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EC number: 222-581-1 | CAS number: 3539-43-3
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 20, 2019 to March 21, 2Ol9
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- The MatTek Corporation In Vitro EpiOcula Eye Initation Test (OCL-200-EIT) (OECD 492)
Protocol: Epi0cularrM Eye Iritation Test (OCL 200-EIT) Protocol Date: 6/29/15 - Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Hexadecyl dihydrogen phosphate
- EC Number:
- 222-581-1
- EC Name:
- Hexadecyl dihydrogen phosphate
- Cas Number:
- 3539-43-3
- Molecular formula:
- C16H35O4P
- IUPAC Name:
- hexadecyl dihydrogen phosphate
- Test material form:
- solid: particulate/powder
- Details on test material:
- Product commercial name is ColaFax CPE
Constituent 1
- Specific details on test material used for the study:
- 1-Hexadecanol, 1-(dihydrogen phosphate), (ColaFax CPE),
100% Active; Iot Number:64252F18 (100%)
Test animals / tissue source
- Species:
- human
- Strain:
- other: stratified human keratinocytes
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 50 micrograms
- Duration of treatment / exposure:
- The tissues were incubated at standard culture conditions for 6 hours +/- 15 minutes.
- Duration of post- treatment incubation (in vitro):
- At the end of the Post-Soak immersion, each insert was removed from the Assay Medium, the medium was decanted offthe tissue, and the insert was blotted on absorbent material, and transfsned to the appropriate weli of the preJabeled Gwell plate containing I ml of warm Assay Medium. The tissues were incubated for 18 +/- 0.25 hours at standard culture conditions (Post-treatment Incubation).
- Number of animals or in vitro replicates:
- Duplicates
- Details on study design:
- *The EpiocularrM human cell construct (MatTek Corporation) is used in the assay. The use of EpiOcular cultures offers features appropriate for a model of ocular irritation. First, the model is composed of stratified human keratinocytes in a three-dimensional structure. Next, test materials can be applied topically to the model so that water insoluble materials may be tested . . . The toxicity of the test article (and thus the ocular initation potential) is evaluated by the relative
viability of the treated tissues relative to the negative control-treated tissues. Viability is determined by the NAD(P)H-dependent microsomal Enzyme reduction of MTT (and to a lesser extent, by the succinate dehydrogenase reduction of MTT) in control and test article-treated cultures."l
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- other: % viability
- Run / experiment:
- 1
- Value:
- 2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- other: % viability
- Run / experiment:
- 2
- Value:
- 2.2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- As per MatTek the assay meets the negative control criteria if the mean OD-570 for the negative control tissues is > 0.8 and < 2.5. The value is 1.764 and it meets the acceptance criteria.
As per MatTek and OECD 492,the assay meets the positive control criteria if the mean viability of the positive control tissues expressed as the percent of the negative control tissues is < 50%. The value is 47.3 and it meets the acceptance criteria
As per MatTek and OECD 492, the assay meets the acceptance criteria if the difference of viability between the two relating tissues of a single chemical is < 20% in the same run. The diflerences for all articles are below 20% and all meet the acceptance criteria.
Any other information on results incl. tables
The test chemical is identified as not requiring classification and labelling according to UN GHS (No Category) if the mean percent tissue viability after exposure and post-exposure incubation is more than (>) 60%. In this case no further testing in other test methods is required.
The test chemical is identified as potentially requiring classification and labelling according to UN GHS (Category 2 or Category 1) if the mean percent tissue viability after exposure and post exposure incubation is less than or equal (<=) to 60%. When the final mean percent tissue viability is less than or equal (<=) to 60% further testing with other test methods will be required because the Epiocular EIT shows a certain number of false positive results and cannot resolve between UN GHS Categories I and 2.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Under the conditions of this test, with a mean tissue viability of 2.1%, the test article, 1-Hexadecanol, 1-(dihydrogen phosphate), (ColaFax CPE), 100% Active;
is considered an irritant. However, the actual classification i.e. Eye irritant Cat 2 or eye damage Cat 1 cannot be distinguished precisely.
It is highly likely though that the very low result compared with the positive control (methyl acetate = eye irritant Cat 2) i.e. 2.1% verses 47.3%, that from a precautionary approach, this substance should be classified as Eye Damage Cat 1
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