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Registration Dossier
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EC number: 201-627-4 | CAS number: 85-73-4
Endpoint summary
Administrative data
Description of key information
The substance phthalylsulfathiazole is not toxic by oral and inhalation route through repeated dose.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: oral
- 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:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- not specified
- Route of administration:
- oral: unspecified
- Vehicle:
- unchanged (no vehicle)
- Dose descriptor:
- LOEL
- Effect level:
- 386.755 mg/kg bw/day (nominal)
- 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
- Conclusions:
- Repeated dose toxicity LOEL (Lowest observed effect level) of phthalylsulfathiazole in rat (Sprague-Dawley) by the oral route was estimated at a dose concentration of 386.7549 mg/kg/day.
- Executive summary:
Repeated dose toxicity LOEL (Lowest observed effect level) of phthalylsulfathiazole in rat (Sprague-Dawley) by the oral route was estimated at a dose concentration of 386.7549 mg/kg/day.On the basis of this LOEL value it is concluded that the test substance is not toxic to rat (Sprague-Dawley) by oral route below the above mentioned dose.
Reference
The
prediction was based on dataset comprised from the following
descriptors: "effect LOEL"
Estimation method: Taking average value from the 5 nearest neighbours
Domain logical expression:Result: In Domain
((("a"
and "b" )
and "c" )
and ("d"
and "e" )
)
Domain
logical expression index: "a"
Similarity
boundary:Target:
C(=O)(O)c1c(C(=O)Nc2ccc(S(=O)(=O)NC3=NC=CS3)cc2)cccc1
Threshold=50%,
Dice(Atom pairs)
Domain
logical expression index: "b"
Referential
boundary: The
target chemical should be classified as High (Class III) by Toxic hazard
classification by Cramer (original)
Domain
logical expression index: "c"
Referential
boundary: The
target chemical should be classified as No superfragment by
Superfragments
Domain
logical expression index: "d"
Parametric
boundary:The
target chemical should have a value of log Kow which is >= 2.41
Domain
logical expression index: "e"
Parametric
boundary:The
target chemical should have a value of log Kow which is <= 3.06
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- 386.755 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- K2 data from QSAR model considered relaible by OECD
Repeated dose toxicity: inhalation - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: inhalation
- 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: estimated data
- Principles of method if other than guideline:
- Prediction is done using QSAR Toolbox version 2.3.
- GLP compliance:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- not specified
- Route of administration:
- inhalation
- Type of inhalation exposure:
- not specified
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Dose descriptor:
- LOEL
- Effect level:
- 106.227 mg/kg bw/day (actual dose received)
- 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
- Organ:
- not specified
- Conclusions:
- Repeated dose toxicity LOEL (Lowest observed effect level) of phthalylsulfathiazole to rat (Sprague-Dawley)by the inhalation route was estimated at a dose concentration of 106.2268 mg/kg/day.
- Executive summary:
Repeated dose toxicity LOEL (Lowest observed effect level) of phthalylsulfathiazole to rat (Sprague-Dawley)by the inhalation route was estimated at a dose concentration of 106.2268 mg/kg/day. On the basis of this LOEL value it is concluded that the substance phthalylsulfathiazole is not toxic to rat (Sprague-Dawley) by inhalative route below the above mentioned dose.
Reference
The
prediction was based on dataset comprised from the following
descriptors: "effect LOEL"
Estimation method: Taking average value from the 5 nearest neighbours
Domain logical expression:Result: In Domain
("a"
and ("b"
and "c" )
)
Domain
logical expression index: "a"
Similarity
boundary:Target:
C(=O)(O)c1c(C(=O)Nc2ccc(S(=O)(=O)NC3=NC=CS3)cc2)cccc1
Threshold=50%,
Dice(Atom pairs)
Domain
logical expression index: "b"
Parametric
boundary:The
target chemical should have a value of log Kow which is >= -2.14
Domain
logical expression index: "c"
Parametric
boundary:The
target chemical should have a value of log Kow which is <= 4.85
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- 106.227
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- K2 data from QSAR model considered relaible by OECD
Repeated dose toxicity: dermal - systemic effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: dermal
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Critical effects observed:
- not specified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Repeated dose toxicity :
Repeated dose toxicity : Oral
Repeated dose toxicity LOEL (Lowest observed effect level) of phthalylsulfathiazole in rat (Sprague-Dawley) by the oral route was estimated at a dose concentration of 386.7549 mg/kg/day.On the basis of this LOEL value it is concluded that the test substance is not toxic to rat (Sprague- Dawley)by oral route below the above mentioned dose. The supporting studies showes TDLo - Lowest published toxic dose values for phthalylsulfathiazole also support the key study indicating non toxic behaviour of the substance.
Repeated dose toxicity : Inhalation
Repeated dose toxicity LOEL (Lowest observed effect level) of phthalylsulfathiazole to rat (Sprague-Dawley)by the inhalation route was estimated at a dose concentration of 106.2268 mg/kg/day.On the basis of this LOEL value it is concluded that the substance phthalylsulfathiazole is not toxic to rat (Sprague-Dawley) by inhalative route below the above mentioned dose.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Repeated dose toxicity LOEL (Lowest observed effect level) of phthalylsulfathiazole in rat (Sprague-Dawley) by the oral route was estimated at a dose concentration of 386.7549 mg/kg/day.On the basis of this LOEL value it is concluded that the test substance is not toxic to rat (Sprague-Dawley)by oral route below the above mentioned dose.
Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:
Repeated dose toxicity LOEL (Lowest observed effect level) of phthalylsulfathiazole to rat (Sprague-Dawley)by the inhalation route was estimated at a dose concentration of 106.2268 mg/kg/day.On the basis of this LOEL value it is concluded that the substance phthalylsulfathiazole is not toxic to rat (Sprague-Dawley) by inhalative route below the above mentioned dose.
Justification for selection of repeated dose toxicity dermal - systemic effects endpoint:
There are studies that indicate the acute dermal toxicity (LD50) of phthalylsulfathiazole on rat to be greater than 2000 mg/kg body weight. Also, this chemical does not show skin sensitization. Thus indicating that the substance will have negligible effect on dermal exposure and thus is not considered for furhter testing.
Justification for classification or non-classification
On the basis of this LOEL value it is concluded that the substance phthalylsulfathiazole is not toxic via inhalation and oral route. Also demal toxicity will be not considerd as acute toxicity is nil.
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