Reaction mass of sodium (methylbutyl and pentyl) sulfonate and sodium 1,2-bis(pentyloxycarbonyl)ethanesulphonate

Epidemiological data

Administrative data

Endpoint:

epidemiological data

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference 1

Reference Type:

review article or handbook

Title:

Birth Defects and Drugs in Pregnancy

Author:

Heinonen OP, Slone D, Shapiro S

Year:

1977

Bibliographic source:

Publishing Sciences Group, Inc., Littleton 1977 , pp 385 & 442

Reference 2

Reference Type:

review article or handbook

Title:

Toxicity profile Dioctyl Sodium Sulphosuccinate

Author:

Bibra Information Department, Woodmansterne Road Carshalton Surrey SM5 4DS Great Britain

Year:

1989

Reference 3

Reference Type:

review article or handbook

Title:

Treating constipation during pregnancy

Author:

Trottier M, Erebara A, Bozzo P

Year:

2012

Bibliographic source:

Can Fam Physician. 2012 Aug;58(8):836-8.

Materials and methods

Study type:

other: prospective study

Endpoint addressed:

developmental toxicity / teratogenicity

Test material

Test material information

Constituent 1

Reference substance name:

Docusate sodium

EC Number:

209-406-4

EC Name:

Docusate sodium

Cas Number:

577-11-7

Molecular formula:

C20H38O7S.Na

IUPAC Name:

sodium 1,4-bis[(2-ethylhexyl)oxy]-1,4-dioxobutane-2-sulfonate

Results and discussion

Any other information on results incl. tables

Table 1. Children (3,248) With Any Malformation in Relation to Exposure to Drugs Used for Gastrointestinal Disturbances During Lunar Months 1-4 Among 50,282 Mother-Child Pairs

 

	No. of Mother- Chlld Pairs Exposed	No. of Malformed Children	Crude Relative Risk	Hospital Standardized Relative Risk^1	Survival and Race Standardized Relative Risk^1
Dioctyl sodium sulfosuccinate	30	3	1.55	1.33	1.32

¹Estimated by the Mantel-Haenszel procedure

 

Table 2. Children (2,277) With Malformations Showing Uniform Rates by Hospital in Relation to Exposure to Drugs Used for Gastrointestinal Disturbances During Lunar Months 1-4 Among 50,282 Mother-Child Pairs

	No. of Mother- Chlld Pairs Exposed	No. of Malformed Children	Crude Relative Risk	Hospital Standardized Relative Risk^1	Survival and Race Standardized Relative Risk^1
Dioctyl sodium sulfosuccinate	30	2	1.47	1.34	1.11

 

Table 3. Standardized Relative Risks (SAR) and Their 95% Confidence Intervals (Cl₉₅) for Anytime Malformations Showing Uniform Rates by Hospital in Relation to Drugs Taken for Gastrointestinal Disturbances Used Anytime During Pregnancy (Based on Multiple Logistic Risk Function Analysis)

Drugs taken for GI disturbances	No. of Users	No. of Malformed Children		SRR	Cl95^of RSS
		Observed	Expected
Dioctyl sodium sulfosuccinate	116	3	2.23	1.35	0.28-3.84

 

Applicant's summary and conclusion

Conclusions:

From 30 females who were exposed to Dioctyl sodium sulfosuccinate in months 1-4 of pregnancy, 3 gave birth to malformed children.
From 116 females who were exposed to Dioctyl sodium sulfosuccinate any time during pregnancy, 3 gave birth to malformed children.
There was no evidence to suggest that exposure to drugs taken for gastrointestinal disturbances (440 mother-child pairs) increases the risk of malformations. However, numbers were small and associations between specific drugs and various malformations could not be ruled out.