Registration Dossier
Registration Dossier
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EC number: 204-442-7 | CAS number: 121-00-6
Endpoint summary
Administrative data
Description of key information
Toxicity of tert-butyl-4-methoxyphenol in any of the routes have been distinctly observed.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- Standard acute method
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Species:
- mouse
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Control animals:
- not specified
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 1 100 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Toxic Effects : Behavioral - altered sleep time (including change in righting reflex) Behavioral - ataxia Lungs, Thorax, or Respiration - respiratory stimulation
- Mortality:
- Lethal dose, 50 percent kill
- Clinical signs:
- other: Toxic Effects : Behavioral - altered sleep time (including change in righting reflex) Behavioral - ataxia Lungs, Thorax, or Respiration - respiratory stimulation
- Interpretation of results:
- Toxicity Category IV
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral median lethal dose (LD50) of tert-butyl-4-methoxyphenol in mouse was found to be 1100 mg/kg of body weight. Acute oral toxicity of tert-butyl-4-methoxyphenol to mouse by oral route indicates that tert-butyl-4-methoxyphenol exhibits acute toxicity by the oral route in the Category 4 which is relatively non toxic.
- Executive summary:
The acute oral median lethal dose (LD50) of tert-butyl-4-methoxyphenol in mouse was found to be 1100 mg/kg of body weight. Acute oral toxicity of tert-butyl-4-methoxyphenol to mouse by oral route indicates that tert-butyl-4-methoxyphenol exhibits acute toxicity by the oral route in the Category 4 which is relatively non toxic.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 100 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- 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:
- Principles of method if other than guideline:
- Data is from QSAR toolbox Version 2.3
- GLP compliance:
- not specified
- Test type:
- other: Acute Rodent Inhalation Toxicity Test
- Species:
- mouse
- Strain:
- other: Swiss Webster
- Sex:
- not specified
- Route of administration:
- inhalation
- Type of inhalation exposure:
- other: Inhalation: Vapor
- Vehicle:
- not specified
- Control animals:
- not specified
- Sex:
- not specified
- Dose descriptor:
- LC50
- Effect level:
- 240.263 ppm
- Based on:
- test mat.
- Remarks on result:
- other: Other details not available
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Inhalation toxicity (LC50) of tert-butyl-4-methoxyphenol was examined in mouse at a dose concentration of 240.2633 mg/l.This value suggest that the chemical is non toxic by inhalation route.
- Executive summary:
</font> Inhalation toxicity (LC50) of tert-butyl-4-methoxyphenol was examined in mouse at a dose concentration of 240.2633 mg/l.This value suggest that the chemical is non toxic by inhalation route.
Reference
The
prediction was based on dataset comprised from the following
descriptors: LC50
Estimation method: Taking 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"
Similarity
boundary:Target:
C(C)(C)(C)c1c(O)ccc(OC)c1
Threshold=50%,
Dice(Atom pairs)
Domain
logical expression index: "b"
Similarity
boundary:Target:
C(C)(C)(C)c1c(O)ccc(OC)c1
Threshold=60%,
Dice(Atom pairs)
Domain
logical expression index: "c"
Parametric
boundary:The
target chemical should have a value of log Kow which is >= 1.61
Domain
logical expression index: "d"
Parametric
boundary:The
target chemical should have a value of log Kow which is <= 4.45
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 240.263 mg/m³ air
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- Data from USEPA report
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- male/female
- Type of coverage:
- not specified
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- other: eye makeup preparation containing 0.1% BHA
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the LD50 value of >2000 mg/kg for rabbit avaialble for tert-butyl-4-methoxyphenol, tt can be concluded that tert-butyl-4-methoxyphenol is not toxic via dermal route
- Executive summary:
Based on the LD50 value of >2000 mg/kg for rabbit avaialble for tert-butyl-4-methoxyphenol, it can be concluded that tert-butyl-4-methoxyphenol is not toxic via dermal route
Reference
Acute dermal testing rabbits of an eye makeup preparation containing 0.1% BHA yielded an LD50 > 2000 mg/kg.
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Dose descriptor:
- LD50
- Value:
- 2 100 mg/kg bw
Additional information
Acute toxicity: oral
The acute oral median lethal dose (LD50) of tert-butyl-4-methoxyphenol in rat was found to be 2000mg/kg of body weight.Acute oral toxicity of tert-butyl-4-methoxyphenol to rat by oral route indicates that tert-butyl-4-methoxyphenol exhibits acute toxicity by the oral route in the Category 4 which is relatively non toxic.
The other authoritative supporting sources of information also indicate the acute oral toxicity of tert-butyl-4-methoxyphenol to be in the range of 1100mg/kg of body weightto 2200mg/kg of body weight. However, for the purpose of the chemical safety report the experimental value will be considered.
Acute toxicity: inhalation
Inhalation toxicity (LC50) of tert-butyl-4-methoxyphenol was examined in mouse at a dose concentration of 240.2633 mg/m³ air.This value suggest that the chemical is non toxic by inhalation route.
Justification for selection of acute toxicity – oral endpoint
The acute oral median lethal dose (LD50) of tert-butyl-4-methoxyphenol in mouse was found to be 1100 mg/kg of body weight. Acute oral toxicity of tert-butyl-4-methoxyphenol to mouse by oral route indicates that tert-butyl-4-methoxyphenol exhibits acute toxicity by the oral route in the Category 4 which is relatively non toxic.
Justification for selection of acute toxicity – inhalation endpoint
Inhalation toxicity (LC50) of tert-butyl-4-methoxyphenol was examined in mouse at a dose concentration of 240.2633 mg/l.This value suggest that the chemical is non toxic by inhalation route.
Justification for selection of acute toxicity – dermal endpoint
Based on the LD50 value of >2000 mg/kg for rabbit avaialble for tert-butyl-4-methoxyphenol, it can be concluded that tert-butyl-4-methoxyphenol is not toxic via dermal route
Justification for classification or non-classification
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.
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