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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
sub-chronic toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
[Please provide information for all of the points below. Indicate if further information is included as attachment to the same record, or elsewhere in the dataset (insert links in 'Cross-reference' table)]

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
[Describe why the read-across can be performed (e.g. common functional group(s), common precursor(s)/breakdown product(s) or common mechanism(s) of action]

The read-across target substance EP-49-10P2 is composed of a mixture of phosphate esters with bisphenol A diglycidylether (BADGE, CAS 1675-54-3, EC 216-823-5) that is dissolved in BADGE. The amount of esters in the target substance EP-49-10P2 ranges between 10% and 20%; the large rest is BADGE. Therefore, BADGE can be used as read-across source substance.

Based on the high content of BADGE (80-90%) and on the fact that the phosphate esters have higher molecular weights (MW > 1200 Da – approx. 3500 Da) and accordingly lower bioavailability it is concluded that the toxic and eco-toxic potential of EP-49-10P2 will be the same as that of BADGE. With the phosphate esters no hazardous functional groups are introduced.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
[Provide here, if relevant, additional information to that included in the Test material section of the source and target records]

3. ANALOGUE APPROACH JUSTIFICATION
[Summarise here based on available experimental data how these results verify that the read-across is justified]

No experimental data from toxicological or eco-toxicological studies with the target substance EP-49-10P2 are available for comparison of effects. However, based on the composition of EP-49-10P2 it is considered justified to make read-across from study results obtained with the read-across source substance BADGE in order to fulfil the information requirements for REACH registration of EP-49-10P2.
Reason / purpose for cross-reference:
read-across source
Key result
Dose descriptor:
NOAEL
Effect level:
50 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: see remarks
Key result
Critical effects observed:
not specified
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
50 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Changes in organs due to treatment were either consistent with irritation due to a portal of entry effect or were judged conclusive but insufficient for classification.