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Registration Dossier
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EC number: 211-059-9 | CAS number: 628-89-7
Endpoint summary
Administrative data
Description of key information
The substance 2-(2-chloroethoxy)ethanol 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:
- short-term repeated dose 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:
- other: F344/N;no data;Sprague-Dawley;COBS/CD;Fischer
- Sex:
- not specified
- Route of administration:
- other: no data
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Dose descriptor:
- LOEL
- Effect level:
- 1 448.108 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:
- This indicates that 2-(2-chloroethoxy)ethanol shall not exhibit toxic effect to rat by the oral route below the above mention dose.
- Executive summary:
The repeated dose toxicity LOEL (Lowest observed effect level) of 2-(2-chloroethoxy)ethanol in rat was observed at a dose concentration of 1448.108 mg/kg/day by the oral route.This indicates that 2-(2-chloroethoxy)ethanol shall not exhibit toxic effect to rat by the oral route below the above mention 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 (
not "d")
)
)
and ("e"
and "f" )
)
Domain
logical expression index: "a"
Similarity
boundary:Target:
C(Cl)COCCO
Threshold=50%,
Dice(Atom pairs)
Domain
logical expression index: "b"
Similarity
boundary:Target:
C(Cl)COCCO
Threshold=60%,
Dice(Atom pairs)
Domain
logical expression index: "c"
Referential
boundary: The
target chemical should be classified as No alert found by Protein
binding by OASIS
Domain
logical expression index: "d"
Referential
boundary: The
target chemical should be classified as Activated alkyl esters OR
alpha,beta-carbonyl compounds with polarized double bonds OR MA: Michael
addition on conjugated systems with electron withdrawing group OR MA:
Nucleophilic substitution at sp3 Carbon atom OR Mechanistic Domain:
Michael addition OR Mechanistic Domain: SN2 by Protein binding by OASIS
Domain
logical expression index: "e"
Parametric
boundary:The
target chemical should have a value of log Kow which is >= -0.679
Domain
logical expression index: "f"
Parametric
boundary:The
target chemical should have a value of log Kow which is <= 0.0763
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- 1 448.108 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- K2 data from QSAR model considered reliable by OECD
Repeated dose toxicity: inhalation - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: inhalation
- 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:
- other: Sprague-Dawley;F344;no data;F344/N;CFE
- Sex:
- not specified
- Route of administration:
- other: no data
- Type of inhalation exposure:
- not specified
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Dose descriptor:
- LOEL
- Effect level:
- 443.77 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
- System:
- other: not specified
- Organ:
- not specified
- Conclusions:
- This indicates that 2-(2-chloroethoxy)ethanol shall not exhibit toxic effect to rat by the inhilative route below the above mention dose.
- Executive summary:
The repeated dose toxicity LOEL (Lowest observed effect level) of 2-(2-chloroethoxy)ethanol in rat was observed at a dose concentration of 443.7696 mg/kg/day by the inhilative route.This indicates that 2-(2-chloroethoxy)ethanol shall not exhibit toxic effect to rat by the inhilative route below the above mention 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 (
not "d")
)
)
and ("e"
and "f" )
)
Domain
logical expression index: "a"
Similarity
boundary:Target:
C(Cl)COCCO
Threshold=50%,
Dice(Atom pairs)
Domain
logical expression index: "b"
Similarity
boundary:Target:
C(Cl)COCCO
Threshold=60%,
Dice(Atom pairs)
Domain
logical expression index: "c"
Referential
boundary: The
target chemical should be classified as No alert found by Protein
binding by OASIS
Domain
logical expression index: "d"
Referential
boundary: The
target chemical should be classified as Acid anhydride OR
alpha,beta-carbonyl compounds with polarized double bonds OR
alpha-activated haloalkanes OR Epoxides, Aziridines and Sulfuranes OR
MA: Direct acylation involving a leaving group OR MA: Michael addition
on conjugated systems with electron withdrawing group OR MA:
Nucleophilic substitution at sp3 Carbon atom OR MA: Ring opening SN2
reaction OR Mechanistic Domain: Acylation OR Mechanistic Domain: Michael
addition OR Mechanistic Domain: SN2 by Protein binding by OASIS
Domain
logical expression index: "e"
Parametric
boundary:The
target chemical should have a value of log Kow which is >= -0.49
Domain
logical expression index: "f"
Parametric
boundary:The
target chemical should have a value of log Kow which is <= 0.568
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- 443.77 mg/m³
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- K2 data from QSAR model considered reliable 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
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Repeated dose toxicity : Oral
The repeated dose toxicity LOEL (Lowest observed effect level) of 2-(2-chloroethoxy)ethanol in rat was observed at a dose concentration of 1448.108 mg/kg/day by the oral route.This indicates that 2-(2-chloroethoxy)ethanol shall not exhibit toxic effect to rat by the oral route below the above mention dose.
Repeated dose toxicity : Inhalation
The repeated dose toxicity LOEL (Lowest observed effect level) of 2-(2-chloroethoxy)ethanol in rat was observed at a dose concentration of 443.7696 mg/kg/day by the inhilative route.This indicates that 2-(2-chloroethoxy)ethanol shall not exhibit toxic effect to rat by the inhilative route below the above mention dose.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
The repeated dose toxicity LOEL (Lowest observed effect level) of 2-(2-chloroethoxy)ethanol in rat was observed at a dose concentration of 1448.108 mg/kg/day by the oral route.This indicates that 2-(2-chloroethoxy)ethanol shall not exhibit toxic effect to rat by the oral route below the above mention dose.
Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:
The repeated dose toxicity LOEL (Lowest observed effect level) of 2-(2-chloroethoxy)ethanol in rat was observed at a dose concentration of 443.7696 mg/kg/day by the inhilative route.This indicates that 2-(2-chloroethoxy)ethanol shall not exhibit toxic effect to rat by the inhilative route below the above mention dose.
Justification for selection of repeated dose toxicity dermal - systemic effects endpoint:
There are studies that indicate the acute dermal toxicity (LD50) of 2-(2-chloroethoxy)ethanol on guinea pig to be 3000 mg/kg body weight. Also, this chemical does not skin sensitization. Also dermal route of exposure is not the most dominant route when considering the intermediate use of this substance. In view of all the above, this end point was considered for waiver
Justification for classification or non-classification
The available studies indicate that 2-(2-chloroethoxy)ethanol is not classified as a repeated dose toxicity by oral and inhalation route.
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