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Description of key information

Based on two acute toxicity studies in rat (oral and dermal), 28 day oral study in rats and oral (daily) Study of Fertility and Early Embryonic Development (rat).  Also consideration of the substances water solubility, partition coefficient , molecular mass and particle size.

Key value for chemical safety assessment

Bioaccumulation potential:
low bioaccumulation potential
Absorption rate - oral (%):
100
Absorption rate - dermal (%):
100

Additional information

oral: evidence presented by the acute oral toxicity study indicates that the substance is absorbed following administration in arachis oil with systemic effects noted at the high dose; increased liver enzymes, increase in blood cholesterol, increased liver weight with associated microscopic hepatocyte hypertrophy. Additionally, no toxicologically significant effects were observed on reproductive or developmental parameters in the exposed animals.

The water solubility, partition coefficient and molecular mass all indicate that this substance will be bioavailable via the oral route.

Inhalation: The particle size distribution indicates that there is limited potential for exposure by this route.

Dermal absorption: Results from in vivo irritation and dermal toxicity studies, in addition to the physical parameters of molecular weight and log Pow, indicate that the substance can penetrate the stratum corneum and is systemically available from dermal exposure.

Metabolism:

No specific metabolism studies have been undertaken however there is limited evidence from the 28 day study to indicate that the substance is undergoing hepatic metabolism (increase in ALAT and liver weight, incidence of microscopic hepatocyte hypertrophy).

Distribution: No specific distribution studies have been conducted, however limited evidence from the 28 Day study (changes in haematological parameters (Hb, RDW, counts of neutrophils, lymphocytes, reticulocytes), clinical biochemical parameters (prot, chol, Ca, Cl, ALAT), urinalysis (volume, glu, Na, pH), organ weight of liver, prostate gland, uterus, thymus (f), and microscopic findings (hypertrophy in cells of thyroid, trachea, liver, adrenals, haematopoiesis-spleen). ) indicates that the substance is distributed throughout the body.

Excretion: No specific excretion studies have been conducted however the physical characteristics (MW, water solubility and partition coefficient), changes to the clinical chemistry (Ca, Cl) and urinanalysis profile (volume, Na, pH) of treated animals would suggest that the substance or its metabolites interact with, or are excreted by the kidneys.