Registration Dossier
Registration Dossier
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EC number: 206-462-1 | CAS number: 345-78-8
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Abstract without raw data information.
Data source
Reference
- Reference Type:
- publication
- Title:
- Teratological evaluation in rat of SK&F 93944 administered alone or combined with pseudoephedrine HCl (P).
- Author:
- Freeman S.J.
- Year:
- 1 989
- Bibliographic source:
- The Toxicologist, Abstracts of the Annual Meeting, Vol.9, No.1, February/March 1989.
Materials and methods
- Principles of method if other than guideline:
- Pregnant Wistar rats received 240 mg/kg bw of Pseudoephedrine HCl (used as a control substance in the study) on days 6-15 of gestation. At least effects on dams body weight and food consumption and fetal weight and ossification were investigated.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Pseudoephedrine hydrochloride
- EC Number:
- 206-462-1
- EC Name:
- Pseudoephedrine hydrochloride
- Cas Number:
- 345-78-8
- Molecular formula:
- C10H15NO.ClH
- IUPAC Name:
- 2-(methylamino)-1-phenylpropan-1-ol hydrochloride
- Details on test material:
- - Name of test material (as cited in study report): pseudoephedrine HCl
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Day 6-15 of gestation
- Frequency of treatment:
- once daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
240 mg/kg bw
Basis:
actual ingested
Examinations
- Maternal examinations:
- At least effects on dams body weight and food consumption were investigated.
- Fetal examinations:
- At least effects on fetal weight and ossification were investigated.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Decreases in dam body weight and food consumption.
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
Deficits in fetal weight and ossification.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- A developmental toxicity effect of the test substance in rats cannot be ruled out, but may only occur at maternal toxic doses.
- Executive summary:
Pregnant Wistar rats received 240 mg/kg bw of Pseudoephedrine HCl (used as a control substance in the study) on days 6-15 of gestation. At least effects on dams body weight and food consumption and fetal weight and ossification were investigated. An influence of Pseudoephedrine HCl on the dams as well as on the fetuses is reported. Based on the available data, a developmental toxicity effect of the test substance in rats cannot be ruled out, but may only occur at maternal toxic doses.
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