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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

The substance tert-butyl-4-methoxyphenol relatively do not show  repeated dose toxicity by oral route.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
chronic 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:
Data is from RTECS database
GLP compliance:
not specified
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
6W
Frequency of treatment:
Continuous
Control animals:
not specified
Dose descriptor:
LOEL
Effect level:
63 000 mg/kg bw (total dose)
Based on:
test mat.
Sex:
not specified
Basis for effect level:
other: Overall effects : Toxic Effects : Endocrine - changes in adrenal weight Blood - changes in serum composition (e.g. TP, bilirubin, cholesterol)
Critical effects observed:
not specified
Conclusions:
The repeated dose toxicity LOEL (TDLo - Lowest published toxic dose) of tert-butyl-4-methoxyphenol was observed at a dose concentration of 63000 mg/kg bw (total dose) in a 6 weeks study period where the dosage of tert-butyl-4-methoxyphenol was continuously given to rats orally.This indicates that tert-butyl-4-methoxyphenol shall not exhibit toxic effect to rat by the oral route below the above mention dose.
Executive summary:

The repeated dose toxicity LOEL (TDLo - Lowest published toxic dose) of tert-butyl-4-methoxyphenol was observed at a dose concentration of 63000 mg/kg bw (total dose) in a 6 weeks study period where the dosage of tert-butyl-4-methoxyphenol was continuously given to rats orally.This indicates that tert-butyl-4-methoxyphenol shall not exhibit toxic effect to rat by the oral route below the above mention dose.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
63 000 mg/kg bw/day
Study duration:
chronic
Species:
rat

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:
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 3.2
GLP compliance:
not specified
Species:
rat
Strain:
Fischer 344
Sex:
not specified
Route of administration:
inhalation
Type of inhalation exposure:
not specified
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Dose descriptor:
LOEL
Effect level:
154.852 other: mg/kg bw/day
Based on:
test mat.
Sex:
not specified
Critical effects observed:
not specified





The prediction was based on dataset comprised from the following descriptors: "effect LOEL"
Estimation method: Taking average value from the 6 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 >= 2.61

Domain logical expression index: "d"

Parametric boundary:The target chemical should have a value of log Kow which is <= 4.2

Conclusions:
Repeated dose toxicity LOEL (Lowest observed effect level) of tert-butyl-4-methoxyphenol to rat by the inhalative route was observed at dose concentration of 154.8519 mg/kg bw/day.
Executive summary:
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Repeated dose toxicity LOEL (Lowest observed effect level) of tert-butyl-4-methoxyphenol to rat by the inhalative route was observed at dose concentration of 154.8519 mg/kg bw/day.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Species:
rat

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Repeated dose toxicity: oral

The repeated dose toxicity LOEL (TDLo - Lowest published toxic dose) of tert-butyl-4-methoxyphenol was observed at a dose concentration of 63000 mg/kg bw (total dose) in a 6 weeks study period where the dosage of tert-butyl-4-methoxyphenol was continuously given to rats orally.This indicates that tert-butyl-4-methoxyphenol shall not exhibit toxic effect to rat by the oral route below the above mention dose.

Repeated dose toxicity: inhalation

Repeated dose toxicity LOEL (Lowest observed effect level) of tert-butyl-4-methoxyphenol to rat by the inhalative route was observed at dose concentration of 154.8519 mg/m3 air.


Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
LOEL value of tert-butyl-4-methoxyphenol observed was 63000 mg/kg bw/day therefore NOAEL value of tert-butyl-4-methoxyphenol is bound to be less than 63000 mg/kg bw/day.

Justification for classification or non-classification