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Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information
Teratogenic effects (osteolathyrism): EC50= 12.72 g/L, 96 h embryos/tadpoles of the African clawed frog, FETAX (ASTM E1439-98), Schultz 1998, not reliable test system
Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Toxicity to reproduction: other studies

Additional information

Schultz et al (1988) investigated the test item Sym-diacetyl hydrazine (CAS 3148-73-0), which represents the submission item, for lethal and morphological effects (teratogenicity, malformations) to embryos of the African clawed frog (Xenopus laevis). The non-GLP study was conducted according to the Frog Embryo Teratogenesis Assay-Xenopus (FETAX) protocol according to ASTM E1439-98. However the experiments are considered reliable with restrictions in regard to the determination of a 50% effect level of lethal and sublethal effects to aquatic amphibian development stages (see section on “Toxicity to other aquatic organisms”), the protocol has been evaluated an unsuitable test system for the assessment on toxicity to reproduction (NICATM 2000). Accordingly it is not regarded as reliable in the context of this endpoint. The authors found a Teratogenic Index (TI) calculated as molar LC50/EC50 of 1.5, which is by a factor of 762 lower than the one of the positive control substance for osteolathyrism (Semicarbazide hydrochloride (CAS 563-41-7). Nonetheless the submission item was able induce this connective tissue defect (Mekenyan et al 1996), which may indicate an affiliation to a respective category/mode of action, this is considered not relevant as the effect level was close to the LC50 as expressed by the TI and in addition the effect levels were as high as 96 h LC50 = 18.96 g/L and the 96 h EC50 = 12.72 g. In conclusion this study does not evidence a relevant teratogenic risk of the submission item.

  • NICEATM (NTP Interagency Center for the Evaluation of Alternative Toxicological Methods) (2000). Background Review Document (BRD) Frog Embryo Teratogenesis Assay - Xenopus (FETAX). Prepared by The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM). Edited by National Institute of Environmental Health Sciences (NIEHS), Research Triangle Park, NC 27709, U.S.A. 273 p

Justification for classification or non-classification

Additional information