material in ethanol was 10%. Only very slight skin irritation occurred with repeated applications. None of the tested animals elicited a positive reaction to the challenge exposure. Accordingly the test material was considered to be non-sensitizing.
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