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Effects on fertility

Effect on fertility: via oral route
Dose descriptor:
NOAEL
450 mg/kg bw/day
Additional information

Two-generation study according to TSCA Health Effects Test Guideline for specific organ/tissue toxicity - Reproduction/Fertility effects (EPA, 1983): Sprague-Dawley rats were given daily 0, 30, 175, or 450 mg/kg bw/day m-cresol in corn oil by gavage.

Effects on reproductive function or on morphology of reproductive tissues were not detected even at doses producing overt toxicity in adult rats (hypoactivity, ataxia, twitches, tremors, prostration,urine stains, audible respiration, and perioral wetness). The NOAEL (fertility) was 450 mg/kg bw/day. The NOAEL (toxicity) was 30 mg/kg bw/d. In F1 and F2 , litter size, sex ratio, and litter viablity was unaffected by treatment. In F1 the female pups had reduced body weights in the highest dose tested, but pup survival was not affected. In F2, pup body weight, pup body weight gain and pup lactational index were reduced and pup mortality was increased at the highest dose. Thus the NOAEL (offspring) was 175 mg/kg bw/d


Short description of key information:
Reproductive toxicity was examined in a two-generation toxicity study according to TSCA Health Effects Test Guideline for specific organ/tissue toxicity - Reproduction/Fertility effects(Union Carbide for CMA 1988). Sprague-Dawley rats were given daily 0, 30, 175, or 450 mg/kg bw/day m-cresol in corn oil by gavage. No effects on fertility were detected despite overt general toxicity Thus, the NOAEL(fertility) was 450 mg/kg bw/day and the NOAEL(general toxicity) was 30 mg/kg bw/day..

Effects on developmental toxicity

Description of key information
In a developmental toxicity study according to TSCA Health Effects Test guidelines for Specific Organ/Tissue Toxicity - Developmental Toxicity (CMA 1988): m-cresol was administered  by gavage to time-pregnant-Sprague Dawley rats during organogenesis at 0.0, 30, 175, 450 mg/kg bw/d and resulted in maternal toxicity at 450 mg/kg bw/day  (NOAEL (maternal toxicity) 175 mg/kg bw/d). m-Cresol did not induce fetotoxicity or malformations at any dose level tested (NOAEL(developmental toxicity) 450 mg/kg bw/day).
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
450 mg/kg bw/day
Additional information

Developmental toxicity study was performed according to TSCA Health Effects Test guidelines for Specific Organ/Tissue Toxicity - Developmental Toxicity (EPA, 1984,1987):

Administration of m-cresol by gavage to time-pregnant-Sprague Dawley rats during organogenesis at 0.0, 30, 175, 450 mg/kg bw/d resulted in maternal toxicity at 450 mg/kg bw/day including significant reduction in periodic maternal body weights and weight gain during the dosing period in addition with clinical signs of toxicity (NOAEL (maternal toxicity) 175 mg/kg bw/d). m-Cresol did not induce fetotoxicity or malformations at any dose level tested.(NOAEL(developmental toxicity) 450 mg/kg bw).

In addition. in a further developmental toxicity study according to TSCA Health Effects Test guidelines for Specific Organ/Tissue Toxicity - Developmental Toxicity (EPA, 1984,1987): m-cresol was administered by gavage to time-pregnant New Zealnd White rabbits during organogenesis at 0.0, 5.0, 50.0, 100.0 mg/kg bw/d resulting in clinical signs of toxicity including audible respiration and ocular discharge from 50 mg/kg bw/d onwards (NOAEL (maternal toxicity) 5.0 mg/kg bw/d). No developmental effects were seen at any dosage employed (NOAEL(developmental toxicity) 100 mg/kg bw/d).

Toxicity to reproduction: other studies

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