Registration Dossier
Registration Dossier
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EC number: 211-059-9 | CAS number: 628-89-7
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: National Toxicology Programme Continuous Breeding Protocol
- Principles of method if other than guideline:
- Prediction is done using QSAR Toolbox version 2.3.
- GLP compliance:
- not specified
- Species:
- mouse
- Strain:
- CD-1
- Route of administration:
- oral: drinking water
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- not specified
- Control animals:
- not specified
- Dose descriptor:
- NOAEL
- Effect level:
- 1 526.667 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: not specified
- Remarks on result:
- other: Generation: fertility;P;F2 (migrated information)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Remarks on result:
- not measured/tested
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
- Conclusions:
- The two generation reproductive toxicity NOAEL (No observed adverse effect level) of 2-(2-chloroethoxy)ethanol in mouse(CD-1) by the oral route was observed at a dose concentration of 1526.666625977 mg/kgbw/day.
- Executive summary:
The two generation reproductive toxicity NOAEL (No observed adverse effect level) of 2-(2-chloroethoxy)ethanol in mouse(CD-1) by the oral route was estimated at a dose concentration of 1526.666625977 mg/kgbw/day. The estimation study inferes that no effect level has been observed for this substance and so 2-(2-chloroethoxy)ethanol will not have any impact on the reproductive toxicity of the species.
Reference
The
prediction was based on dataset comprised from the following
descriptors: NOAEL
Estimation method: Takes 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"
Referential
boundary: The
target chemical should be classified as Nonionic Surfactants by US-EPA
New Chemical Categories
Domain
logical expression index: "b"
Similarity
boundary:Target:
C(Cl)COCCO
Threshold=50%,
Dice(Atom centered fragments)
Domain
logical expression index: "c"
Similarity
boundary:Target:
C(Cl)COCCO
Threshold=50%,
Dice(Atom centered fragments)
Domain
logical expression index: "d"
Parametric
boundary:The
target chemical should have a value of log Kow which is >= -1.48
Domain
logical expression index: "e"
Parametric
boundary:The
target chemical should have a value of log Kow which is <= 0.569
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 526.666 mg/kg bw/day
- Study duration:
- subacute
- Species:
- mouse
- Quality of whole database:
- K2 level data obtained by estimation using QSAR modelling
Additional information
The two generation reproductive toxicity NOAEL (No observed adverse effect level) of 2-(2-chloroethoxy)ethanol in mouse(CD-1) by the oral route was estimated at a dose concentration of 1526.666625977 mg/kgbw/day. The estimation study inferes that no effect level has been observed for this substance and so 2-(2-chloroethoxy)ethanol will not have any impact on the reproductive toxicity of the species.
Justification for selection of Effect on fertility via oral route:
The estimation study inferes that no effect level has been observed for this substance and so 2-(2-chloroethoxy)ethanol will not have any impact on the reproductive toxicity of the species.
Effects on developmental toxicity
Link to relevant study records
- Endpoint:
- developmental toxicity
- 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:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Route of administration:
- oral: gavage
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Dose descriptor:
- NOAEL
- Effect level:
- 397.633 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: other:
- Remarks on result:
- other: not specified
- Abnormalities:
- not specified
- Localisation:
- not specified
- Description (incidence and severity):
- not specified
- Dose descriptor:
- other: not specified
- Based on:
- not specified
- Sex:
- not specified
- Basis for effect level:
- other: not specified
- 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 NOAEL (No observed adverse effect level) of 2-(2-chloroethoxy)ethanol in rat (Sprague-Dawley)by the oral route was observed at a dose concentration of 397.633331299 mg/kg bw/day.
- Executive summary:
The fetotoxicity NOAEL (No observed adverse effect level) of 2-(2-chloroethoxy)ethanol in rat (Sprague-Dawley) by the oral route was observed at a dose concentration of 397.633331299 mg/kg bw/day. This estimation do not indicate any adverse effect of the susbtance on reproduction and so will not be considered classification.
Reference
The
prediction was based on dataset comprised from the following
descriptors: NOAEL
Estimation method: Takes average value from the 5 nearest neighbours
Domain logical expression:Result: In Domain
(("a"
and "b" )
and ("c"
and "d" )
)
Domain
logical expression index: "a"
Referential
boundary: The
target chemical should be classified as Nonionic Surfactants by US-EPA
New Chemical Categories
Domain
logical expression index: "b"
Similarity
boundary:Target:
C(Cl)COCCO
Threshold=50%,
Dice(Atom centered fragments)
Domain
logical expression index: "c"
Parametric
boundary:The
target chemical should have a value of log Kow which is >= -1.46
Domain
logical expression index: "d"
Parametric
boundary:The
target chemical should have a value of log Kow which is <= 0.569
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 397.633 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- K2 level data obtained by estimation using QSAR modelling
Additional information
The fetotoxicity NOAEL (No observed adverse effect level) of 2-(2-chloroethoxy)ethanol in rat (Sprague-Dawley) by the oral route was observed at a dose concentration of 397.633331299 mg/kg bw/day. This estimation do not indicate any adverse effect of the susbtance on reproduction and so will not be considered classification.
Justification for selection of Effect on developmental toxicity: via oral route:
This estimation do not indicate any adverse effect of the susbtance on reproduction and so will not be considered classification.
Justification for classification or non-classification
The estimation performed for the reproductive toxicity and developmental toxicity, do not indicate any adverse effect of the susbtance on reproduction and so will not be considered 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.
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.
