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

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Link to relevant study records

Reference

Endpoint:

two-generation reproductive toxicity

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

Dose descriptor:

NOAEL

Effect level:

50 mg/kg bw/day (nominal)

Sex:

male

Basis for effect level:

other: 8-11% body weight decrease observed at 540 mg/kg/day

Dose descriptor:

NOEC

Effect level:

540 mg/kg bw/day

Sex:

female

Basis for effect level:

other: decreased body weight noted at 750 mg/kg/day

Dose descriptor:

NOEL

Remarks:

reproductive effects

Effect level:

750 mg/kg bw/day (nominal)

Sex:

male/female

Basis for effect level:

other: highest dose examined

Critical effects observed:

no

Dose descriptor:

NOEL

Generation:

other: F1a, F1b and F2 offspring

Effect level:

750 mg/kg bw/day (nominal)

Sex:

male/female

Basis for effect level:

other: no effects at highest dose examined

Critical effects observed:

no

Reproductive effects observed:

no

Effect on fertility: via oral route

Endpoint conclusion:

no adverse effect observed

Study duration:

subchronic

Species:

rat

Effect on fertility: via inhalation route

Endpoint conclusion:

no study available

Effect on fertility: via dermal route

Endpoint conclusion:

no study available

Justification for classification or non-classification

No adverse effects on fertility and developmental endpoints were observed in the two-generation reproduction toxicity study performed with the read-across source substance. Therefore, non-classification of the substance to be registered is justified.