Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Administrative data

Endpoint:
basic toxicokinetics, other
Remarks:
expert statement
Type of information:
other: expert statement

Data source

Reference
Reference Type:
other: expert statement
Title:
Unnamed
Year:
2018

Materials and methods

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of 4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane and Orthophosphoric acid, oligomeric reaction products with 4,4'-isopropylidenediphenol -1-chloro-2,3-epoxypropane co-oligomer
EC Number:
941-183-5
Molecular formula:
C21 H24 O4 (monomer of BADGE), C63 H72 O20 P2 (example of trimer of BADGE-phosphate ester), C84 H96 O28 P3 (example of tetramer of BADGE-phosphate ester), further oligomers up to MW approx. 3500 Da
IUPAC Name:
Reaction mass of 4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane and Orthophosphoric acid, oligomeric reaction products with 4,4'-isopropylidenediphenol -1-chloro-2,3-epoxypropane co-oligomer
Test material form:
liquid

Results and discussion

Applicant's summary and conclusion

Executive summary:

No specific study was performed on the absorption, distribution, metabolism, excretion (ADME) of this substance (EP-49-10P2), but data are currently available fromin vivotoxicology studies.

 

The substance, EP-49-10P2, is a UVCB substance composed of 10%-20% phosphoric acid esters of BADGE (bisphenol A diglycidyl ethers, CAS 1675-54-3) which are dissolved in BADGE (80%-90%). The substance is a very viscous liquid and has low water solubility. An experimental value of 82 mg/l was determined after six days. However, the epoxide groups of BADGE are known to hydrolyse to the respective diol-groups increasing water solubility over time.

Themolecular weight (MW) of BADGE monomer amounts to 340 Da; dimers and trimers have higher MW. The molecular weights of the esters range from approx. 1200 Da to 3500 Da. Determination of the surface activity of EP-49-10P2 indicated that the substance has surface activity. Accordingly, there is no true value for lipophilicity.

The vapour pressure of BADGE is very low (approx. 5 x 10^-8 Pa).

Based on the fact that the substance EP-49-10P2 contains 80%-90% BADGE it is concluded that the toxic properties of the substance EP-49-10P2 are the same as those of BADGE. Accordingly, read-across was made in the present REACH registration dossier from study results obtained with BADGE.

After oral exposure to EP-49-10P2 absorption ofBADGEand systemic distribution is to be expected based on the low molecular weight. In repeat dose feeding studies performed with BADGE effects in several organs were observed at high doses indicating systemic distribution.

Systemic availability of EP-49-10P2 after dermal application is expected to be low based on the very viscous form of the substance. However, due to skin irritating and sensitising properties of BADGE skin permeability might be increased after dermal contact.

Availability of EP-49-10P2 under a vapour state can be excluded because of its very low vapour pressure; formation of inhalable aerosols from the very viscous liquid is unlikely.

There is no information on metabolism and excretion of EP-49-10P2.

 

Based on the available information the bioaccumulation potential of EP-49-10P2 cannot be assessed.