Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- other: expert assessment
- Adequacy of study:
- key study
- Study period:
- 2019
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: assessment based on experimental data on analogous substance supported by information on toxicokinetics profile
Data source
Reference
- Reference Type:
- other: expert assessment
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- Assessment based on experimental data on analogous substance supported by information on toxicokinetics profile
- GLP compliance:
- no
- Type of study:
- other: assessment based on experimental data on analogous substance supported by information on toxicokinetics profile
Test material
- Reference substance name:
- 4,4’-isopropylidenediphenol, reaction products with 1-chloro-2,3-epoxypropane, mono, di and triesters with acrylic acid
- Molecular formula:
- not applicable - the substance is an UVCB
- IUPAC Name:
- 4,4’-isopropylidenediphenol, reaction products with 1-chloro-2,3-epoxypropane, mono, di and triesters with acrylic acid
- Test material form:
- liquid
Constituent 1
Results and discussion
In vitro / in chemico
Results
- Key result
- Parameter:
- other: assessment based on experimental data on analogous substance supported by information on toxicokinetics profile
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- 4,4’-isopropylidenediphenol, reaction products with 1-chloro-2,3-epoxypropane, mono, di and triesters with acrylic acid (EC 948-054-2) should be classified as Skin Sens. 1; H317.
- Executive summary:
An assessment was conducted based on experimental data on analogous substance supported by information on toxicokinetics profile of 4,4’-isopropylidenediphenol, reaction products with 1-chloro-2,3-epoxypropane, mono, di and triesters with acrylic acid (EC 948-054-2). It was concluded it should be classified as Skin Sens. 1; H317. It is not considered necessary to carry out further testing.
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