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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