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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Effects on fertility

Link to relevant study records
Reference
Endpoint:
toxicity to reproduction
Remarks:
other: Parent
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:
female
Route of administration:
oral: unspecified
Type of inhalation exposure (if applicable):
not specified
Vehicle:
not specified
Details on mating procedure:
female 4 week(s) pre-mating - 3 week(s) post-birth
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
4 Weeks
Control animals:
not specified
Clinical signs:
effects observed, treatment-related
Toxic Effects : ve - Fertility - mating performance (e.g. # sperm positive females per # females mated; # copulations per # estrus cycles) Reproductive - Specific Developmental Abnormalities - urogenital system
Dose descriptor:
LOEL
Effect level:
35 000 mg/kg bw (total dose)
Based on:
test mat.
Sex:
female
Basis for effect level:
other: see 'Remark'
Clinical signs:
effects observed, treatment-related
Reproductive - Effects on Newborn - delayed effects
Reproductive effects observed:
not specified
Conclusions:
The one generation reproductive toxicity LOEL (Lowest observed effect level)of tert-butyl-4-methoxyphenol was observed at a dose concentration of 35000 mg/kg bw (total dose) in a 4 week period was given to female 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 one generation reproductive toxicity LOEL (Lowest observed effect level) of tert-butyl-4-methoxyphenol was observed at a dose concentration of 35000 mg/kg bw (total dose) in a 4 week period was given to female 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.

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
35 000 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Additional information
Short description of key information:
The one generation reproductive toxicity LOEL (Lowest observed effect level)of tert-butyl-4-methoxyphenol was observed at a dose concentration of 35000 mg/kg bw (total dose) in a 4 week period was given to female 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.

Justification for selection of Effect on fertility via oral route:
LOEL value of tert-butyl-4-methoxyphenol observed was 35000 mg/kg bw/day therefore NOAEL value of tert-butyl-4-methoxyphenol is bound to be less than 35000 mg/kg bw/day.

Effects on developmental toxicity

Description of key information
The toxicity (TDLo) of tert-butyl-4-methoxyphenol was tested in male/female rats by oral route shows effects as Reproductive - Effects on Newborn - growth statistics (e.g.%, reduced weight gain). ; if  the dose concentration reaches upto 30000 mg/kg bw (total dose).
Link to relevant study records
Reference
Endpoint:
developmental toxicity
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
Route of administration:
oral: unspecified
Type of inhalation exposure (if applicable):
not specified
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Details on mating procedure:
male 2 week(s) pre-mating female 2 week(s) pre-mating - 2 week(s) post-birth
Duration of treatment / exposure:
2 week
Control animals:
not specified
Dose descriptor:
LOEL
Effect level:
30 000 mg/kg bw (total dose)
Based on:
test mat.
Basis for effect level:
other: developmental toxicity
Abnormalities:
not specified
Developmental effects observed:
not specified
Conclusions:
The toxicity (TDLo) of tert-butyl-4-methoxyphenol was tested in male/female rats by oral route shows effects as Reproductive - Effects on Newborn - growth statistics (e.g.%, reduced weight gain). ; if the dose concentration reaches upto 30000 mg/kg bw (total dose).
Executive summary:

The toxicity (TDLo) of tert-butyl-4-methoxyphenol was tested in male/female rats by oral route shows effects as Reproductive - Effects on Newborn - growth statistics (e.g.%, reduced weight gain). ; if the dose concentration reaches upto 30000 mg/kg bw (total dose).

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
30 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Additional information
Justification for selection of Effect on developmental toxicity: via oral route:
The toxicity (TDLo) of tert-butyl-4-methoxyphenol was tested in male/female rats by oral route shows effects as Reproductive - Effects on Newborn - growth statistics (e.g.%, reduced weight gain). ; if the dose concentration reaches upto 30000 mg/kg bw (total dose).

Justification for classification or non-classification

Additional information