Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Additional information

Triethylenglycoldivinylether was orally administered in a 2-generation reproduction toxicity study to groups of 25 male and 25 female Wistar rats at dosages of 0; 100; 300 and 1,000 mg/kg bw/day (OECD 416; BASF 73R0162/03041). There were no indications from the clinical examinations, sperm evaluations and gross and histopathology, that the administration of Triethylenglycoldivinylether adversely affected reproductive performance or fertility of the F0 or F1 parental animals up to and including a dose of 1,000 mg/kg body weight/day. Estrous cycle data, mating behavior, conception, gestation, parturition, lactation and weaning as well as sperm parameters, sexual organ weights and gross and histopathological findings of these organs (including differential ovarian follicle counts in the F1 females) were not affected by the test substance administration. The examinations of the F0 and F1 parental rats for general signs of toxicity revealed some substance-related effects at the high dose (1,000 mg/kg body weight/day). These were substantiated by unsteady gait and/or abdominal position, which occurred intermittently in several, but not all top dose rats shortly after gavage dosing and persisted only for some minutes. Moreover, absolute and relative kidney weights were statistically significantly increased in high dose F0 and F1 males and showed corroborative histopathological findings (i.e. increased incidence of chronic progressive nephropathy). Thus, the NOAEL (no observed adverse effect level) for fertility and reproductive performance is 1,000 mg/kg body weight/day. The NOAEL for overall general toxicity on the parental rats could be fixed at 300 mg/kg body weight/day.


Short description of key information:
OECD 416: NOAEL 1000 mg/kg bw/d

Effects on developmental toxicity

Description of key information
OECD 416: NOAEL 1000 mg/kg bw/d
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Additional information

Triethylenglycoldivinylether was orally administered in a 2-generation reproduction toxicity study to groups of 25 male and 25 female Wistar rats at dosages of 0; 100; 300 and 1,000 mg/kg bw/day (OECD 416; BASF 73R0162/03041). The examinations of the F0 and F1 parental rats for general signs of toxicity revealed some substance-related effects at the high dose (1,000 mg/kg body weight/day). These were substantiated by unsteady gait and/or abdominal position, which occurred intermittently in several, but not all top dose rats shortly after gavage dosing and persisted only for some minutes. Moreover, absolute and relative kidney weights were statistically significantly increased in high dose F0 and F1 males and showed corroborative histopathological findings (i.e. increased incidence of chronic progressive nephropathy). No test substance induced signs of developmental toxicity occurred in the progeny of the F0 or F1 parents up to and including 1,000 mg/kg body weight/day. The test substance did not influence the number of delivered F1 and F2 pups/litter, the sex ratio, the postnatal survival, the pup body weights or the sexual maturation of the F1 progeny. Clinical and/or gross necropsy examinations of the F1 and F2 pups revealed only findings that were considered to be spontaneous in nature, due to their scattered occurrence without any relation to dose. Thus, the NOAEL for pre- and postnatal developmental toxicity (growth and development of the offspring) is 1,000 mg/kg body weight/day. The NOAEL for overall general toxicity on the parental rats could be fixed at 300 mg/kg body weight/day.

Justification for classification or non-classification

Based on the well-conducted 2 -generation reproduction toxicity study, classification for reproductive toxicity is not warranted according to EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.