Registration Dossier
Registration Dossier
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EC number: 202-675-9 | CAS number: 98-51-1
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- no data
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Abstract.
Data source
Reference
- Reference Type:
- publication
- Title:
- Long-lasting learning and memory impairments induced by prenatal exposure to 4-tert-butyltoluene in rats.
- Author:
- Hass U et al.
- Year:
- 1 996
- Bibliographic source:
- Teratology 53: 22A, abstract no. F15.
Materials and methods
- Principles of method if other than guideline:
- No data on method given.
- GLP compliance:
- not specified
- Limit test:
- yes
Test material
- Reference substance name:
- 4-tert-butyltoluene
- EC Number:
- 202-675-9
- EC Name:
- 4-tert-butyltoluene
- Cas Number:
- 98-51-1
- Molecular formula:
- C11H16
- IUPAC Name:
- 1-tert-butyl-4-methylbenzene
- Details on test material:
- - Name of test material (as cited in study report): 4-tert-butyltoluene
- Physical state: liquid
- Analytical purity: no data
No further data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
female Mol:WIST rats
no further data
ENVIRONMENTAL CONDITIONS: no data
IN-LIFE DATES: no data
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- not specified
- Details on exposure:
- No details given.
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- No details given.
- Duration of treatment / exposure:
- days 7 through 20 of gestation
- Frequency of treatment:
- 6 hours/day
- Duration of test:
- until 22 months after delivery
Doses / concentrations
- Remarks:
- Doses / Concentrations:
ca. 0.12 mg/l (20 ppm)
Basis:
nominal conc.
- No. of animals per sex per dose:
- no data
- Control animals:
- yes
- Details on study design:
- No further details given.
Examinations
- Maternal examinations:
- No details given.
- Statistics:
- No data.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Details on maternal toxic effects:
The dose level used, ca. 0.12 mg/l (20 ppm), did not induce maternal toxicity. No further data.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEC
- Effect level:
- > 0.12 mg/L air
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEC
- Effect level:
- > 0.12 mg/L air
- Basis for effect level:
- other: other:
- Remarks on result:
- not determinable
- Remarks:
- no NOAEC identified
- Dose descriptor:
- NOAEC
- Basis for effect level:
- other: developmental toxicity
- Remarks on result:
- not determinable
- Remarks:
- no NOAEC identified
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Details on embryotoxic / teratogenic effects:
The dose level used, ca. 0.12 mg/l (20 ppm), did not induce decreased viability of offspring.
Lowered pup body weight until day 10 and delayed ontogeny of reflexes - also after correction for body weight - was recorded.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
At
the age of 3 months, increased latencies and swim length were observed
in the learning period of treated female offspring (p = 0.6%). Three
weeks later, indications of memory impairments were noted. However,
these increases were not statistically significant (p = 8.7%). No
substance-related effects were observed at 17 months. At the age of 22
months, increases in latencies and swim length indicating memory
impairments were observed in the first 3 trials and in the trials
following a 4-days break in testing (p = 5.5%).
According to the authors, the impairment in exposed female offspring was
not considered to be related to poorer swimming capability since swim
lengths were increased in proportion to the increased latencies; swim
speed was similar to control. The results indicated that
substance-related neurobehavioral impairments could interact with the
consequences of aging.
Applicant's summary and conclusion
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