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Toxicological information

Toxicity to reproduction

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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.