Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Multicomponent substance DETAILS ON MAIN COMPONENTS:

Acute oral toxicity:

MEG: LD50=7712mg/kg


sodium acetate (mouse) LD50=6891mg/kg

Clearly based on the above data, the acute oral toxicity is low. A worse case assumption for the LD50 of ~7000mg/kg is used.

Acute inhalation toxicity:

not toxic to vapours of MEG or DEG, sodium acetate is a solid and exposure to dust is not relevant in the form here.

Acute dermal toxicity:



It is not possible to calculate an average from this data but it would seem appropriate to assume 100% dermal absorption and equate the dermal LD50=oral LD50.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
7 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

There is no acute toxicity data available on the multiconstituent substance, but data is available on the main components from which it can be established that the substance has very low acute toxicity. Data on individual components:

Acute oral toxicity:

Monoethylene glycol (ethan-1,2-diol): BASF (1968) reported an acute oral LD50 value of 7712 mg/kg for male and female rats. Animals were given doses of about 3200, 6400, 8000 and 10000 ul/kg. Clinical signs seen were depression and narcosis. No mortalities were seen in the low dose group, 5 of 20 rats died in th 6400 ul/kg dose group, 16 of 20 rats died in the 8000 ul/kg dose group and 19 of 20 rats died in the 10000 ul/kg dose group.

Diethylene glycol (2,2’-oxydiethanol): Lenk et al. (1989) found an oral LD50 value of 19600 mg/kg for male rats. Narcotic phase, diuretic phase and thirst, drop of the pH of the urine and blood, either recovery or hydrotropic degeneration of the renal tubules and anuria, accumulation of urea and uric acid in the blood and finally death after 2 - 7 days from non-compensated metabolic acidosis and uremia were found in this study.

Sodium acetate: L D50s of 4500 and 6800mg/kg have been reported in rats and mice respectively.

The figure cited for the overall acute oral toxicity is the inverse weighted average of the reciprocals of the oral LD50s for rats based on a worse case composition (maximum sodium acetate cmposition.)

Acute inhalation toxicity:

Monoethylene glycol (ethan-1,2-diol):  BASF (1961) reported an inhalation hazard test result. Rats inhaled a saturated atmosphere at 20°C for 8 hours. No symptoms and no mortalities were observed.

Diethylene glycol (2,2’-oxydiethanol): Cascieri et al. (1991) reported an inhalative LC50 value of > 4.6 mg/l for 4 hours. Rats were given diethylene glycol as an aerosol with maximum attainable concentrations of 4.4 - 4.6 mg/l. There were no deaths during the 14-day observation period. Rapid recovery on removal, a transient body weight loss with recovery within 3 - 5 days and nasal discharge or lacrimation suggestive of minor irritation which persisted for several days were seen in this study. Post-mortem examinations were unremarkable.

Sodium acetate: There is no available data on sodium acetate, but as a solid in solution, inhalation hazards are not expected to occur.


Acute dermal toxicity:

Monoethylene glycol (ethan-1,2-diol): Tyl (1988) reported a developmental toxicity study using mice. Male and female animals were given doses of about 404 mg/kg, 1677 mg/kg and 3549 mg/kg under occlusive conditions. From this study, an acute dermal LD50 value of > 3500 mg/kg for male and female mice was derived.

Diethylene glycol (2,2’-oxydiethanol): A secondary source reported a dermal LD50 value of 13330 mg/kg for rabbits. This test was done under occlusive conditions. No further information about this study is available.

Sodium acetate: There is no available data on sodium acetate. As an inorganic substance, dermal absorption would be expected to be negligible.

Justification for classification or non-classification

According to the weight of information available, classification for acute toxicity is not warranted according to the animal data. However, since humans appear to be more sensitive to toxicity than animals (see chapter 7.10.1), maintenance of classification as harmful by the oral route ( cat 4 )according to regulation 1272/2008 appears to be warranted based on the level of ethylene and diethylene glycol present. Clasification by any other route is not warranted.