Registration Dossier

Administrative data

Description of key information

Acute toxicity: Oral LD50 (rat, m/f): > 2000 mg/kg bw (OECD 401, GLP)
Acute toxicity: Inhalation LC50 (rat, m/f): > 1.7 mg/L (OECD 403, GLP)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The available information comprises adequate, reliable (Klimisch score 1-2) and consistent studies, and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The available information comprises an adequate and reliable study (Klimisch score 2), and is thus sufficient to fulfil the standard information requirements set out in Annex VIII, 8.5, of Regulation (EC) No 1907/2006.

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute oral toxicity:

An acute oral toxicity study (limit test) with Triacetin (CAS 102-76-1) was performed according to OECD Guideline 401 and GLP (Reijnders, 1988). The test substance was administered by oral gavage at a concentration of 2000 mg/kg bw to groups of five male and female young adult Wistar rats. The animals were observed for 14 days following administration. No mortalities occurred during the study period. No clinical signs of toxicity and no changes in body weight were reported. Necropsy at the end of the 14-day study period did not reveal any substance related findings. The acute oral LD50 was found to be greater than 2000 mg/kg bw for the substance.

In another study (Lawrence, 1974), graded dose levels of Triacetin (0.5, 1, 2, 4, 8, and 16 mL/kg bw equivalent to 580.5, 1161, 2322, 4644, 9288 and 18576 mg/kg bw) were administered by oral gavage to groups of two mice, and the acute LD50 was calculated by Cornfield and Mantel’s modification of Karber’s method, or by the method of Weil, based upon mortalities within a 7-day observation period. The acute oral LD50 for mice was reported to be 8 mL/kg bw, corresponding to 9250 mg/kg bw of the substance.

Acute inhalation toxicity:

An acute nose/head only inhalation toxicity study was performed with Triacetin (CAS 102-76-1) similarly to OECD Guideline 403 and under GLP conditions (Pauluhn, 1985). Five male and five female Wistar rats were exposed for 4 hours to the maximum attainable Triacetin aerosol concentration of 1.7 mg/L (analytical concentration). The nominal concentration used in this study was 20 mg/L. Samples taken from the breathing zone were used to measure the actual Triacetin concentration. 100 % of the aerosol particles were found to be smaller than 5 µm and the MMAD was 1.69 µm. All treated animals survived and no signs of systemic toxicity were observed throughout the 14-day observation period. No local irritation of the visible mucous membranes of the respiratory tract was seen at gross pathology analysis. The acute inhalation LC50 in rats was found to be greater than the maximum attainable aerosol concentration of 1.7 mg/L Triacetin. This concentration is above the maximum saturated vapour concentration of Triacetin, which is 0.5986 mg/L at 20°C.

Acute dermal toxicity:

The acute dermal toxicity of Triacetin (CAS 102 -76 -1) was tested in groups of five albino rabbits administered a single dose of 5000 mg/kg bw of the substance to the intact and abraded skin (Fiume, 2003). According to the authors, none of the rabbits died during the observation period of 7 days after administration. However, as the original study report was not available, but only referenced as short information in a review article, this study was not taken into further account for hazard assessment. 


Justification for selection of acute toxicity – oral endpoint
The selected study is the most adequate and reliable study based on overall quality assessment (refer to the endpoint discussion for further details).

Justification for selection of acute toxicity – inhalation endpoint
There is only one study available.

Justification for selection of acute toxicity – dermal endpoint
Waiver

Justification for classification or non-classification

The available data on acute oral and inhalation toxicity of the substance do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.