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Administrative data

Key value for chemical safety assessment

Effects on fertility

Link to relevant study records
Reference
Endpoint:
two-generation reproductive toxicity
Remarks:
based on test type (migrated information)
Type of information:
(Q)SAR
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Justification for type of information:
QSAR prediction: migrated from IUCLID 5.6
Qualifier:
according to guideline
Guideline:
other: estimated data
Principles of method if other than guideline:
Prediction is done using QSAR Toolbox version 2.3.
GLP compliance:
no
Species:
other: Rattus norvegicus
Strain:
not specified
Sex:
not specified
Route of administration:
other: no data
Type of inhalation exposure (if applicable):
not specified
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Dose descriptor:
other: not specified
Based on:
not specified
Sex:
not specified
Basis for effect level:
other: not specified
Remarks on result:
other: not specified
Critical effects observed:
not specified
System:
other: not specified
Organ:
not specified
Dose descriptor:
LOEL
Generation:
F2
Effect level:
182.553 mg/kg bw/day
Based on:
test mat.
Sex:
not specified
Basis for effect level:
other: not specified
Remarks on result:
other: not specified
Critical effects observed:
not specified
System:
other: not specified
Organ:
not specified
Reproductive effects observed:
not specified
Treatment related:
not specified

The prediction was based on dataset comprised from the following descriptors: LOEL
Estimation method: Taking average value from the 5 nearest neighbours
Domain logical expression:Result: In Domain

((("a" and "b" ) and ("c" and ( not "d") ) ) and ("e" and "f" ) )

Domain logical expression index: "a"

Similarity boundary:Target: c1(I)c(O)c2c(c(I)c1)cccn2
Threshold=50%,
Dice(Atom pairs)

Domain logical expression index: "b"

Referential boundary: The target chemical should be classified as No superfragment by Superfragments

Domain logical expression index: "c"

Referential boundary: The target chemical should be classified as No alert found by Protein binding by OECD

Domain logical expression index: "d"

Referential boundary: The target chemical should be classified as Acetates OR MA: Direct Acylation Involving a Leaving group OR Mechanistic Domain: Acylation by Protein binding by OECD

Domain logical expression index: "e"

Parametric boundary:The target chemical should have a value of log Kow which is >= 3.29

Domain logical expression index: "f"

Parametric boundary:The target chemical should have a value of log Kow which is <= 4.01

Conclusions:
The two generation reproductive toxicity LOEL (Lowest observed effect level) of diiodohydroxyquinoline in Rattus norvegicus was observed at a dose concentration of 182.5526 mg/kg bw/day.This indicates that diiodohydroxyquinoline shall not exhibit toxic effect to Rattus norvegicus
below the above mentioned dose.
Executive summary:

The two generation reproductive toxicity LOEL (Lowest observed effect level) of diiodohydroxyquinoline in Rattus norvegicus was observed at a dose concentration of 182.5526 mg/kg bw/day.This indicates that diiodohydroxyquinoline shall not exhibit toxic effect to Rattus norvegicus

below the above mentioned dose.

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Additional information

Short description of key information:

The two generation reproductive toxicity LOEL (Lowest observed effect level) of diiodohydroxyquinoline in Rattus norvegicus was observed at a dose concentration of 182.5526 mg/kg bw/day.This indicates that diiodohydroxyquinoline shall not exhibit toxic effect to Rattus norvegicus

below the above mentioned dose. The other result also predicts the ERBA effect level to be equal to 0.075 which could be a possible pointer towards the chemical not being toxic to reproduction in low levels. Thus, the weight of evidence approach does not suggest reprotixicity within the concentration mentioned in the study results.

Justification for selection of Effect on fertility via oral route:

Model is considered relaible by OECD

Effects on developmental toxicity

Description of key information

The fetotoxicity LOEL (Lowest observed effect level) of diiodohydroxyquinoline in Rattus norvegicus and Oryctolagus cuniculus was observed at a dose concentration of 640.9886 mg/kg bw/day.This indicates that diiodohydroxyquinoline shall not exhibit toxic effect to Rattus norvegicus and Oryctolagus cuniculus below the above mentioned dose. The DAmish EPA database also attributes negative teratogenecity to diiodohydroxyquinoline in low concentrations.

Link to relevant study records
Reference
Endpoint:
developmental toxicity
Type of information:
(Q)SAR
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Justification for type of information:
QSAR prediction: migrated from IUCLID 5.6
Qualifier:
according to guideline
Guideline:
other: estimated data
Principles of method if other than guideline:
Prediction is done using QSAR Toolbox version 2.3.
GLP compliance:
no
Species:
other: Rattus norvegicus;Oryctolagus cuniculus
Strain:
not specified
Route of administration:
other: no data
Type of inhalation exposure (if applicable):
not specified
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Dose descriptor:
other: not specified
Based on:
not specified
Basis for effect level:
other: not specified
Remarks on result:
other: not specified
Abnormalities:
not specified
Localisation:
not specified
Description (incidence and severity):
not specified
Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:no data
Dose descriptor:
LOEL
Effect level:
640.989 mg/kg bw/day
Based on:
test mat.
Basis for effect level:
other: fetotoxicity
Abnormalities:
not specified
Localisation:
other: not specified
Description (incidence and severity):
not specified
Developmental effects observed:
not specified
Treatment related:
not specified

The prediction was based on dataset comprised from the following descriptors: LOEL
Estimation method: Taking average value from the 5 nearest neighbours
Domain logical expression:Result: In Domain

(("a" and ("b" and ( not "c") ) ) and ("d" and "e" ) )

Domain logical expression index: "a"

Similarity boundary:Target: c1(I)c(O)c2c(c(I)c1)cccn2
Threshold=50%,
Dice(Atom pairs)

Domain logical expression index: "b"

Referential boundary: The target chemical should be classified as No alert found by Protein binding by OASIS

Domain logical expression index: "c"

Referential boundary: The target chemical should be classified as alpha,beta-carbonyl compounds with polarized double bonds OR alpha-activated haloalkanes OR Carbamates OR MA: Direct acylation involving a leaving group OR MA: Michael addition on conjugated systems with electron withdrawing group OR MA: Nucleophilic substitution at sp3 Carbon atom OR MA: Pyrazolones and pyrazolidinones derivatives OR Mechanistic Domain: Acylation OR Mechanistic Domain: Michael addition OR Mechanistic Domain: Schiff base formation OR Mechanistic Domain: SN2 OR N-acylamides OR Pyrazolones and pyrazolidinones by Protein binding by OASIS

Domain logical expression index: "d"

Parametric boundary:The target chemical should have a value of log Kow which is >= 3.02

Domain logical expression index: "e"

Parametric boundary:The target chemical should have a value of log Kow which is <= 4.83

Conclusions:
The fetotoxicity LOEL (Lowest observed effect level) of diiodohydroxyquinoline in Rattus norvegicus and Oryctolagus cuniculus was observed at a dose concentration of 640.9886 mg/kg bw/day.This indicates that diiodohydroxyquinoline shall not exhibit toxic effect to Rattus norvegicus and Oryctolagus cuniculus below the above mentioned dose.
Executive summary:

The fetotoxicity LOEL (Lowest observed effect level) of diiodohydroxyquinoline in Rattus norvegicus and Oryctolagus cuniculus was observed at a dose concentration of 640.9886 mg/kg bw/day.This indicates that diiodohydroxyquinoline shall not exhibit toxic effect to Rattus norvegicus and Oryctolagus cuniculus below the above mentioned dose.

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Study duration:
chronic
Species:
rat
Quality of whole database:
Model considered relaible by OECD supported by data from the Danish EPA that is considered to be an authoritative source of information
Additional information

Justification for selection of Effect on developmental toxicity: via oral route:

Model considered relaible by OECD

Justification for classification or non-classification

Additional information