Registration Dossier

Administrative data

Description of key information

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.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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
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
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
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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)

Justification for classification or non-classification

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.