Registration Dossier
Registration Dossier
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EC number: 213-911-5 | CAS number: 1066-33-7
Epidemiological data
Administrative data
- Endpoint:
- epidemiological data
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable publication which meets basic scientific principles
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Three common Australian cough mixtures: A study of their use in pregnancy
- Author:
- Colley DP, Kay J and Gibson GT
- Year:
- 1 982
- Bibliographic source:
- Aust. J. Pharm, 63, 213-217
- Reference Type:
- publication
- Title:
- SIDS Initial Assessment Report For SIAM 22
- Author:
- OECD
- Year:
- 2 006
- Bibliographic source:
- OECD SIDS AMMONIUM BICARBONATE
Materials and methods
- Study type:
- cohort study (retrospective)
- Endpoint addressed:
- developmental toxicity / teratogenicity
Test guideline
- Qualifier:
- no guideline available
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Cough mixtures
- IUPAC Name:
- Cough mixtures
- Details on test material:
- - Test substance: Senega and Ammonia mixture Ammonium bicarbonate, liquorice and Senega extracts with chloroform water as preservative
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Details on study design:
- HYPOTHESIS TESTED (if cohort or case control study):
maternal use of three cough preparations including ammonia mixture versus neonatal outcomes
METHOD OF DATA COLLECTION
- Type: Record review
- Details: reevaluation of data set used in former publication by Nelson et al (Br. Med. J., 1971, 1 :523)
STUDY PERIOD: Between January 1978 and November 1980
STUDY POPULATION
- Total population (Total no. of persons in cohort from which the subjects were drawn): 137
- Selection criteria: neonatal outcome in different stages of pregnancy
- Total number of subjects participating in study: 6408 - Exposure assessment:
- not specified
Results and discussion
- Results:
- INCIDENCE / CASES
The proportion of adverse neonatal outcomes in relation to maternal use of Senega and Ammonia mixture in pregnancy was as follow::
- Premature birth (before 37 weeks): N = 8; 5.9% (N = 8); control: 6.7% ( N = 421)
- Low birth weight (2500 g or less): 9% (N = 12); control: 6.7% (N= 417)
- Pour Apgar score at 1 min (4 or less): 9.6% (N = 13); control: 6.1% (N=377)
- Congenital abnormalities: 4.4% (N = 6); control: 4.6% (N= 291)
- Perinatal deaths: 0.7% (N = 1); control: 1.5% (N = 94)
- Intrauterine growth retardation: 2.9% (N = 4); control: 1.2% (N = 77) - Strengths and weaknesses:
- Although not statistically significant, elevation in the rate for low birth weight and pour Apgar score is observed. An examination of individual cases showed seven (58%) of the low birth weight babies and four (31%) of the pour Apgar score babies were premature (< 37 weeks). The mother of two (50%) of the growth retarded babies smoked more than 20 cigarettes per day. These factors cast doubt on any association with Senega and ammonia mixture.
Any other information on results incl. tables
The absorption of cough medicine containing ammonium bicarbonate during pregnancy is not related to birth abnormalities.
Applicant's summary and conclusion
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