Registration Dossier
Registration Dossier
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EC number: 247-979-2 | CAS number: 26761-45-5
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This is a case study report of sensitization in one individual. There is limited study detail.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 979
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- case report
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Standar human patch test methodology.
- GLP compliance:
- no
Test material
- Reference substance name:
- 2,3-epoxypropyl neodecanoate
- EC Number:
- 247-979-2
- EC Name:
- 2,3-epoxypropyl neodecanoate
- Cas Number:
- 26761-45-5
- Molecular formula:
- C13H24O3
- IUPAC Name:
- (oxiran-2-yl)methyl 2,2-dimethyloctanoate
- Details on test material:
- As per the publication.
Constituent 1
Method
- Type of population:
- occupational
- Ethical approval:
- not specified
- Subjects:
- One male, 16 years old.
- Clinical history:
- Patent presented with severe dermatitis on the hands, arms, face, neck and genital area. The patient had been working for nine daya filling undiluted epoxy resins hardeners and reactive diluents in drums.
- Controls:
- No data from patch testing study.
- Route of administration:
- dermal
- Details on study design:
- Standard human patch testing methodology.
Results and discussion
- Results of examinations:
- Following patch testing exposure, positive dermal responses were observed for a bisphenol A epxy resin at 0.001% in acetone and to 2,3-epoxypropyl neodecanoate (Cardura E) at 0.01% in acetone.
Applicant's summary and conclusion
- Conclusions:
- 2,3-Epoxypropyl neodecanoate elicited a positive dermal response in a male patient previously sensitized to epoxy resins, and/or hardeners and reactive diluents. The positive dermal responses were observed at a concentration of 0.01% 2,3-epoxypropyl neodecanoate (Cardura E) in acetone. This human clinical finding supports the positive result of the guinea pig Maximization test conducted on the test substance.
- Executive summary:
A male individual exposed to epoxy resins, epoxy resin hardeners and reactive diluents including 2,3 -epoxypropyl neodecanoate (Cardura E) was patch tested to determine skin sensitivity. The patient elicited positive dermal responses to epoxy resin at 0.001% and to 2,3 -epoxypropyl neodecanoate at a concentration of 0.01%. The data demonstrate that 2,3 -epoxypropyl neodecanoate can elicite a positive dermal reaction in humans previously sensitized to epoxy resins and/or components used in the manufacture of epoxy resins.
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