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Administrative data

Description of key information

The LD50 value derived from the acute oral toxicity study with Tetrahydro-4-methyl-2-(2-methylpropyl) -2H-pyran-4-ol is > 2000 mg/kg bw. The dermal LD50 is > 2000 mg/kg bw.

Key value for chemical safety assessment

Additional information

Oral route:

In an acute oral toxicity study according to OECD TG 401 and GLP, the LD50 in rats was determined to be greater than 2000 mg/kg bw. Bodyweight development was not impaired. No deaths occured and the clinical symptoms described were pilo-erection, increased salivation, abnormal body carriage (hunched posture), abnormal gait (waddling), lethargy, decreased respiratory rate, ptosis and pallor of the extremities. Recovery of all rats was complete by day 3.

Dermal route:

The acute dermal toxicity of Tetrahydro-4-methyl-2-(2-methylpropyl) -2H-pyran-4-ol was studied in rabbits according to OECD TG 402 with following two deviations:

1. Six healthy albino rabbits (4 males, 2 females) were used for the study instead of 10.

2. Skin application site was abraded on 50 % of the animals to enhance dermal penetration.

All animals survived the 2000 mg/kg bw dermal application. Physical signs of few feces and yellow nasal discharge were noted during the study. Body weight development was normal. Dermal reactions, slight to moderate on day 1, were absent to severe on day 7 and absent on day 14. Necropsy results were normal. Even though the test substance was also applied to abraded skin (representing a more severe condition compared to intact skin), dermal reactions were completely reversible after 14 days. In summary, no potential of acute dermal toxicity in rabbits was observed for Tetrahydro-4-methyl-2-(2-methylpropyl) -2H-pyran-4-ol at 2000 mg/kg bw.

Inhalation route:

No acute inhalation toxicity studies are available. Due to the low acute oral and dermal toxicity of Tetrahydro-4-methyl-2-(2-methylpropyl) -2H-pyran-4-ol, no systemic toxicity after inhalation at dose levels relevant for classification and labelling is expected.

Justification for classification or non-classification

Based on the results of the acute oral and dermal key toxicity studies, Tetrahydro-4-methyl-2-(2-methylpropyl) -2H-pyran-4-ol is not subjected to classification and labelling for acute toxic effects according to Directive 67/548/EEC and Regulation 1272/2008/EC.