Category

Description

Controlled human
studies show no
risk.

No evidence of risk
in humans

Risk cannot be
ruled out.

Positive evidence
of risk.

Contraindicated in
pregnancy.

Interpretation

Adequate, well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus
trimester of pregnancy.

Adequate, well-controlled studies in pregnant women have not shown increased risk of fetal abnorm
despite adverse findings in animals, or, in the absence of adequate human studies, animal studies
fetal risk. The chance of fetal heart is remote, but remains a possibility.

Adequate, well-controlled human studies are lacking, and animal studies have shown a risk to the f
are lacking is well. There is a chance of fetal harm if the drug is administered during pregnancy; bu
potential benefits may outweigh the potential risk.

Studies in humans, or investigational or post-marketing data, have demonstrated fetal risk. Nevert
potential benefits from the use of the drug may outweigh the potential risk. For example, the drug
acceptable if needed in a life-threatening situation or serious disease for which safer drugs cannot
or are ineffective.

Studies in animals or humans, or investigational or post-marketing reports, have demonstrated pos

evidence of fetal abnormalities or risk which clearly outweighs any possible benefit to the patient.

Drug and Pharmaceutical Reproductive an

No.

Drug/Substance

CAS Number

Location

Diethyldithiocarbamate

148-18-5

Laboratorium

Ethanol

64-17-5

Laboratorium/
Warhouse

Ibuprofen

15687-27-1

Iodine

7553-56-2

Laboratorium

Methylene blue

61-73-4

Laboratorium

Potassium iodide

7681-11-0

Laboratorium

Valproate sodium

1069-66-5

Laboratorium/
Warhouse

Valproic acid

99-66-1

Laboratorium/
Warehouse

Laboratorium/
Warhouse

al Reproductive and Developmental Toxicants List

Comments/Notes
Controversy exists as to categoryCategory X
Category C (noted reports of malformations but unknown relationship to disulfiram; noted
embryotoxicity)
Category D
Category X (when used in large amounts or for prolonged periods) (developmental defects,
which may include the fetal alcohol syndrome low birth weight, spontaneous abortion, growth
retardation, congenital anomalies placental toxicity )500
Breastfeeding: Compatible
contraindicated
Category B
Category D at end of pregnancy (may cause premature closure of ductus
arteriosus and delay parturition) Breastfeeding: Compatible
Category D
Breastfeeding: Not compatible (concentrated in breast milk, and long
term use may adversely affect the nursing infant's thyroid activity)
Category C
Category D if injected intra-amniotically (hemolytic anemia, jaundice, intestinal atresia with
intraamniotic injection
Category D (can cause fetal harm) Breastfeeding: Compatible
(excreted in breast milk, may cause skin rash and thyroid suppression in the infant)
Category D (can produce teratogenic effects), decreased cognitive
functioning at age 3 years
Breastfeeding: Consider discontinuingnursing (excreted in breast milk)
Category D (may produce teratogenic effects)
Breastfeeding: With caution (excreted in breast milk)

Chemical Reproductive and De

No.

Agent

CAS Number

Location

Arsenic

7440-38-2

Laboratorium

Nitrobenzene

71-43-2

Laboratorium

Carbon disulfide

75-15-0

Laboratorium

Iodine

7553-56-2

Laboratorium

Lead (Pb)

7439-92-1

Laboratorium

Methylene blue

61-73-4

Laboratorium

Toluene

108-88-3

Laboratorium

Trichloroethylene

79-01-6

Laboratorium

Reproductive and Developmental Hazards List

Notes
Pregnancy: Occupational exposure to inhaled inorganic arsenic associated with increased incidence of congenital
malformations and decreased birth weight Ingested inorganic arsenic has been reported in association with premature
delivery and subsequent neonatal death Placental toxicity Appears in cord blood in almost same levels as maternal blood
Breastfeeding: Low concentrations in breast milk
Pregnancy: Spontaneous abortion, premature births, neonatal complications
Male: Spermatotoxic decreased libido, impotence
Female: Menstrual irregularities, decreased fertility, increased spontaneous abortion
Pregnancy: 4 ppm (10 mg/m3) recommended as occupational exposure limit during pregnancy birth defects reported
children's intelligence hindered significantly when one or both of their parents were exposed to carbon disulfide at levels
greater than 10 mg/m3 (3 to 4 ppm), in addition to birth defects [Li]
Breastfeeding: Can cross the placental barrier and be secreted into mothers' milk
Category D
Breastfeeding: Not compatible (concentrated in breast milk, and long term use may adversely affect the nursing infant's
thyroid activity)
Male: Lowered number of sperm, abnormal sperm shape, altered sperm transport
Female: Premature membrane rupture and preterm births 8 Developmental
Breastfeeding: Possible neurotoxicity
Category C
Category D if injected intraamniotically (hemolytic anemia, jaundice, intestinal atresia with intra-amniotic injection
Toluene embryopathy has been reported (motor and intellectual effects) (developmental delay, CNS dysfunction,
hydronephrosis, ventricular septal defects, craniofacial and limb anomalies including microcephaly
Male: impotence (occupational exposure)
Female: amenorrhea, irregular menses (after accidental exposure to high levels)