Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
other: evaluation
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Materials and methods

Objective of study:
toxicokinetics

Results and discussion

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): no bioaccumulation potential based on study results
Executive summary:

Detailed literature search about toxicokinetic behaviour of the substance Versalovy sarlatDPEK (C.I. Pigment Red 255) was performed. Because no relevant toxicokinetic references were found, about behaviour of the test substance in organism of experimental animals was presumed only from results of toxicological testing, which was performed previously.

The slight systemic effect without mortality was described aftersingle oral administrationof the substance Versalovysarlat DPEKto rats. It is not possible to rule out absorption of the test substance from digestive tract after single administration of the test substance in dose level 5000 mg/kg.

The mutagenic influence on erythrocyte was not documented after single exposure of the dose level 5000 mg/kg.

Aftersingle applicationof test substance to theskinof rats or rabbits, systemic toxic effects were not detected - the substance obviously does not penetrate through the skin after acute exposure. No irritation potential was found out after application on skin of animals.

The test substance is not a skin sensitizer.

Aftersingle applicationof the substance to conjunctival sac of the rabbit eye no changes were recorded — the substance is not irritating to the eye. Systemic toxic effects were not described - the test substance does not penetrate to the body after acuteeye exposure.

 

Based on results ofrepeated administrationof the test substance -28-day studyin rats, it could be deduced that the test substance is not absorbed from gastrointestinal tract and had not toxic effect.

Results ofReproduction/Developmental studyin rats revealed that the test substance Versalovy sarlat DPEK had influence on parental males - decreased weight of prostate gland and changed motility of sperms without effect on fertility of males.

There was no evidence that the substance could get through placenta and affect the embryo or fetus. Development of pups was unaffected.

 

Absorption

Absorption of Versalovy sarlat DPEK from the digestive system and its distribution throughout the body of experimental rats after exposition of the test substance at the dose 100 mg/kg/day was not noted. Some absorption should be presumed at the dose of 160 - 1000 mg/kg at least in males because non adverse changes were detected in Reproduction/ Developmental Toxicity Screening test.

There was no evidence that the substance could get through placenta and affect the embryo or fetus.

 

Excretion

Unabsorbed substance is excreted via faeces what is evidenced by red colouring of faeces. There is no information about the fate of potentially absorbed part of the substance.