Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
other: Report on Assessment of Toxicokinetic Behaviour on the basis of literature search and Estimation of Toxicikinetics on the basis of toxicological tests results.
Adequacy of study:
weight of evidence
Study period:
September 2009

Data source

Reference
Reference Type:
other: Assessment
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Results and discussion

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): no data
Toxicokinetics of the substance was evaluated from three sources:
- Experimental data of toxicological tests (unpublished)
- Literary data obtained from internet
- Data from toxicological databases – free and commercial

No adequate literature data were found.

The data about toxicokinetics were derived from following study reports:
Study No. 26/07/1: Humic acids, potassium salts - Acute Oral Toxicity - Acute Toxic Class Method; VÚOS-CETA Report No. 07145, 2007.
Study No. 26/07/2: Humic acids, potassium salts - Acute Dermal Toxicity; VÚOS-CETA Report No. 07194, 2007.
Study No. 26/07/4: Humic acids, potassium salts - Acute Toxicity: Dermal Irritation/Corrosion; VÚOS-CETA Report No. 07181, 2007.
Study No. 26/07/5: Humic acids, potassium salts - Acute Toxicity: Eye Irritation/Corrosion; VÚOS-CETA Report No. 07182, 2007.
Study No. 26/07/6: Humic acids, potassium salts - Skin Sensitisation: Local Lymph Node Assay; VÚOS-CETA Report No. 0186, 2007.
Study No. 26/07/7: Humic acids, potassium salts - Repeated Dose 28-day Oral Toxicity Study; VÚOS-CETA Report No. 0857, 2008.
Study No. 26/07/14: Humic acids, potassium salts – Mikronucleus Study; VÚOS-CETA Report No. 0858, 2008.
Study No. 26/07/18: Humic acids, potassium salts - Reproduction/Developmental Toxicity Screening Test; VÚOS-CETA Report No. 09156, 2009.

Executive summary:

The toxicokinetic behaviour was estimated on the basis the toxocological tests results.

The systemic effects were described after single oral administration of the substance to rats. The substance is absorbed from digestive system. After skin or eye single application systemic toxic effects were not detected – the test substance does not penetrate through the skin or eye.

Effect on blood parameters and on urine excretion system in 28-day oral study confirmed that the test substance is absorbed from digestive tract, enters the blood circulation and probably is eliminated by kidneys.

Results of reproduction toxicity study showed that the test substance is absorbed from the digestive tract and enters the reproductive system of males and females - influence on sperm quality and early intrauterine development of offspring.