Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Link to relevant study records
Reference
Endpoint:
one-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:
The prediction is done by using QSAR Toolbox Version 3.1

GLP compliance:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Route of administration:
oral: unspecified
Type of inhalation exposure (if applicable):
not specified
Vehicle:
not specified
Duration of treatment / exposure:
no data
Dose descriptor:
LOEL
Effect level:
54.125 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Reproductive effects observed:
not specified





The prediction was based on dataset comprised from the following descriptors: LOEL
Estimation method: Takes 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: C(=O)(O)CC(=O)CC(=O)O
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 OECD

Domain logical expression index: "c"

Referential boundary: The target chemical should be classified as SN2 OR SN2 >> SN2 reaction at sp3 carbon atom OR SN2 >> SN2 reaction at sp3 carbon atom >> Phosphates by Protein binding by OECD

Domain logical expression index: "d"

Parametric boundary:The target chemical should have a value of log Kow which is >= -4.82

Domain logical expression index: "e"

Parametric boundary:The target chemical should have a value of log Kow which is <= 2.37

Conclusions:
In reproductive toxicity study LOEL (Low observed effect level) of 3-oxoglutaric acid in male and female rat by the oral route was estimated using QSAR toolbox at a dose concentration of 54.12 mg/kg/day.This indicates that 3-oxoglutaric acid shall not exhibit any toxic effect to rat by the oral route below the above mentioned dose
Executive summary:

In reproductive toxicity study LOEL (Low observed effect level) of 3-oxoglutaric acid in male and female rat by the oral route was estimated using QSAR toolbox at a dose concentration of 54.12 mg/kg/day.This indicates that 3-oxoglutaric acid shall not exhibit any toxic effect to rat by the oral route below the above mentioned dose

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Species:
rat
Additional information
Short description of key information:
In reproductive toxicity study LOEL (Low observed effect level) of 3-oxoglutaric acid in male and female rat by the oral route was estimated using QSAR toolbox at a dose concentration of 54.12 mg/kg/day.This indicates that 3-oxoglutaric acid shall not exhibit any toxic effect to rat by the oral route below the above mentioned dose

Justification for selection of Effect on fertility via oral route:
Model considered relaible by OECD. In reproductive toxicity study LOEL (Low observed effect level) of 3-oxoglutaric acid in male and female rat by the oral route was estimated using QSAR toolbox at a dose concentration of 54.12 mg/kg/day.

Justification for classification or non-classification

In reproductive toxicity study LOEL (Low observed effect level) of 3-oxoglutaric acid in male and female rat by the oral route was estimated using QSAR toolbox at a dose concentration of 54.12 mg/kg/day.This indicates that 3-oxoglutaric acid shall not exhibit any toxic effect to rat by the oral route below the above mentioned dose. Also, there are studies which indicate that glutaric acid (that is a robust read across for 3 -oxoglutaric acid) does not exhibit repro-toxic effect in low concentrations. Thus, it is not classified as a repro-toxic chemical at the dose levels mentioned in the end points of toxicity to reproduction.

Additional information