Registration Dossier

Administrative data

Description of key information

The oral LD0 of distillation residues of butyraldehyde, 2-ethylhexenal and isobutanal hydrogenation by-products, was higher than 2000 mg/kg in rats.

Key value for chemical safety assessment

Acute toxicity: via oral route

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

Additional information

The toxicity of the test item, distillation residues of butyraldehyde, 2-ethylhexenal and isobutanal hydrogenation by-products, was evaluated following a single oral administration in rats according to OECD(No. 423, 17th December 2001) and Commission Regulation (EC) (No. 440/2008, B.1 tris, 30 May 2008) guidelines (Gerbeix, 2010a). The study was conducted in compliance with the principles of Good Laboratory Practice.

The test item, distillation residues of butyraldehyde, 2-ethylhexenal and isobutanal hydrogenation by-products, was administered once by oral route (gavage) to groups of three fasted female Sprague-Dawley rats at dose-levels of300 or 2000 mg/kg under a dosage-volume of 10 mL/kg. The test item was prepared in corn oil.  The study design was as follows:

 

Dose-level

(mg/kg)

Dosage-volume

(mL/kg)

Female

300

10

3

2000

10

3

2000

10

3

 

Each animal was observed at least once a day for mortality and clinical signs for a period of up to 14 days following the single administration. Body weight was recorded on day 1 and then on days 8 and 15. On completion of the observation period, the animals were sacrificed and then submitted for a macroscopic post-mortem examination.No organ samples were taken.

At the 300 mg/kg dose-level (three females), no deaths and no clinical signs were noted. When compared to CIT historical control data the body weight gain of the animals was not affected by treatment with the test item. At necropsy, no apparent abnormalities were observed in any animal.

At the 2000 mg/kg dose-level (three females then confirmation on three other females), no deaths occurred. Hypoactivity or sedation and piloerection (in all animals), staggering gait (in 4 animals) and dyspnea (in 3 animals) were observed on day 1 only. A body weight loss (-3%) was noted between day 8 and day 15 in one female. When compared to CIT historical control data, a lower body weight gain was noted between day 1 and day 8 (vs.41 ±in control data base) in one female and between day 8 and day 15 (vs.15 ±in control data base) in another female. At necropsy, no apparent abnormalities were observed in any animal.

The oral LD0of the test item, distillation residues of butyraldehyde, 2-ethylhexenal and isobutanal hydrogenation by-products, was higher than 2000 mg/kg in rats.

Justification for classification or non-classification

According to the classification criteria laid down in Regulation (EC) N° 1272-2008C and Council Directive 67/548/EEC (and subsequent adaptations), concerning the potential toxicity by oral route, Distillation residues of butyraldehyde, 2-ethylhexenal and isobutanal hydrogenation by-products. should not be classified.