Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Toxicity to reproduction

Currently viewing:

Administrative data

Endpoint:
toxicity to reproduction
Remarks:
other: Parent
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
review article or handbook
Title:
RTECS Number: SL1945000
Author:
RTECS Database
Year:
2012
Bibliographic source:
RTECS (Registry of Toxic Effects of Chemical Substances) : TXCYAC Toxicology. (Elsevier Scientific Pub. Ireland, Ltd., POB 85, Limerick, Ireland) V.1- 1973- Volume(issue)/page/year: 208,49,2005

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other:
Principles of method if other than guideline:
Data is from RTECS database
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
2-tert-butyl-4-methoxyphenol
EC Number:
204-442-7
EC Name:
2-tert-butyl-4-methoxyphenol
Cas Number:
121-00-6
Molecular formula:
C11H16O2
IUPAC Name:
2-tert-butyl-4-methoxyphenol
Details on test material:
- Name of test material (as cited in study report): tert-butyl-4-methoxyphenol
- Substance type: Organic
- Physical state: Solid

Test animals

Species:
rat
Strain:
not specified
Sex:
female

Administration / exposure

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

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:
effects observed, treatment-related

Details on results (P0)

Toxic Effects : ve - Fertility - mating performance (e.g. # sperm positive females per # females mated; # copulations per # estrus cycles) Reproductive - Specific Developmental Abnormalities - urogenital system

Effect levels (P0)

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'

Results: F1 generation

General toxicity (F1)

Clinical signs:
effects observed, treatment-related

Details on results (F1)

Reproductive - Effects on Newborn - delayed effects

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion

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.