Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

oral
rat (28-day): NOAEL (m/f): 150-1000 mg/kg (BASF AG 1991, OECD 407)
dermal
Actually, there is no information available to cover this endpoint.
inhalation
Actually, there is no information available to cover this endpoint

Key value for chemical safety assessment

Additional information

oral

Tetrahydrothiopyran-3-aldehyd was administered to 30 Wistar rats (15 males and 15 females) by gavage for 4 weeks (21 times). A control group (5 per sex) was dosed with vehicle alone (olive oil). The doses were 15 mg/kg body weight, 150 mg/kg body weight and 1,000 mg/kg body weight. Repeated administration of the test substance caused decreased food consumption (only in the first week), decreased body weight gain in males during the course of the study (significantly decreased only the first week), increased water consumption for the last two weeks, salivation after application (not detectable 10 minutes after that), increased alkaline phosphatase in the female animals, decreased chloride in the female animals and statistically significantly increased absolute and relative liver weights in the female animals in the highest dosing group. Diffuse or focal thickening of the forestomach’s wall in both sexes (macroscopically), hyperkeratosis and/or parakeratosis and epithelial hyperplasia in the forestomach of all males and females as well as slight centrolobular single cell necrosis of the liver in both sexes were noted at necropsy. At the mid dose level only minimal hyperkeratosis and epithelial hyperplasia in the forestomach were noted in both sexes, the low dose level produced no findings at all. The observed effects in the forestomach of the rats in the 150 mg/kg body weight group are considered as treatment-related due to the irritative property of the substance but no signs of systemic toxicity have been observed. Based on the results obtained during this oral toxicity study the “no adverse effect level” of Tetrahydrothiopyran-3-aldehyd is in the range lower than 1.000 mg/kg body weight and greater than 150 mg/kg body weight, the NOEL is defined at 15 mg/kg bw and day.

 

dermal

Actually, there is no information available to cover this endpoint.

 

inhalation

Actually, there is no information available to cover this endpoint.

Justification for classification or non-classification

oral

Regarding the results of these studies in rats, the subacute NOAEL of the test substance is found to be at 150 mg/kg body weight and the NOEL at 15 mg/kg body weight due to the overall no effects observed. Based on these results and applying the criteria of the EU and GHS system, the test substance is not classified for repeated dose toxicity. Based on the CLP criteria for classification and labeling the test substance needs not to be labeled.

 

dermal

Actually, there is no information available to cover this endpoint.

 

inhalation

Actually, there is no information available to cover this endpoint.