Registration Dossier

Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1995-1997
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: We do not have the full report

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: EP/TSCA
Principles of method if other than guideline:
Doses of 0, 125, 500 and 2 000 mg/kg/d were given to groups of 24 mated females from day 6 to 15 of gestation.
Dams were terminated at gestation day 20 and foetuses were examined for external soft tissues and skeletal defects.
GLP compliance:
yes
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
The substance is a linear alkylbenzene - Molecular formula : C6H5CnH2n+1 with n = 10-13
Molecular weight : 239 - 243
Physical from : liquid

Test animals

Species:
rat
Strain:
CD-1
Details on test animals and environmental conditions:
no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on exposure:
daily treatment
Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
no data
Details on mating procedure:
no data
Duration of treatment / exposure:
10 days (from day 6 - to 15 of gestation) (daily doses)
Frequency of treatment:
daily doses
Duration of test:
20 days
No. of animals per sex per dose:
24
Control animals:
yes
Details on study design:
no data

Examinations

Maternal examinations:
Slight decrease in weight gain at 125 mg/kg/d which was not significant
At 500 and 2 000 mg/kg/d the decreases in weight gain were ; however compensatory increases in weight gain occured during the post-treatment
period.
Ovaries and uterine content:
no data
Fetal examinations:
At 2000 mg/kg/d ossification variations and delayed ossification increased significantly and were above control at 500 mg/kg/d
( 79.7 % of foetuses with variations and delated ossification and 57.3 % in the control group)
Statistics:
no data
Indices:
no data
Historical control data:
no data

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Maternal toxic effects:yes

Details on maternal toxic effects:
Slight decrease in maternel weight gain at 125 mg/kg/d which was not significant. Decreases in maternel weight gain at 500 and 2 000 mg/kg/d
which was compensated by a weight gain during the post-treatment period.

Effect levels (maternal animals)

Dose descriptor:
other: observation
Effect level:
ca. 2 000 mg/kg bw/day (nominal)
Based on:
test mat.
Basis for effect level:
other: developmental toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:no effects

Effect levels (fetuses)

Remarks on result:
not determinable due to absence of adverse toxic effects

Overall developmental toxicity

Developmental effects observed:
no

Applicant's summary and conclusion

Conclusions:
The substance should not be consiered as a developmental toxicant.
Executive summary:

In the study doses of 0, 125, 500 and 2 000 mg/kg/d of substance in corn oil were given to groups of 24 mated females from day 6 to 15 of gestation.

Dams were terminated at gestation day 20 and foetuses were examined for external soft tissues and skeletal defects.

There were no significant differences between control and treated groups in the number of foetuses with malformations.

The substance should not be considered as a developmental toxicant since an increased indicence of ossification variations and delayed ossification only at dose level causing maternal toxicity cannot be considered as specific effects on prenatal development.