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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
Reference
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

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

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.

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
Reference
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

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

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.

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
Reference
Endpoint:
repeated dose toxicity: dermal
Data waiving:
other justification
Justification for data waiving:
other:
Critical effects observed:
not specified
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.