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EC number: 208-868-4 | CAS number: 544-35-4
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- May - July 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP and guideline compliant study with minor deviations. Methyl linoleate (CAS# 112-63-0) was used as a structural analogue read-across substance for skin sensitization hazard identification of ethyl linoleate. It can be expected that methyl linoleate would exert similar characteristics in pathophysiological mechanism of skin sensitization. Upon activity of dermal esterases, methyl linoleate would be cleaved into linoleic acid and methanol, representing sufficient similarity to the metabolites linoleic acid and ethanol, resulting from cleavage of ethyl linoleate.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- only 10 test animals are used
- GLP compliance:
- yes
- Type of study:
- Buehler test
Test material
- Reference substance name:
- Methyl linoleate
- EC Number:
- 203-993-0
- EC Name:
- Methyl linoleate
- Cas Number:
- 112-63-0
- IUPAC Name:
- methyl octadeca-9,12-dienoate
- Reference substance name:
- Octadecadienoic acid methyl ester
- IUPAC Name:
- Octadecadienoic acid methyl ester
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): octadecadienoic acid methyl ester
- Physical state: liquid
- Lot/batch No.: 89F0928
- Storage condition of test material: cool and dark
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Crl:(HA)BR
- Source: Charles River, D-Sulzfeld
- Age at study initiation:approx. 6 weeks
- Weight at study initiation: approx. 340 g (main study)
- Housing: air-conditioned, groups of 2-3 animals in Makrolon Type IV cages with standard softwood bedding
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 -25°C
- Humidity (%): 45 - 70%
- Air changes (per hr): 8
- Photoperiod (hrs dark / hrs light): 12h dark / 12h
IN-LIFE DATES: From: To:
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- olive oil
- Concentration / amount:
- Preliminary study: 10, 20, 30, 40, 50, 70, 90%
Main Study:
Induction: minimal irritating concentration (solution of 40%)
Challenge: maximally non-irritating concentration (solution of 20%)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- olive oil
- Concentration / amount:
- Preliminary study: 10, 20, 30, 40, 50, 70, 90%
Main Study:
Induction: minimal irritating concentration (solution of 40%)
Challenge: maximally non-irritating concentration (solution of 20%)
- No. of animals per dose:
- 10
- Details on study design:
- RANGE FINDING TESTS:
- left flank: 30 - 50 - 70 - 90%
- right flank: 10 - 20 - 30 - 40%
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6h
- Test groups: 10 animals
- Control group: 2 x 10 animals
- Site: left cranial sheared flank
- Frequency of applications: once a week
- Concentrations: 40%
B. CHALLENGE EXPOSURE
- Exposure period: 6 h
- Site: bilaterally to sheared flanks of test animals and control group 1 animals
- Concentrations: 20%
- Evaluation (hr after challenge): 24, 48 h - Challenge controls:
- The control group 2 was treated with olive oil in the first and second week after the challenge of the other groups in order to estimate the influence of the vehicle.
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- No results available.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 20%. No with. + reactions: 5.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 20%. No with. + reactions: 2.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Olive oil
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: Olive oil. No with. + reactions: 3.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- olive oil
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: olive oil. No with. + reactions: 1.0. Total no. in groups: 10.0.
Any other information on results incl. tables
24 hours | 48 hours | |||
control animals (10)left / right | Test animals (10)left / right | Control animals (10)left / right | Test animals (10)left / right | |
none | 4 / 7 | 5 / 5 | 6 / 9 | 7 / 7 |
weak | 5 / 3 | 5 / 5 | 2 / 1 | 3 / 2 |
moderate | 1 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
strong | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Since no increased dermal alterations (incidence and severity) were observed in the animals of the treatment group compared with the animals of the control group after the challenge, the test substance is proved to be a "non-sensitizer" on the skin of guinea pigs.
- Executive summary:
The purpose of the study was to assess the sensitizing potential of the test substance on the skin of guinea pigs by epicutaneous application under an occlusive patch following an induction period.
The test substance was tested on the skin using a "non-adjuvans-methos" (Buehler test). In total 30 guinea pigs of the strain "Crl:(HA)BR" were used as the test sytem.
According to the results of the preliminary studies, a 40 % dilution of the test substance was the minimally irritating, a 20 % dilution of the test substance was the maximally non-irritating concentration.
After triple (once a week) epicutaneous application (occlusive/6h) of the minimally irritating concentration to induce sensitization, a challenge of the animals was performed with the maximally non-irritating concentration (occlusive/6h).
The treatment animals and the control animals as well were without any distinct dermal effects after challenge. The challenge reactions after exposure to olive oil in the experimental animals of the control group 2 were weak to moderate dermal reactions. Since no increased dermal alterations (incidence and severity) were observed in the animals of the treatment group compared with the animals of the control group after the challenge, the test substance is proved to be a "non-sensitizer" on the skin of guinea pigs.
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