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Administrative data

Description of key information

Several acute toxicity studies are available for oral, dermal and inhalation toxicity.  The studies were conducted on rats, mice and rabbits.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
464 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
LC50
Value:
1.75 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
1 980 mg/kg bw

Additional information

Acute Oral Toxicity:

In a study conducted in 1979, the test substance, Glycid, was investigated for its ability to cause toxicity when administered via the oral route to male and female Sprague-Dawley rats. The test substance was administered via oral gavage at concentrations of 0.147, 0.215, 0.316, 0.681 and 1.0ml/kg, with only females receiving the highest dose level. The test animals were observed for 14 days up to 4 weeks.

Mortalities were observed in each test group, except the 2 lowest concentrations. In the 0.316 ml/kg dose group 2 females died after 24 hours and 2 females and 1 male died after 14 days. In the 0.464 ml/kg dose group 5 males and 7 females died after 24 hours and 5 males and 7 females died after 14 days. In the 0.681 ml/kg dose group, 10 males and 8 females died after 24 hours and 10 males and 9 females died after 14 days. In the 1.0 ml/kg dose group, all female test animals died. Other observations included sedation, ataxia and a prone position, as well as reduced food consumption. Macropscopic findings included ulceration of the stomach wall and effects on the liver and kidneys.

Under the conditions of this study, an acute oral toxicity LD50 value of 464 mg/kg bw was determined. Based on this result, the test substance should be considered to be a category 4 toxicant, with the hazard statement H302: Harmful if swallowed and the signal word Warning associated with it, according to Regulation EC No. 1272/2008. According to Directive 67/548/EEC, the test substance should be classified as Harmful (Xn) and have the risk phrase R22: Harmful if swallowed associated with it.

The results of the supporting studies support the classification appled to the key study.

Acute Dermal Toxicity:

In a study conducted by Hine et al (1956), the test substance Glycidol was tested for its ability to induce toxicity when applied cutaneously to the backs of male rabbits in a single application for an exposure of 7 hours. The test substance was applied undiluted to the freshly clipped backs of rabbits. The rabbits were then placed in a rubber sleeve, wrapped in towelling and held in multiple rabbit holder for the 7 hour exposure period.

When death occured it was usually within 17 hours, although occasionally delayed as long as 5 days. Minimal clinical signs were observed following exposure.

Under the conditions of this experiment, the LD50of the test substance was determined to be 1980mg/kg bw. Based on this result, the test substance should be classified as a Category IV toxicant according to Regulation EC No. 1272/2008 and should have the signal word "Warning" and the hazard statement H312: Harmful if swallowed associated with it. According to Directive 67/548/EEC, the test substance should be classified as Harmful (Xn) and have the risk phrase R21: Harmful in contact with the skin associated with it.

Acute Inhalation Toxicity:

In a study conducted by Hine et al in 1956, the test substance, Glycidol, was tested for its ability to acute cause toxicity when administered to male Long Evan rats via whole-body inhalation. The test animals were exposed to the test substance for a period of 8 hours and the animals were observed for effects for 10 days post-treatment. Following this observation period, signs of intoxication included dyspnea, lacrimation, salivation, nasal discharge, aerophagia, terminal CNS depression but also signs of stimulation, with death usually caused by pulmonary oedema. The most common pathological finding was irritation of the lungs, and pneumonitis was confirmed by microscopic examination and an inexplicable case of pulmonary emphysema was also recorded. Based on the results of this study, the LD50was determined to be 580ppm, this is equivalent to 1.75 mg/L. Under the conditions of this study, the test substance should be classified as a Category II toxicant according to Regulation EC No. 1272/2008 and should have the signal word Danger and the hazard statement H330: Fatal if inhaled associated with it. According to Directive 67/548/EEC, the test substance should be classified as a

The results of the supporting study correspond to the results of the key study.

Justification for classification or non-classification

Acute Oral Toxicity:

Based on the results of the key study, the test substance should be considered to be a Category 4 toxicant, with the hazard statement H302: Harmful if swallowed and the signal word Warning associated with it, according to Regulation EC No. 1272/2008. According to Directive 67/548/EEC, the test substance should be classified as Harmful (Xn) and have the risk phrase R22: Harmful if swallowed associated with it.

Acute Dermal Toxicity:

Based on the results of the key study, the test substance should be classified as a Category IV toxicant according to Regulation EC No. 1272/2008 and should have the signal word "Warning" and the hazard statement H312: Harmful if swallowed associated with it. According to Directive 67/548/EEC, the test substance should be classified as Harmful (Xn) and have the risk phrase R21: Harmful in contact with the skin associated with it.

Acute Inhalation:

Under the conditions of the key study, the test substance should be classified as a Category II toxicant according to Regulation EC No. 1272/2008 and should have the signal word Danger and the hazard statement H330: Fatal if inhaled associated with it. According to Directive 67/548/EEC, the test substance should be classified as

R23, Toxic by inhalation

Since the harmonised classification for 2,3 -epoxypropanol indicates classification as STOT SE 3 H335 May cause respiratory irritation, based on the results of the acute inhalation study, it is indicated that the commonest pathological finding was irritation of the lungs and pneumonitis was confirmed by microscopic examination (and an inexplicable case of pulmonary emphysema was also recorded). These findings result in the STOT classification and are considered significant. Acute Tox Cat 2 and H330 Fatal if inhaled are included with the STOT SE3 classification.