Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 204-680-1 | CAS number: 124-10-7
- 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

Direct observations: clinical cases, poisoning incidents and other
Administrative data
- Endpoint:
- direct observations: clinical cases, poisoning incidents and other
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Study period:
- 1998-06-29 to 1998-07-03
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test procedure in accordance with generally accepted scientific standards and described in sufficient detail.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
- Study type:
- study with volunteers
- Endpoint addressed:
- skin irritation / corrosion
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: COLIPA
- Deviations:
- yes
- Remarks:
- , lack of details on test substance
- Principles of method if other than guideline:
- 70 µL of the test substances are applied on the back of volunteers for 24 h with occlusive patches (Fin Chamber on Scanpor, 12 mm). The skin is subsequently examinated at 6, 24, 48 and 72 h and effects are graded according to the scale of Frosch and Kligman (1979).
- GLP compliance:
- no
- Remarks:
- GCP compliant (incl. certificate)
Test material
- Reference substance name:
- Methyl oleate
- EC Number:
- 203-992-5
- EC Name:
- Methyl oleate
- Cas Number:
- 112-62-9
- Molecular formula:
- C19H36O2
- IUPAC Name:
- methyl (Z)-octadec-9-enoate
- Details on test material:
- - Name of test material (as cited in study report): methyl oleate
- Analytical purity: no data
Constituent 1
Method
- Type of population:
- general
- Subjects:
- - Number of subjects exposed: 20
- Sex: male and female
- Age: without restriction, not documented - Ethical approval:
- confirmed and informed consent free of coercion received
- Route of exposure:
- dermal
- Reason of exposure:
- intentional
- Exposure assessment:
- measured
- Details on exposure:
- 70 µL of the test substances are applied on the back of volunteers for 24 h with occlusive patches (Fin Chamber on Scanpor, 12 mm).
- Examinations:
- The skin is subsequently examinated at 6, 24, 48 and 72 h and effects are graded according to the scale of Frosch and Kligman (1979).
- Medical treatment:
- No
Results and discussion
- Clinical signs:
- One volunteer developed a slight erythema.
Scores for test substance (mean of all volunteers):
Erythem: 0.11
Erythema, Edema, Desquamation and fissure: 0.11 - Results of examinations:
- Aim of these test method is the induction of skin reactions with concentrations of test substances higher than the commercial use (e.g. undiluted) for comparison of the reactions with positive (e.g. SDS) and negative controls (e.g. water). The slight reactions occurring under these test conditions of occlusive dressing for 24h with the undiluted test substance and the valid positive control SDS lead to the result, that the test substance methyl oleate is not irritating to human skin.
Any other information on results incl. tables
Number of reactions for the parameters erythema, edema and desquamation added up from all time points and differentiated according to the strength.
|
|
Erythema |
Edema |
Desquamation |
||||||||||||
Substance |
Without reaction |
1 |
2 |
3 |
4 |
0 |
1 |
2 |
3 |
4 |
0 |
1 |
2 |
3 |
4 |
0 |
Methyl oleate |
19/20 |
2 |
0 |
0 |
0 |
74 |
0 |
0 |
0 |
0 |
76 |
0 |
0 |
0 |
0 |
76 |
SDS 0.5% |
2/20 |
39 |
11 |
0 |
0 |
26 |
1 |
0 |
0 |
0 |
75 |
25 |
3 |
0 |
0 |
48 |
Water |
19/20 |
1 |
0 |
0 |
0 |
75 |
0 |
0 |
0 |
0 |
76 |
0 |
0 |
0 |
0 |
76 |
Cosmet. Alcohol |
18/20 |
2 |
0 |
0 |
0 |
74 |
0 |
0 |
0 |
0 |
76 |
5 |
0 |
0 |
0 |
71 |
Parrafin oil |
20/20 |
0 |
0 |
0 |
0 |
76 |
0 |
0 |
0 |
0 |
76 |
0 |
0 |
0 |
0 |
76 |
Texapon N28 1% |
7/20 |
28 |
0 |
0 |
0 |
48 |
0 |
0 |
0 |
0 |
76 |
22 |
0 |
0 |
0 |
54 |
Phys. NaCl |
19/20 |
2 |
0 |
0 |
0 |
74 |
0 |
0 |
0 |
0 |
76 |
1 |
0 |
0 |
0 |
75 |
Scoring according to Frosch P.J. & Kligman A.M., The soap chamber test; a new method for assessing the irritancy of soaps, J. Am. Acad. Dermatol., 1979, 1, pp. 35-41:
0 = no reactions
0.5 = minimal or doubtful reactions
1 = slight reactions
2 = moderate reactions
3 = strong uniform reactions
4 = very strong reactions
Applicant's summary and conclusion
- Conclusions:
- The study guideline from COLIPA is in accordance with generally accepted scientific standards, which makes the study report sufficient for assessment. According to C&L guide Art. 3.2.6.1. (EC, 1993a) R38 is to be applied to “substances and preparations which cause significant inflammation of the skin, based on practical observation in humans on immediate, prolonged or repeated contact”. The lack of these effects leads to the classification of the test substance methyl oleate as not irritating to human skin.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
