Registration Dossier
Registration Dossier
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EC number: 403-530-4 | CAS number: 129423-54-7 PV-ECHTGELB HGR
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Poorly absorbed through skin and through gastrointestinal tract.
No information on distribution or metabolism.
Excreted mainly via faeces.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
Detailed literature search about toxicokinetic behaviour of the substance was performed. Since no ADME studies were found for this substance, the toxicokinetic evaluation is based on the results of existing toxicological tests.
The systemic effect was not described after single oral administration of the substance to rats. It is not possible to confirm absorption of the test substance from digestive tract after single administration of the test substance in dose level 2000 mg/kg.
The mutagenic influence on erythrocyte maturing in bone marrow was not documented after single p.o. exposure of the dose level 2000 mg/kg.
After single application of test substance to the skin of rats or rabbits, systemic toxic effects were not detected – the substance obviously does not penetrate through the skin after dermal exposure. No irritation potential was observed after application on skin of animals.
After single application of the substance into the conjunctival sac of the rabbit eye the local reversible effects (redness and swelling) was observed. These changes were mild character and disappeared in two days after application of the test substance. Based on the study results the substance is not irritating to the eye. During this study no systemic toxic effects were detected.
Based on results of 28 -day repeated administration of the test substance in rats, it could be deduced that the test substance is not absorbed from gastrointestinal tract and does not have toxic effect.
Results of reproduction/developmental study in rats revealed that the test substance at the highest dose level tested (1000 mg/kg bw/day) had influence on prostate gland of male rats – atrophic changes without effect on fertility of males. Impaired sperm quality of parental males was not observed. There was no evidence that the substance could get through placenta and affect the embryo or fetus. Development of pups was unaffected.
Absorption of the substance from the digestive system and its distribution throughout the body of experimental rats after exposition of the test substance at the dose range 62.5 – 400 mg/kg/day was not noted. Some absorption should be presumed at the dose of 1000 mg/kg bw/day at least in males because of prostate gland effects were detected in Reproduction/Developmental Toxicity Screening test.
The test substance is excreted mainly via faeces (yellow colouring of faeces, mucous membrane in caecum and stomach).
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