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Diss Factsheets

Administrative data

Description of key information

The acute oral toxicity is very low and the key LD50 value in rats was 4595 mg/kg bw. The acute inhalation toxicity in rats is also very low. The ALC in rats was greater than 6.2 mg/L/4h.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
4 595 mg/kg bw

Additional information

Acute oral toxicity

Butyl glycollate (97%) was tested for its acute oral toxicity in groups of fasted female Wistar rats (10/group) The rats received a single oral dose as 25% solution in sesame oil at dose levels of 2500, 4000, 5000, 6300, 10000 mg/kg bw and were observed for 7 days. The LD50 was determined according to the method of Kaerber.

Beside apathy prior to deaths there were no treatment related clinical signs and no findings at necropsy. Deaths occurred within 1 – 24 hours and were restricted to the dose levels of 4000 mg/kg bw and above. None of the animals died at 2500 mg/kg bw, a dose level above the current requirement for a limit dose. LD50-value was 4595 mg/kg bw (Scholz and Weigand, 1968a).

Two additional studies resulted in comparable acute toxicity values of LD50: 4240 mg/kg bw (Scholz and Weigand, 1967) and of LD50: 4825 mg/kg bw (Scholz and Weigand, 1968b).

Acute inhalation toxicity

The approximate lethal concentration (ALC) was determined in four groups of 6 male Crl:CD®(SD)IGS BR rats, each exposed nose-only for a single, 4-hour period to vapor or aerosol/vapor concentrations of butyl glycollate (99.07%) in air to chamber concentrations of 0.40, 3.0, 4.3, or 6.2 mg/L. Rats were weighed and observed for clinical signs of toxicity during a 14-day recovery period. All surviving rats were sacrificed and discarded without pathological examination at the end of the recovery period. Four groups of 5 male satellite rats each were exposed along with the groups designated for ALC determination. All satellite animals were sacrificed approximately 24 hours after exposure, followed by complete gross examination, and representative samples of the nose, pharynx/larynx, and lungs were examined microscopically. The mass median aerodynamic diameters for the aerosol tested ranged from 2.8 to 3.1µm with 3.8 to 5.5% of the particles less than 1 µM, 49 to 54% of the particles less than 3 µM, and 96 to 98% of the particles less than 10 µM.

No rat died following exposure and no clinical signs of toxicity attributable to the test item were observed during the study. All rats exposed at 3.0 mg/L and above and 4 of 6 rats exposed at 0.40 mg/L experienced slight to severe body weight losses the day after exposure but all rats subsequently resumed normal weight gains and gained weight for the remainder of the recovery period.

There were no gross abnormalities. Compound-related microscopic findings consisted of irritation in the nose of rats exposed at concentrations of =3.0 mg/L. There were no compound-related microscopic findings in the pharynx/larynx and lungs.

The approximate lethal concentration (ALC) for butyl glycollate in male rats was >6.2 mg/L/4h. The no observed- effect level for upper respiratory irritation in male rats was 0.40 mg/L, the lowest observed effect level (LOEL) was 3.0 mg/L (Bamberger JR, 2000).

In conclusion, three valid and appropriate studies on the acute oral toxicity of butyl glycollate in rats are available. The acute oral toxicity is very low and the LD50values ranged between 4240 mg/kg bw - 4595 mg/kg bw. No specific signs of intoxication were noted.

The acute inhalation toxicity in rats is also very low. The approximate lethal concentration (ALC) for butyl glycollate in male rats was >6.2 mg/L/4h, the highest concentration tested. Specific signs of systemic toxicity were not noted. but histopathology in satellite animals revealed slight signs of upper respiratory irritation in the nose only at 3.0 mg/L. No sign of respiratory irritation was observed in pharynx, larynx or lung.

Justification for classification or non-classification

Classification for acute oral toxicity and inhalation 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 based on the selected key studies (rat oral LD50 = 4595 mg/m³ and rat inhalation LC50 >6.2 mg/L/4h).