Registration Dossier
Registration Dossier
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EC number: 201-627-4 | CAS number: 85-73-4
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Link to relevant study records
- 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:
- oral: unspecified
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Remarks on result:
- not measured/tested
- Dose descriptor:
- LOEL
- Generation:
- F2
- Effect level:
- 108.742 other: mg/kg/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
- Conclusions:
- The two generation reproductive toxicity LOEL (Lowest observed effect level) of phthalylsulfathiazole in Rattus norvegicus was observed at a dose concentration of 108.7419 mg/kg/day.This indicates that phthalylsulfathiazole shall not exhibit toxic effect to Rattus norvegicus below the above mention dose.
- Executive summary:
The two generation reproductive toxicity LOEL (Lowest observed effect level) of phthalylsulfathiazole in Rattus norvegicus was observed at a dose concentration of 108.7419 mg/kg/day.This indicates that phthalylsulfathiazole shall not exhibit toxic effect to Rattus norvegicus below the above mention dose.
Reference
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" )
and "f" )
and ("g"
and (
not "h")
)
)
and ("i"
and (
not "j")
)
)
and ("k"
and "l" )
)
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 Not possible to classify
according to these rules by Protein Binding Potency
Domain
logical expression index: "c"
Referential
boundary: The
target chemical should be classified as 2-Chloroacetamides (SN2) OR
3-Alken-2-ones (MA) OR Alkyl 2-alkenoates (MA) OR Halogenated five
membered heterocycles (SN2) OR Halogenated hydrocarbons (SN2) OR Highly
reactive (GSH) OR Miscellaneous Alkyl 2-halo alkenoates (SN2) OR
Moderately reactive (GSH) OR Non-reactive (GSH) OR Substituted
1-Alken-3-ones (MA) by Protein Binding Potency
Domain
logical expression index: "d"
Referential
boundary: The
target chemical should be classified as No superfragment by
Superfragments
Domain
logical expression index: "e"
Referential
boundary: The
target chemical should be classified as High (Class III) by Toxic hazard
classification by Cramer (with extension)
Domain
logical expression index: "f"
Similarity
boundary:Target:
C(=O)(O)c1c(C(=O)Nc2ccc(S(=O)(=O)NC3=NC=CS3)cc2)cccc1
Threshold=60%,
Dice(Atom pairs)
Domain
logical expression index: "g"
Referential
boundary: The
target chemical should be classified as Non binder, without OH or NH2
group by Estrogen Receptor Binding
Domain
logical expression index: "h"
Referential
boundary: The
target chemical should be classified as Non binder, impaired OH or NH2
group OR Non binder, MW>500 by Estrogen Receptor Binding
Domain
logical expression index: "i"
Referential
boundary: The
target chemical should be classified as No alert found by DNA binding by
OECD
Domain
logical expression index: "j"
Referential
boundary: The
target chemical should be classified as Aliphatic tertiary amines OR
Arenes OR Aromatic nitro OR MA: Iminium Ion Formation OR MA: Nitrenium
Ion Formation OR MA: P450 Mediated Activation to Isocyanates or
Isothiocyanates OR MA: P450 Mediated Activation to Quinones and
Quinone-type Chemicals OR Mechanistic Domain: Acyalation OR Mechanistic
Domain: Michael addition OR Mechanistic Domain: SN1 OR Sulfonylureas by
DNA binding by OECD
Domain
logical expression index: "k"
Parametric
boundary:The
target chemical should have a value of log Kow which is >= 2
Domain
logical expression index: "l"
Parametric
boundary:The
target chemical should have a value of log Kow which is <= 3.48
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- 108.742 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- other: Rattus norvegicus
- Quality of whole database:
- K2 data from QSAR model considered relaible by OECD
Additional information
The two generation reproductive toxicity LOEL (Lowest observed effect level) of phthalylsulfathiazole in Rattus norvegicus was observed at a dose concentration of 108.7419 mg/kg/day.This indicates that phthalylsulfathiazole shall not exhibit toxic effect to Rattus norvegicus below the above mention dose.
Justification for selection of Effect on fertility via oral route:
The two generation reproductive toxicity LOEL (Lowest observed effect level) of phthalylsulfathiazole in Rattus norvegicus was observed at a dose concentration of 108.7419 mg/kg/day.
Effects on developmental toxicity
Description of key information
The substance phthalylsulfathiazole was found to be non toxic to reproduction.
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: 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
- Route of administration:
- oral: unspecified
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Remarks on result:
- not measured/tested
- Dose descriptor:
- LOEL
- Effect level:
- 441.95 other: mg/kg/day
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: fetotoxicity
- Remarks on result:
- other: not specified
- Abnormalities:
- not specified
- Localisation:
- other: not specified
- Description (incidence and severity):
- not specified
- Developmental effects observed:
- not specified
- Treatment related:
- not specified
- Conclusions:
- The fetotoxicity LOEL (Lowest observed effect level) of phthalylsulfathiazole in Rattus norvegicus by oral exposure was observed at a dose concentration of 441.9496 mg/kg/day .
- Executive summary:
The fetotoxicity LOEL (Lowest observed effect level) of phthalylsulfathiazole in Rattus norvegicus by oral exposure was observed at a dose concentration of 441.9496 mg/kg/day . This indicates that phthalylsulfathiazole shall not exhibit toxic effect to Rattus norvegicus by the oral route below the above mention dose.
Reference
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 ("d"
and (
not "e")
)
)
and ("f"
and (
not "g")
)
)
and ("h"
and "i" )
)
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"
Similarity
boundary:Target:
C(=O)(O)c1c(C(=O)Nc2ccc(S(=O)(=O)NC3=NC=CS3)cc2)cccc1
Threshold=60%,
Dice(Atom pairs)
Domain
logical expression index: "c"
Referential
boundary: The
target chemical should be classified as High (Class III) by Toxic hazard
classification by Cramer (with extension)
Domain
logical expression index: "d"
Referential
boundary: The
target chemical should be classified as Non binder, without OH or NH2
group by Estrogen Receptor Binding
Domain
logical expression index: "e"
Referential
boundary: The
target chemical should be classified as Non binder, impaired OH or NH2
group OR Non binder, MW>500 by Estrogen Receptor Binding
Domain
logical expression index: "f"
Referential
boundary: The
target chemical should be classified as No alert found by DNA binding by
OECD
Domain
logical expression index: "g"
Referential
boundary: The
target chemical should be classified as Aliphatic halides OR Aliphatic
tertiary amines OR Arenes OR Aromatic nitro OR MA: Iminium Ion Formation
OR MA: Nitrenium Ion Formation OR MA: P450 Mediated Activation to
Isocyanates or Isothiocyanates OR MA: P450 Mediated Activation to
Quinones and Quinone-type Chemicals OR MA: SN2 at an sp3 Carbon atom OR
Mechanistic Domain: Acyalation OR Mechanistic Domain: Michael addition
OR Mechanistic Domain: SN1 OR Mechanistic Domain: SN2 OR Sulfonylureas
OR Tertiary aromatic amine by DNA binding by OECD
Domain
logical expression index: "h"
Parametric
boundary:The
target chemical should have a value of log Kow which is >= 2.55
Domain
logical expression index: "i"
Parametric
boundary:The
target chemical should have a value of log Kow which is <= 3.12
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- 441.95 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- other: Rattus norvegicus
- Quality of whole database:
- K2 data from QSAR model considered relaible by OECD
Additional information
The fetotoxicity LOEL (Lowest observed effect level) of phthalylsulfathiazole in Rattus norvegicus by oral exposure was observed at a dose concentration of 441.9496 mg/kg/day . This indicates that phthalylsulfathiazole shall not exhibit toxic effect to Rattus norvegicus by the oral route below the above mention dose.
Justification for selection of Effect on developmental toxicity: via oral route:
The fetotoxicity LOEL (Lowest observed effect level) of phthalylsulfathiazole in Rattus norvegicus by oral exposure was observed at a dose concentration of 441.9496 mg/kg/day .
Justification for classification or non-classification
The LOEL values (Lowest observed effect level) of phthalylsulfathiazole on animals indicate that phthalylsulfathiazole shall not exhibit toxic effect to reproduction.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
