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Administrative data

Description of key information

NOAEL for subacute toxicity: 735 mg/kg bw/d
NOAEL for subchronic toxicity: 300 mg/kg bw/d

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
300 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Additional information

Triethyleneglycoldivinylether was administered to rats by intragastric intubation, daily, for twenty-eight consecutive days at dosage levels of 60, 210 and 735 mg/kg bw/day (GAF chemicals, GFC 7/8874). No clinical abnormalities were observed for any rat during the four-week treatment period. In comparison with control animals, statistically significant higher blood cholesterol levels were recorded in the high dose group during week 4 for female rats. No other statistically significant changes in biochemical parameters were recorded. Since there was also no associated liver toxicity, this effect is not considered as adverse. In all other respects, including general health, bodyweight gains, food consumption, haematology, organ weights, macroscopic and microscopic pathology, rats receiving the test substance were similar to those receiving the vehicle. The NOAEL for male and female rats was 735 mg/kg bw/day (highest dose tested).

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/d for up to 20 weeks (OECD 416; BASF 73R0162/03041). There were no indications for reproductive or developmental toxicity. The clinical 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 bw/d). 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, all male and nearly all female F0 and F1 parental animals of the high dose group (1,000 mg/kg bw/d) showed transient salivation during major parts of the treatment period. Salivation persisted in the respective animals only for some minutes after daily gavage dosing. There occurred no mortalities that could be causally related to the test substance. Food consumption and body weight data of the F0 and F1 parents, collected during premating, gestation, and/or lactation phases, were not influenced by the test substance administration. Regarding pathology, kidneys and liver proved to be the target organs in both genders of the two parental generations at the top dose (1,000 mg/kg body weight/day). The absolute and relative kidney weights were statistically significant increased in high dose F0 and F1 males and showed corroborative histopathological findings (i.e. increased incidence of chronic progressive nephropathy). The mean liver weights were statistically significantly increased in high dose F0 males (relative) and in the top dose F1 males and F1 females (absolute and relative). The increased liver weights correlated with a minimal centrolobular hypertrophy of hepatocytes that was noted in seven high dose F1 males (controls: one F1 male). Although there was no histopathological correlate for the F0 males and F1 females at 1,000 mg/kg, the increased liver weights of these rats are also considered as substance related. Thus, the NOAEL for overall general toxicity on the parental rats could be fixed at 300 mg/kg body weight/day.

No data are available on the dermal or inhalation route.

Justification for classification or non-classification

The criteria for classification according to EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 are not met.