Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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EC number: - | CAS number: -
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- other: case report
- Adequacy of study:
- weight of evidence
- Study period:
- May 1, 1995 - September 12, 1995
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: It concerns a single case report.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 996
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- case report
Test guideline
- Qualifier:
- no guideline followed
- GLP compliance:
- no
Test material
- Test material form:
- other: aqueous solution
- Details on test material:
- - Physical state: Aqueous solution
- Appearance: No data
- Composition of test material, percentage of components: see section confidential details on test material
Constituent 1
Results and discussion
Any other information on results incl. tables
- Patch testing gave a ++ reaction to her contact lens cleansing fluid (undiluted)
- Later, the separate ingredients of this product, obtained from the manufacturer, were tested, which resulted in a ++ reaction to the product and a ++ reaction to the ingredient disodium cocoamphodipropionate 1% aqueous. Only negative reactions were observed with the other ingredients tested.
- 21 controls were negative to a concentration of 1% disodium cocoamphodipropionate.
- Subsequent testing with a dilution series showed positive reactions to disodium cocoamphodipropionate 1%, 0.6%, 0.3% and 0.1% aqueous.
- In addition, only negative reactions were seen with pure coconut oil, with propionic acid (at 3%) and with methanol (at 100% and 30%).
Applicant's summary and conclusion
- Conclusions:
- Sensitisation to skin is possible, as shown in this case study. Despite a long history of use, cases of sensitization to the substance are very rare. This is the only known case report.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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