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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

No adverse effects were observed that could be related to the treatment with the test substance. Under the study conditions, the NOEL was greater than the highest dose tested and determined to be >2500 mg/kg bw/day.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Study duration:
subchronic
Species:
rat
Quality of whole database:
Good quality

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

A study was conducted to determine the repeated dose toxicity of the structural analogue (99.61% purity) according to EPA OTS Guideline 798.2650. Male and female Sprague Dawley rats (10/sex/dose) were administered by gavage the following concentrations (dissolved in corn oil, at a volume of 10 mL/kg bw): 0, 250, 1250 and 2500 mg/kg bw/day for five days/week during 13 weeks. The homogeneity, stability and concentrations of dosing suspensions were analysed and were within acceptable values. Mortality was checked twice daily. Clinical signs were recorded daily and detailed observations were realised once each week. Body weights and body weight gains and food consumption were measured weekly. Ophthalmic examinations (indirect ophthalmoscope) were made prior to the start of dosing and prior to sacrifice. Haematology following an overnight fasting (retro-orbital sinus) comprised measurements for AST, ALT, total protein, gamma glutamyl transferase, calcium, glucose, albumin, globulin (calculated), creatinine, total bilirubin, urea nitrogen, phosphorus, sodium, potassium and chloride. Clinical chemistry following an overnight fasting (retro-orbital sinus) comprised analyses of erythrocyte count and indices, haemoglobin, haematocrit, platelet count, total and differential leukocyte count. Gross pathology along with complete necropsy (gross examinations of lungs, liver, kidneys) were done for all animals. Organ weights were recorded for the liver, kidneys, spleen, brain with stem, heart, adrenals, testes and ovaries. Histopathology (lungs, liver, kidneys, spleen, trachea, oesophagus, stomach, intestine, brain with stem, eyes, exorbital lachrymal glands, zymbal glands, pituitary, salivary glands, heart and aorta, adrenals, thymic region, thyroid, nasopharyngeal tissues, vagina, mammary glands, testes and ovaries) was carried out on tissues saved in 10% neutral buffered formalin. Except for a blue coloration of the skin and/or tail of some animals, no adverse effects were observed that could be related to the treatment with the test substance. Under the study conditions, the NOEL was greater than the highest dose tested and determined to be >2500 mg/kg bw/day..

Justification for classification or non-classification

Based on the results of a repeated dose oral toxicity study in rat, no classification for this endpoint is required according to CLP (EC 1272/2008) criteria.​