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Administrative data

Key value for chemical safety assessment

Toxicity to reproduction: other studies

Description of key information

Reproductive effects on Rat

TDLo - ROUTE: intraperitoneal; DOSE: 400 mg/kg DURATION: female 1-7D of pregnancy; [Fertility and Sterility. (American Fertility Soc., 608 13th Ave. S, Birmingham, AL 35282) V.1- 1950- (21,431,1970)]

TOXIC EFFECTS:

Effects on Fertility - Post-implantation mortality (e.g., dead and or resorbed implants per total number of implants)

Effects on Fertility - Litter size (e.g., # fetuses per litter, measured before birth)

TDLo - ROUTE: oral; DOSE: 300 mg/kg DURATION: female 9-14D of pregnancy; [Oyo Yakuri. Pharmacometrics. (Oyo Yakuri Kenkyukai, CPO Box 180, Sendai 980-91, Japan) V.1- 1967- (7,41,1973)]

TOXIC EFFECTS:

Effects on Fertility - Post-implantation mortality (e.g., dead and or resorbed implants per total number of implants)

Effects on Embryo or Fetus - Fetotoxicity (except death, e.g., stunted fetus)

Effects on Embryo or Fetus - Fetal death

TDLo - ROUTE: oral; DOSE: 150 mg/kg DURATION: female 9-14D of pregnancy;

[Oyo Yakuri. Pharmacometrics. (Oyo Yakuri Kenkyukai, CPO Box 180, Sendai 980-91, Japan) V.1- 1967- (7,41,1973)]

TOXIC EFFECTS:

Specific Developmental Abnormalities - Musculoskeletal system

TDLo - ROUTE: subcutaneous; DOSE: 400 mg/kg DURATION: female 10-11D of pregnancy; [Teratology, The International Journal of Abnormal Development. (Alan R. Liss, Inc., 41 E. 11th St., New York, NY 10003) V.1- 1968- (18,93,1978)]

TOXIC EFFECTS:

Effects on Embryo or Fetus - Other effects to embryo

TDLo - ROUTE: unreported; DOSE: 250 mg/kg DURATION: female 10-11D of pregnancy; [Naunyn-Schmiedeberg's Archives of Pharmacology. (Springer Verlag, Heidelberger, Pl. 3, D-1000 Berlin 33, Fed. Rep. Ger.) V.272- 1972- (293(Suppl),R60,1976)]

TOXIC EFFECTS:

Effects on Embryo or Fetus - Fetal death

Reproductive effects on Mouse

TDLo - ROUTE: oral; DOSE: 2400 mg/kg DURATION: female 7-12D of pregnancy; [Oyo Yakuri. Pharmacometrics. (Oyo Yakuri Kenkyukai, CPO Box 180, Sendai 980-91, Japan) V.1- 1967- (7,41,1973)]

TOXIC EFFECTS:

Effects on Embryo or Fetus - Fetotoxicity (except death, e.g., stunted fetus)

Specific Developmental Abnormalities - Musculoskeletal system

TDLo - ROUTE: oral; DOSE: 6 gm/kg DURATION: female 7-12D of pregnancy; [Oyo Yakuri. Pharmacometrics. (Oyo Yakuri Kenkyukai, CPO Box 180, Sendai 980-91, Japan) V.1- 1967- (7,41,1973)]

TOXIC EFFECTS:

Effects on Fertility - Post-implantation mortality (e.g., dead and or resorbed implants per total number of implants)

Effects on Embryo or Fetus - Fetal death

Source: RTECS Number AB6680000

No epidemiological studies of congenital anomalies in children born to women who took thiamphenicol during pregnancy have been reported.

In one series of studies, the frequency of congenital anomalies was no greater than expected among the offspring of mice or rats treated during pregnancy with thiamphenicol in doses, respectively, 1-33 and 1-3 times those used clinically (Suzuki et al., 1973a, b). Fetal loss occurred at the higher doses which were toxic to the mothers. In contrast, an increased frequency of skeletal malformations was reported among the offspring of rats treated with 2 times the usual human dose of thiamphenicol very early in pregnancy in another study (Silva & Andrade, 1970).

Key References:

Silva NOG, Andrade ATL: The effects of thiophenicol upon the rat conceptus. Fertil Steril 21(5):431-433, 1970. [A]

Suzuki Y, Kondo S, Okada F, Suzuki I, Asano F, Matsuo M, Chiba T: [Effects of thiamphenicol administered to the pregnant animals upon the development of their fetuses and neonates.]

Oyo Yakuri (Pharmacometrics) 7(1):41-51, 1973a. [A]

Suzuki Y, Okada F, Kondo S, Suzuki I, Asano F, Matuo M, Chiba T: [Effects of thiamphenicol glycinate hydrochloride administered to the pregnant animals upon the development of their

fetuses and neonates.] Oyo Yakuri (Pharmacometrics) 7(5):859-870, 1973b. [A]

Justification for classification or non-classification