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Effects on fertility

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

A two-generation study has been undertaken on 1,2 -Benzenedicarboxylic acid, di-C6 -10 -alkyl esters. In this study reproductive effects occurred, seen as reduced pup survival and weights, and a marginal delay in sexual maturity at a treatment level of 10000 ppm. Effects on reproductive organs, liver and kidney were essentially similar in all generations and were therefore not classed as specific reproductive effects. The NOAEL for reproductive toxicity was therefore considered to be 3000 ppm (corresponding to a mean daily intake of 167 -776 mg/kg bw/d, mean concentration in males 235 mg/kg bw/d and mean concentration in females 346 mg/kg bw/d). It was not possible to identify a no effect level in this study, although at 1000 ppm (corresponding to an intake in the range of 56 -253 mg/kg bw/d) were confined to increased liver and kidney weights among F1 females (LOAEL 1000 ppm).

A similar study has been undertaken on a structurally related substance,1,2 benzene dicarboxylic acid , di C9-C11 alkyl esters which has C-chain lengths of C9, C11 compared to 1,2-Benzenedicarboxylic acid, di-C8-10-alkyl esters C8 and C10. In this study no adverse effects upon fertility or reproductive performance when rats were exposed to diets containing up to 10000 ppm, corresponding to a mean daily intake of at least 650 mg/kg/day, through two successive generations. D911P fed through two generations had no adverse effect on the seminology parameters investigated and no histopathological effects on the reproductive organs.


Short description of key information:
Fertility: NOAEL - 235 mg/kg/day

Effects on developmental toxicity

Description of key information
Developmental toxicity: NOAEL - 1000 mg/kg/day 
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Additional information

A study of developmental toxicity has been undertaken on 1,2 -Benzenedicarboxylic acid, di-C6 -10 -alkyl esters. In this study slight maternal effects were observed at 1000 mg/kg bw/day indicated by slightly increased body weight gain and food consumption. Foetal effects were confined to increases in the incidence of vestigial supernumerary ribs at 500 and 1000 mg/kg bw/day and to a slight increase in the incidence of retarded sternebrae at 1000 mg/kg bw/day. Both of these findings were considered to be of a minor nature. The No Observed Adverse Effect Level (NOAEL) for maternal toxicity was considered to be 500 mg/kg bw/day. The No Observed Adverse Effect Level (NOAEL) for developmental toxicity was considered to be 1000 mg/kg bw/day.

A similar study of developmental toxicity has been undertaken on a structurally related substance,1,2 benzene dicarboxylic acid , di C9-C11 alkyl esters which has C-chain lengths of C9, C11 compared to 1,2-Benzenedicarboxylic acid, di-C8-10-alkyl esters C8 and C10. In this study no clear adverse effects on pregnancy of the female rat or on embryofoetal survival and development were apparent at dose levels up to 1000 mg/kg bw/day.

Justification for classification or non-classification