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

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

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

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

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

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 d

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.7

Max. score:

3

Reversibility:

fully reversible within: 7 d

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 d

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

In the in vivo skin and eye irritation studies performed with the read-across source substance in rabbits only a low irritation potential was observed on skin and eyes. However, the substance is classified on a harmonised base: skin irritation 2 and eye irritation 2 (Regulation 1272/2008). This classification will be applied to the substance to be registered.