Registration Dossier

Administrative data

Endpoint:
hydrolysis
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
other information

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test material

Reference
Name:
Unnamed
Type:
Constituent

Study design

Estimation method (if used):
comparison with the behavior of structurally related compound

Results and discussion

Dissipation DT50 of parent compoundopen allclose all
pH:
4
Temp.:
25 °C
DT50:
> 1 yr
Remarks on result:
other: estimation
pH:
7
Temp.:
25 °C
DT50:
> 1 yr
Remarks on result:
other: estimation
pH:
9
Temp.:
25 °C
DT50:
> 1 yr
Remarks on result:
other: estimation

Any other information on results incl. tables

Test substance (ZK 39211)

rac-5-Amino-N-(2,3-dihydroxypropyl)-2,4,6-triiodoisophthalamic acid

Analogous compound (ZK 39166)

 

rac-N-(2,3-Dihydroxypropyl)-5-nitroisophthalamic acid

Kinetic data for hydrolysis of ZK 39166 at25°C(Report A01762):

pH

statement

half-life,t½

 

4

7

9

stable*

stable*

stable*

> 1 year

> 1 year

> 1 year

 

* “Stable” signifies that less than 10 % of the test substance were degraded during 5 days at 50 °C, corresponding to a half-life > 1 year at 25 °C.

Applicant's summary and conclusion

Executive summary:

On basis of the structural similarity of the test substance ZK 39211 with ZK 39166 (bears a nitro- instead of a amino-group at the benzene ring) hydrolytic stability is expected.

The rate of hydrolysis of ZK 39166 was determined according to EC guideline C.7 at pH 4, 7 and 9.

No hydrolytic degradation occured within 5 days at pH 4, 7 and 9 at 50 +/- 0.1 °C.

According to the EC test guideline, ZK 39166 can therefore be considered hydrolytically stable at pH 4, 7 and 9 (t½ > 1 year at 25 °C).