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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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