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Diss Factsheets
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EC number: - | CAS number: -
- 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 (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- adopted 24 April 2002
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- methyl tetradecanoate, chloro
- Molecular formula:
- C13H26Cl4COOCH3 and C13H25Cl5COOCH3 (primary isomers based on product weight of 35-40% Cl by weight)
- IUPAC Name:
- methyl tetradecanoate, chloro
- Reference substance name:
- Methyl octadecanoate, chloro
- Molecular formula:
- C17H30Cl4COOCH3, C17H29Cl5COOCH3 , and C17H28Cl6COOCH3 (primary isomers based on 35-40% Cl by weight)
- IUPAC Name:
- Methyl octadecanoate, chloro
- Reference substance name:
- Methyl hexadecanoate, chloro
- Molecular formula:
- C15H28Cl4COOCH3 and C15H27Cl5COOCH3 (primary isomers based on 35-40% Cl by weight)
- IUPAC Name:
- Methyl hexadecanoate, chloro
- Test material form:
- liquid
- Details on test material:
- This is a UVCB substance developed from the chlorination of fatty acid methyl esters.
Constituent 1
Constituent 2
Constituent 3
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Remarks:
- CBA/CaOlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- Only nulliparous and non-pregnant female mice were used. Age 7-8 weeks at the beginning of acclimatisation.
Single caging. The animals were distributed into the test groups at random and identified by cage number.
Environment:
temperature 22 ± 3°C
relative humidity 30-70%
artificial light 6.00 a.m. - 6.00 p.m.
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0, 25, 50, 100%
- No. of animals per dose:
- 4 females
- Details on study design:
- Each test group of mice was treated by topical (epidermal) application to the dorsal surface of each ear lobe (left and right) with different test item concentrations of 25, 50, and 100% (w/v) in acetone:olive oil (4+1 ). The application volume, 25 μI, was spread over the entire dorsal surface (0 ~ 8 mm) of each ear lobe once daily for three consecutive days. A further group of mice was treated with an equivalent volume of the relevant vehicle alone (control animals).
Five days after the first topical application, all mice were administered with 250 μI of 81.7 μCi/ml 3HTdR (corresponds to 20.4 μCi 3HTdR per mouse) by intravenous injection via a tail vein. The draining lymph nodes were rapidly excised and pooled per group (8 nodes per group). Single cell suspensions (in phosphate buffered saline) of pooled lymph node cells were prepared by gentle mechanical disaggregation through stainless steel gauze (200 μm mesh size). After washing two times with phosphate buffered saline (approx. 10 ml) the lymph node cells were resuspended in 5 % trichloroacetic acid (approx. 3 ml) and
incubated at approximately +4 °C for at least 18 hours for precipitation of macromolecules. The precipitates were then resuspended in 5 % trichloroacetic acid (1 ml) and transferred to plastic scintillation vials with 10 ml of 'Ultima Gold' scintillation liquid and thoroughly mixed.
The level of 3HTdR incorporation was then measured on a beta-scintillation counter. Similarly, background 3HTdR levels were also measured in two 1 ml-aliquots of 5 % trichloroacetic acid. The beta-scintillation counter expresses 3HTdR incorporation as the number of radioactive disintegrations per minute (DPM).
The proliferative response of lymph node cells is expressed as the number of radioactive disintegrations per minute per lymph node (DPM/node) and as the ratio of 3HTdR incorporated into lymph node cells of test lymph nodes relative to that recorded for control lymph nodes (stimulation index). Before DPM/node values were determined, mean scintillation-background DPM was subtracted from test and control raw data. - Positive control substance(s):
- not specified
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1.26
- Test group / Remarks:
- 25% Concentration
- Key result
- Parameter:
- SI
- Value:
- 2.31
- Test group / Remarks:
- 50% Concentration
- Key result
- Parameter:
- SI
- Value:
- 1.82
- Test group / Remarks:
- 100% Concentration
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study Stimulation Indices (S.1.) of 1.26, 2.31, and 1.82 were determined with the test item at concentrations of 25, 50, and 100% in acetone: olive oil (4+1 ), respectively. The EC3 value could not be calculated, since all SI's are below 3.
The test item is not a skin sensitizer. - Executive summary:
In the study the C16 and C18 chlorinated methyl esters were dissolved in acetone: olive oil (4+1) was assessed for
possible contact allergenic potential. For this purpose a local lymph node assay was performed using test item concentrations of 25, 50, and 100%.
The animals did not show any clinical signs during the course of the study and cases of mortality were not observed.
In this study Stimulation Indices (S.1.) of 1.26, 2.31, and 1.82 were determined with the test item at concentrations of 25, 50, and 100% in acetone: olive oil (4+1 ), respectively. The EC3 value could not be calculated, since all SI's are below 3.
The test item is not a skin sensitizer.
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