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EC number: 271-516-3 | CAS number: 68583-51-7
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Study period:
- 07 Mar - 07 Apr 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Basic data given (comparable to guideline study). Lack of individual test results and test material details. No data on reliablility check (positive control)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- lack of individual test results and test material details. No data on reliability check (positive control)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A non-LLNA test is available that was performed prior to the current data requirements, stipulated in Regulation (EC) No 1907/2006. In accordance with the same Regulation, the data was included to avoid unnecessary testing.
Test material
- Reference substance name:
- Myristic acid, monoester with propane-1,2-diol
- EC Number:
- 249-395-3
- EC Name:
- Myristic acid, monoester with propane-1,2-diol
- Cas Number:
- 29059-24-3
- Molecular formula:
- C17H34O3
- IUPAC Name:
- 2-hydroxypropyl myristate
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright white
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Fa. Winkelmann, Borchen, Germany
- Weight at study initiation: 352.6 g (control group, range finding study) and 349.4 g (treatment group, range finding study); 298.5 g (control group, main study) and 298.4 g (treatment group, main study)
- Housing: animals were housed in groups of 2-3 in Makrolon IV cages
- Diet: Altromin-Haltungsdiät 3032 DK (Fa. Altromin GmbH, Lage, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 50-60
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Paraffin perliquid DAB 8
- Concentration / amount:
- Intradermal induction: 0.1%
Epicutaneous induction: 15% - Day(s)/duration:
- intradermal induction: single treatment; epicutaneous induction: 48 h
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Paraffin perliquid DAB 8
- Concentration / amount:
- 2.5% on one flank, 5% on the other flank
- Day(s)/duration:
- 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 2 x 3 (range finding study)
20 (main study) - Details on study design:
- RANGE FINDING TESTS:
Test group A:
To evaluate the concentration for intracutaneous induction 3 guinea pigs were tested with 0.1, 0.5, 1.0 and 2.0% (intracutaneous) of the test substance. The 0.1% concentration of the intracutaneous application caused a sufficient irritation on the skin. Therefore, a 0.1% concentration was chosen for intracutaneous induction exposure.
Test group B:
To evaluate the epicutaneous induction and the challenge concentration, 3 guinea pigs were tested with 5, 10 and 15% (epicutaneous) with the test substance. Due to the only slight skin reactions at 15%, this concentration was chosen for epicutaneous induction and 2.5 and 5% as challenge concentration.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/water
Injection 2: the test substance in Paraffin perliquid DAB 8
Injection 3: the test substance in a 1:1 mixture (v/v) FCA/water
Epicutaneous: test substance in Paraffin perliquid DAB 8
- Control group:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/water
Injection 2: Paraffin perliquid DAB 8
Injection 3: Paraffin perliquid DAB 8 in a 1:1 mixture (v/v) FCA/water
Epicutaneous: test substance in Paraffin perliquid DAB 8
- Site: shoulder region (intradermal + epicutaneous)
- Frequency of applications: every 7 days
- Duration: Days 0-8
- Concentrations: intradermal 0.1%, epicutaneous 15%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 20
- Exposure period: 24 h
- Test groups: test substance
- Control group: test substance
- Site: parallel application onto the flank
- Concentrations: 2.5 and 5%
- Evaluation (hr after challenge): 24 and 48 h
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.1%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.1%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- slight redness of the skin
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.1%. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: slight redness of the skin.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.1%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Group:
- positive control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
No mortality was observed in any control or treatment animal.
The individual body weights of the control and test animals showed the expected values.
After intracutaneous induction all animals showed the characteristic reactions after application of FCA (Freund´s complete adjuvant). The test substance without FCA caused moderate skin reactions which were of a lower grade than the reactions caused by FCA alone or by the solution of FCA with the test substance.
After patch removal after the second induction (epicutaneous induction) bloody skin alterations were observed. Later on, this skin reactions changed to necrotic and escharic skin reactions.
24 and 48 h after patch removal (challenge induction) no skin reaction was observed in the treatment animals. In 1 control animal (animal No. 16; 48 h reading) a slight reaction was apparent. According to the author, the results were therefore not presented in table form.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
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