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Administrative data

Description of key information

Several studies are available, covering oral, dermal and inhalation repeated dose toxicity.  The studies were conducted using male and female Fischer 344 rats, male Californian rabbits and male Long-Evans rats.  

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
LOAEL
25 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Dose descriptor:
LOAEL
200
Study duration:
subacute
Species:
rabbit

Additional information

Repeated Dose Toxicity: Oral

In the study conducted in 1990, the test substance Glycidol was examined for its ability to cause toxicity when administered by oral gavage to male and female Fischer 344 rats for 13 weeks. The test substance was administered 5 days a week for 13 weeks at doselevels of 25, 50, 100, 200 or 400 mg/kg. Ten animals per sex per dose were administered. All rats receiving 400 mg/kg bw died by week 2. Three out of 10 males and 1 out of 10 females that received 200 mg/kg also died before the end of the study. Reduced sperm motility and a reduction in the number of sperm in semen from the cauda epididymis was observed in the 25 mg/kg dose group. Reduced mean body weights were observed in the 50 mg/kg dose group and testicular atrophy/degeneration was observed in the 200 mg/kg dose group. Based on these results, the test substance should be classified as STOT-RE category 2 with the signal word "Warning" and the hazard statement H373: May cause damage to organs (testicles, brain, kidneys, thymus) through prolonged or repeated exposure via the oral route, in accordance with Regulation EC No. 1272/2008.

Repeated Dose Toxicity: Dermal

In a study conducted by Hine et al, (1956), the test substance, Glycidol, was examined for its ability to cause toxicity when applied to the shaved intact backs of 6 male Californian albino rabbits for 1 hour per day for successive days until eschar formation made it impossible for additional applications or systemic toxicity was observed. The test substance was applied at a dose of 200 µl glycidol to an area approximately 1cm2in diameter. Following treatment, 3 of the 6 animals died after the 7th application of the test substance. Signs of systemic toxicity were recorded 48 hours prior to death and the surviving animals did not have a normal appearance. The erythema observed was greater than the oedema and appeared earlier, with a steady progression in the degree of irritation observed with each successive application. Maximum irritation appeared on the 4th day of application in some animals. Necropsy reported a relatively localized effect with deep penetration. Since the study design included only a single dose level and that dose resulted in treatment-related mortality, the 200 µL/cm2/day dose was the lowest observed adverse effect level. An NOAEL was not identified in this study.

Based on the results of this study, the test substance should be classified as a STOT-RE2 toxicant with the Signal word "Warning" and the Hazard Statement H373: May cause damage to organs through prolonged or repeated exposure via the dermal exposure.

Repeated Dose Toxicity: Inhalation

In a study conducted in 1956 by Hines et al,the test substance was examined for its ability to cause toxicity when administered to male Long-Evans for a testing period of 50 days. The test animals were exposed to the test substance 7 hours per day, 5 days per week for 50 days via the inhalation route. The test substance was admininstered at a concentration of 400 ppm. The test animals were observed during exposure and gross and histopathological examinations were conducted following exposure. Following exposure, no mortality, no effect on organ weights and no gross histopathological lesions occured. A slight decrease of peritoneal fat, slightly increased haemoglobin concentration and slight retardation of weight gain were observed.


Repeated dose toxicity: via oral route - systemic effects (target organ) cardiovascular / hematological: other

Repeated dose toxicity: dermal - systemic effects (target organ) other: skin

Justification for classification or non-classification

Repeated Dose Toxicity: Oral

The test substance should be classified as STOT-RE category 2 with the signal word "Warning" and the hazard statement H373: May cause damage to organs (testicles, brain, kidneys, thymus) through prolonged or repeated exposure via the oral route, in accordance with Regulation EC No. 1272/2008.

According to Directive 67/548/EEC, the test substance should be classified as R48/22 Risk of serious damage to health by prolonged exposure.

Repeated Dose Toxicity: Dermal

The test substance should be classified as a STOT-RE2 toxicant with the Signal word "Warning" and the Hazard Statement H373: May cause damage to organs through prolonged or repeated exposure via the dermal exposure. According to Directive 67/548/EEC, the test substance should be classified as R48/21 Risk of serious damage to health by prolonged exposure.

Repeated Dose Toxicity: Inhalation

Based on the results of the study presented classification for repeated exposure via inhalation is not required in the absence of toxicologically significant findings after rats were exposed for 7 h per day, 5 days per week for 50 days