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Administrative data

Description of key information

Key studies were available for acute oral (up-and-down-procedure) and acute dermal toxicity (limit test), demonstrating LD50 values of 1098 and >2000 mg/kg bw, respectively. Acute inhalation toxicity testing was waived based on low vapour pressure. 

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
1 098 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

A key study for acute oral toxicity was performed in female Wistar rats according to OECD guideline No. 425 (IIBAT, 2012a). Dosing mixed in corn oil, was performed as a single oral gavage dose to one female animal at dose level of 175 mg/kg b.w. and three female animals (one at a time) at a dose level of 550 mg/kg b.w. These animals did not exhibit clinical signs of toxicity and mortality, hence another three animals (one at a time according to up and down method) were administered 2000 mg/kg b.w. These animals exhibited dullness, piloerection and discharge of blood from anus and died on day 2. Since the stopping criteria were met, dosing was stopped as recommended by the guideline. Following dosing, the surviving rats were observed for 14 days for mortality and clinical signs of toxicity. Body weights of all survived animals were normal and gross pathology of animals dit not reveal any macroscopic lesions. On the basis of the above results, the estimated acute oral LD50 of Proviplast 0142, bis(2 -butoxyethyl)adipate, determined was 1098 mg/kg b.w. Approximate 95% confidence interval is 550 to 2000 mg/kg b.w.

A key acute dermal toxicity study was performed at limit dose of 2000 mg/kg bw applied to the clipped area of 5 male and 5 female rats (IIBAT, 2012b). Following application, the rats were observed for 14 days for morbidity, mortality and clinical sings of toxicity. Animals treated with the test substance did not exhibit any clinical signs of toxicity for the entire observation period. No adverse skin reactions at the site of application were observed following the removal of the test substance. No mortality and morbidity was recorded in rats throughout the observation period. Rats treated with the test substance showed normal body weight during the study. None of the animals showed any macroscopic lesions. From the experimental results, dermal LD50 of Proviplast 0142, bis(2 -butoxyethyl)adipate, for Wistar rat was determined as > 2000 mg/kg b.w.

Finally an LD50 of 600 mg/kg bw was reported after intraperitoneal administration in rats, however no further information could be retrieved (Sigma-Aldrich, ChemID, RTECS).  This information was disregarded as it was based on a secondary source and it does not apply to operating conditions of use. Inhalation testing was waived based on low vapour pressure of the substance and/or the possibiliy of exposure to aerosols, particles or droplets of an inhalable size.

Justification for classification or non-classification

Bis(2-butoxyethyl)adipate (Proviplast 0142/DBEA) was classified as HARMFUL and the symbol 'Xn' and risk phrase R 22 'HARMFUL IF SWALLOWED' are required according the EU labelling reulations Commision directive 93/21/EEC. According to CLP regulation (No. 1272/2008 of 16 December 2008), Category 4 classification is proposed for acute oral toxicity with signal word 'Warning' and hazard sentence H302 'Harmful if swallowed'. Based on these results and according to the EC Directive (No.93/21/EEC) and CLP (No. 1272/2008 of 16 December 2008), Bis(2-butoxyethyl)adipate (Proviplast 0142/DBEA does not have to be classified and has no obligatory labelling requirement for dermal toxicity.