Registration Dossier
Registration Dossier
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EC number: 226-501-6 | CAS number: 5413-60-5
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Link to relevant study records
- Endpoint:
- toxicity to reproduction
- Remarks:
- other: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- Data is from QSAR database
- GLP compliance:
- not specified
- Species:
- other: human
- 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
- Control animals:
- not specified
- Dose descriptor:
- other: Relative ERBA
- Effect level:
- 0.015
- Based on:
- test mat.
- Sex:
- not specified
- Remarks on result:
- other: Generation not specified (migrated information)
- Reproductive effects observed:
- not specified
Reference
Effect on fertility: via dermal route
- Endpoint conclusion:
- no adverse effect observed
Additional information
The toxicity value for the target substance was not obtained for reproduction end point and so the same have been considered for a read across substance. The toxicity (TDLo - Lowest published toxic dose) of phenyl-p-benzoquinone was tested in female rats by subcutaneous route shows effects as Reproductive - Maternal Effects - ovaries, fallopian tubes; if the dose concentration reaches upto 5 mg/kg bw (total dose).
Effects on developmental toxicity
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- (Q)SAR
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Justification for type of information:
- QSAR prediction: migrated from IUCLID 5.6
- Qualifier:
- according to guideline
- Guideline:
- other: estimation
- Principles of method if other than guideline:
- QSAR estimation model
- GLP compliance:
- no
- Limit test:
- yes
- Species:
- other: Oryctolagus cuniculus;Rattus norvegicus
- Route of administration:
- oral: unspecified
- Vehicle:
- unchanged (no vehicle)
- Dose descriptor:
- LOEL
- Effect level:
- 181.017 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: fetotoxicity
- Abnormalities:
- not specified
- Developmental effects observed:
- not specified
- Conclusions:
- As per this predictiont the value does not classify substance for developmetal toxicity which can be considered for REACH regulation. Also the predicted values is within the domain so can be considered as more optimistic value.
- Executive summary:
The estimated value was obtained using the QSAR modelling approach, version 2.3. The predicted lethal dose was extimated to be 181 mg/kg/day. The calculation was performed out using the 8 nearest analog and the species being Oryctolagus cuniculus and Rattus norvegicus. As per this predictiont the value does not classify substance for developmetal toxicity which can be considered for
REACH regulation. Also the predicted values is within the domain so can be considered as more optimistic value.
Reference
The prediction was based on dataset comprised from the following descriptors: LOEL
Estimation method: Taking average value from the 8 nearest neighbours
Domain logical expression:Result: In Domain
(("a" and "b" ) and ("c" and "d" ) )
Domain logical expression index: "a"
Similarity boundary:Target: C(C)(=O)OC1C2C3C(C=CC3)C(C2)C1
Threshold=50%,
Dice(Atom pairs)
Domain logical expression index: "b"
Similarity boundary:Target: C(C)(=O)OC1C2C3C(C=CC3)C(C2)C1
Threshold=60%,
Dice(Atom pairs)
Domain logical expression index: "c"
Parametric boundary:The target chemical should have a value of log Kow which is >= 2.56
Domain logical expression index: "d"
Parametric boundary:The target chemical should have a value of log Kow which is <= 3.04
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LOAEL
- 181 mg/kg bw/day
- Study duration:
- subacute
- Species:
- mouse
Additional information
The estimated value was obtained using the QSAR modelling approach, version 2.3. The predicted lethal dose was extimated to be 181 mg/kg/day. The calculation was performed out using the 8 nearest analog and the species being Oryctolagus cuniculus and Rattus norvegicus. As per this predictiont the value does not classify substance for developmetal toxicity which can be considered for REACH regulation. Also the predicted values is within the domain so can be considered as more optimistic value.
Justification for classification or non-classification
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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