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Diss Factsheets
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EC number: 700-213-5 | CAS number: 947753-66-4
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 September 2007 to 18 October 2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
- Principles of method if other than guideline:
- Repeated Insult Patch Test Protocol No. : 1.01 (Consumer Product Testing Co.)
Although not stated, the procedure used was essentially that of Draize (Procedures for the appraisal of the toxicity of chemicals in foods, drugs, and cosmetics. VIII. Dermal toxicity, Food Drug Cosmetic Law J. 10:722-731, 1955). - GLP compliance:
- yes (incl. QA statement)
- Type of study:
- patch test
- Species:
- human
- Strain:
- other: not applicable
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Participants:
Fifty-six (56) male and female subjects ranging in age from 16 to 76 years. Fifty (50) subjects completed the study. The remaining subjects discontinued their participation for various reasons, none of which were related to the application of the test material.
Inclusion Criteria:
The following criteria applied to study participants: male and female, age 16 or older; an absence of any visible skin disease which might confuse the study results; prohibition on the use of topical or systemic steroids and/or antihistamines for at least seven days prior to study initiation; completion of medical history forms and informed consent forms; considered reliable and capable of following directions.
Exclusion Criteria:
The following applied: ill health; someone under a doctor's care and taking medication that might influence the outcome of the study; pregnant or nursing females; a history of adverse reactions to cosmetics or other personal care products. - Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 20%
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 20%
- No. of animals per dose:
- 50 participants completed the study
- Details on study design:
- Test Material Preparation:
The test material was prepared as a 20% dilution in corn oil.
Application Area:
The upper back between the scapulae served as the treatment area. Approximately 0.2 ml of the test material, or an amount sufficient to cover the contact surface, was applied to a 3/4 inch x 3/4 inch absorbent pad portion of an adhesive bandage. This was then applied to the appropriate treatment site to form an occlusive patch.
Induction Phase:
Patches were applied 3 times weekly (e.g., Monday, Wednesday and Friday) for a total of 9 applications. The site was marked to ensure the continuity of patch applications. Following supervised removal and scoring of the first induction patch, participants were instructed to remove all subsequent induction patches at home, twenty-four hours after application. Site evaluations were performed prior to re-application.
Challenge Phase:
Approximately 2 weeks after induction patch applications, a challenge patch was applied to a virgin (untreated) site adjacent to the original induction patch site, following the same procedure for Induction. The challenge patches were removed and the sites scored at the clinic 24 and 72 hours after applications. - Challenge controls:
- None
- Positive control substance(s):
- no
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 50
- Clinical observations:
- No positive reactions for irritation or allergic contact sensitization.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 20%. No with. + reactions: 0.0. Total no. in groups: 50.0. Clinical observations: No positive reactions for irritation or allergic contact sensitization..
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 50
- Clinical observations:
- No positive reactions for irritation or allergic contact sensitization.
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 20%. No with. + reactions: 0.0. Total no. in groups: 50.0. Clinical observations: No positive reactions for irritation or allergic contact sensitization..
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of this study, test material RX14180 Lot# ABP4-071907 did not indicate a potential for dermal irritation or allergic contact sensitization.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The subject chemical was negative when tested in 56 human volunteers in a HRIPT. The surrogate substance, undecenyl methoxycrylene, was not considered a skin sensitizer when tested in the mouse LLNA.
Migrated from Short description of key information:
The surrogate chemical, undecenyl methoxycrylene, was negative when tested in vivo in an OECD Guideline 429 study (Skin Sensitisation: Local Lymph Node Assay). There was also a study done on human data on the actual test material EHMC, involving 56 humans, which also showed that the substance showed no signs of causing skin sensitisation.
Justification for selection of skin sensitisation endpoint:
There are two studies which provide data for skin sensitisation, one study has been conducted according to OECD guidelines on a read across material UMC. We have assigned a klimisch scale reliability of 2 to this GLP and OECD guideline study as the study is being used for read across.
There is a second study which has been conducted on the actual test substance (EHMC), this study used 56 humans, both studies produced negative results and have been classed as a reliability of 2 on the klimisch scale. We have used the study on human data on EHMC as the key study as this study contains data on the actual substance.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
No study data available
Migrated from Short description of key information:
No study data available
Justification for classification or non-classification
From the data from the key study (Undecenyl methoxycrylene: LOCAL LYMPH NODE ASSAY IN THE MOUSE ), a Stimulation Index of 0.72 was achieved. A positive reaction is identified if the Stimulation Index equals >=3. Therefore it can be concluded that EHMC is not a sensitizer.
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