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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
two-generation reproductive toxicity
Remarks:
based on test type (migrated information)
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
Sex:
male/female
Route of administration:
oral: unspecified
Type of inhalation exposure (if applicable):
not specified
Vehicle:
not specified
Duration of treatment / exposure:
10 weeks
Remarks:
Doses / Concentrations:
5,10 and 25 mg/kg/day
Basis:
no data
No. of animals per sex per dose:
25 male/female
Control animals:
not specified
Litter observations:
Decreased litter size
Dose descriptor:
LOEL
Generation:
F2
Effect level:
104.378 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: 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: c1(S(=O)(=O)CCO)ccc(NC(C)=O)cc1
Threshold=50%,
Dice(Atom pairs)

Domain logical expression index: "b"

Parametric boundary:The target chemical should have a value of log Kow which is >= -1.2

Domain logical expression index: "c"

Parametric boundary:The target chemical should have a value of log Kow which is <= 0.0487

Conclusions:
The two generation reproductive toxicity LOEL (Lowest observed effect level) of N-[4-[(2-hydroxyethyl)sulphonyl]phenyl]acetamide in Rattus norvegicus was observed at a dose concentration of 104.378 mg/kg bw/day.This indicates that N-[4-[(2-hydroxyethyl)sulphonyl]phenyl]acetamide 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 N-[4-[(2-hydroxyethyl)sulphonyl]phenyl]acetamide in Rattus norvegicus was observed at a dose concentration of 104.378 mg/kg bw/day.This indicates thatN-[4-[(2-hydroxyethyl)sulphonyl]phenyl]acetamide shall not exhibit toxic effect to Rattus norvegicus below the above mention dose.

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
104.378 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Quality of whole database:
K2 level data has been obtained from QSAR model considered by OECD.
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

Toxicity to reproduction

The two generation reproductive toxicity LOEL (Lowest observed effect level) of N-[4-[(2-hydroxyethyl)sulphonyl]phenyl]acetamide in Rattus norvegicus was observed at a dose concentration of 104.378 mg/kg bw/day.This indicates that N-[4-[(2-hydroxyethyl)sulphonyl]phenyl]acetamide shall not exhibit toxic effect to Rattus norvegicus below the above mention dose.


Short description of key information:
Study indicates that N-[4-[(2-hydroxyethyl)sulphonyl]phenyl]acetamide shall not exhibit toxic effect to Rattus norvegicus.

Justification for selection of Effect on fertility via oral route:
The two generation reproductive toxicity LOEL (Lowest observed effect level) of N-[4-[(2-hydroxyethyl)sulphonyl]phenyl]acetamide in Rattus norvegicus was observed at a dose concentration of 104.378 mg/kg bw/day.This indicates that N-[4-[(2-hydroxyethyl)sulphonyl]phenyl]acetamide shall not exhibit toxic effect to Rattus norvegicus below the above mention dose.

Effects on developmental toxicity

Description of key information
LOEL of N-[4-[(2-hydroxyethyl)sulphonyl]phenyl]acetamide was estimated to be 49.93153 mg/kg bw/day.
Link to relevant study records
Reference
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
Duration of treatment / exposure:
10 days
Remarks:
Doses / Concentrations:
5,10 and 25 mg/kg/day
Basis:
no data
No. of animals per sex per dose:
25 female
Control animals:
not specified
Dose descriptor:
LOEL
Effect level:
49.932 mg/kg bw/day
Based on:
test mat.
Basis for effect level:
other: fetotoxicity
Abnormalities:
not specified
Developmental effects observed:
not specified





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" ) )

Domain logical expression index: "a"

Similarity boundary:Target: c1(S(=O)(=O)CCO)ccc(NC(C)=O)cc1
Threshold=50%,
Dice(Atom pairs)

Domain logical expression index: "b"

Parametric boundary:The target chemical should have a value of log Kow which is >= -1.1

Domain logical expression index: "c"

Parametric boundary:The target chemical should have a value of log Kow which is <= 0.0486

Conclusions:
The fetotoxicity LOEL (Lowest observed effect level) of N-[4-[(2-hydroxyethyl)sulphonyl]phenyl]acetamide in Rattus norvegicus by oral exposure was observed at a dose concentration of 49.93153 mg/kg bw/day . This indicates that N-[4-[(2-hydroxyethyl)sulphonyl]phenyl]acetamide shall not exhibit toxic effect to Rattus norvegicus by the oral route below the above mention dose.
Executive summary:

The fetotoxicity LOEL (Lowest observed effect level) of N-[4-[(2-hydroxyethyl)sulphonyl]phenyl]acetamide in Rattus norvegicus by oral exposure was observed at a dose concentration of 49.93153 mg/kg bw/day . This indicates that N-[4-[(2-hydroxyethyl)sulphonyl]phenyl]acetamide shall not exhibit toxic effect to Rattus norvegicus by the oral route below the above mention dose.

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
49.932 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Quality of whole database:
K2 level data has been obtained from QSAR model considered by OECD.
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

Developmental toxicity / teratogenicity

The fetotoxicity LOEL (Lowest observed effect level) of N-[4-[(2-hydroxyethyl)sulphonyl]phenyl]acetamide in Rattus norvegicus by oral exposure was observed at a dose concentration of 49.93153 mg/kg bw/day . This indicates that N-[4-[(2-hydroxyethyl)sulphonyl]phenyl]acetamide 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 N-[4-[(2-hydroxyethyl)sulphonyl]phenyl]acetamide in Rattus norvegicus by oral exposure was observed at a dose concentration of 49.93153 mg/kg bw/day . This indicates that N-[4-[(2-hydroxyethyl)sulphonyl]phenyl]acetamide shall not exhibit toxic effect to Rattus norvegicus by the oral route below the above mention dose.

Justification for classification or non-classification

According to the available information the substance is not classified in reprotoxic category.

Additional information