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Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)

Data source

Reference
Reference Type:
secondary source
Title:
Letter From Monsanto Co To Usepa Regarding Toxicity Studies Of Dodecyl Phenol, With Attachments And Dated 5/22/96
Author:
Monsanto lab
Year:
1987
Bibliographic source:
OTS0532404

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
The teratology study of Dodecyl-Phenol
GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley

Administration / exposure

Route of administration:
oral: gavage
Type of inhalation exposure (if applicable):
not specified
Vehicle:
corn oil
Details on exposure:
Dodecylphenol was diluted in corn oil and given by qavage to five groups of five mated female Sprague-Dawley rat. at dosage. of 125 ,250,500, 1000, and 2000 mg/kq/day on days 6-15 of gestation.
Duration of treatment / exposure:
10 days(days 6-15 of gestation)
Frequency of treatment:
twice daily
Duration of test:
20 days
No. of animals per sex per dose:
25
Control animals:
not specified

Examinations

Maternal examinations:
-Rats were observed twice daily for mortality and signs of toxicity on days 6 through 15 of gestation. -Necropsy and uterine examinations were performed on all surviving females on gestation day 20.

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Maternal toxic effects:yesDetails on maternal toxic effects:-Mean maternal body weight gain was reduced in the 500 mq/kg/day group during the treatment period.-Mean food consumptl0n Was reduced durlng the day 6-10 lnterval in the 125, 250 and 500 mg/kg/day groups.-One female each in the 500 and 1000 mg/kg/day groups had resorption of all uterine implants.-No malformations were found by external examinatlon of fetuses.-No fetuses were available for examination in the 1000 and 2000 mg/kq/day dose groups because of maternal deaths.

Effect levels (maternal animals)

Based on:
not specified
Remarks on result:
other: not specified

Maternal abnormalities

Abnormalities:
not specified
Description (incidence and severity):
not specified

Results (fetuses)

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

Effect levels (fetuses)

Dose descriptor:
NOAEL
Effect level:
500 mg/kg bw/day
Based on:
test mat.
Basis for effect level:
other: fetotoxicity
Remarks on result:
other: not specified

Fetal abnormalities

Abnormalities:
not specified
Description (incidence and severity):
not specified

Overall developmental toxicity

Developmental effects observed:
not specified
Treatment related:
not specified
Relation to maternal toxicity:
not specified
Dose response relationship:
not specified
Relevant for humans:
not specified

Applicant's summary and conclusion

Conclusions:
The NOAEL (no observed adversed effects level ) value of Dodecylphenol in Sprague-Dawley rats was observed at a dose of 500 mg/kg/day.
Executive summary:

There was some evidence of maternal toxiclty at the 125 mg/kg/day dose level. and hlgher levels all caused greater degrees of response. There was no evidence of fetotoxicity based on the results of this study, dose levels of 20, 100 and 500 mg/kg/day were chosen for the full teratology study.thus based on resutls i-Mean maternal body weight gain was reduced in the 500 mq/kg/day group during the treatment period.Mean food consumption Was reduced durlng the day 6-10 lnterval in the 125, 250 and 500 mg/kg/day groups.One female each in the 500 and 1000 mg/kg/day groups had resorption of all uterine implants.No malformations were found by external examinatlon of fetuses.