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- Experimental data of toxicological tests (unpublished)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

The data about toxicokinetics were derived from following study reports:
Study No. 27/07/1: Humic acids, sodium salts - Acute Oral Toxicity - Acute Toxic Class Method; VÚOS-CETA Report No. 07195, 2007.
Study No. 27/07/2: Humic acids, sodium salts - Acute Dermal Toxicity; VÚOS-CETA Report No. 07196, 2007.
Study No. 27/07/4: Humic acids, sodium salts - Acute Toxicity: Dermal Irritation/Corrosion; VÚOS-CETA Report No. 07183, 2007.
Study No. 27/07/5: Humic acids, sodium salts - Acute Toxicity: Eye Irritation/Corrosion; VÚOS-CETA Report No. 07184, 2007.
Study No. 27/07/6: Humic acids, sodium salts - Skin Sensitisation: Local Lymph Node Assay; VÚOS-CETA Report No. 07187, 2007.
Study No. 27/07/7: Humic acids, sodium salts - Repeated Dose 28-day Oral Toxicity Study; VÚOS-CETA Report No. 0855, 2008.
Study No. 27/07/14: Humic acids, sodium salts – Mikronucleus Study; VÚOS-CETA Report No. 0856, 2008.
Study No. 27/07/18: Humic acids, sodium salts - Reproduction/Developmental Toxicity Screening Test; VÚOS-CETA Report No. 09152, 2009.

Some toxicokinetic data were extract from toxicological databases.

1.1. Study No. 26/07/1: Humic acids, potassium salts - Acute Oral Toxicity - Acute Toxic
Class Method; VÚOS-CETA Report No. 07145, 2007.
1.2. Study No. 26/07/2: Humic acids, potassium salts - Acute Dermal Toxicity; VÚOS-CETA Report No. 07194, 2007.
1.3. Study No. 26/07/4: Humic acids, potassium salts - Acute Toxicity: Dermal Irritation/Corrosion; VÚOS-CETA Report No. 07181, 2007.
1.4. Study No. 26/07/5: Humic acids, potassium salts - Acute Toxicity: Eye Irritation/Corrosion; VÚOS-CETA Report No. 07182, 2007.
1.5. Study No. 26/07/6: Humic acids, potassium salts - Skin Sensitisation: Local Lymph Node Assay; VÚOS-CETA Report No. 0186, 2007.
1.6. Study No. 26/07/7: Humic acids, potassium salts - Repeated Dose 28-day Oral Toxicity Study; VÚOS-CETA Report No. 0857, 2008.
1.7. Study No. 26/07/14: Humic acids, potassium salts – Mikronucleus Study; VÚOS-CETA Report No. 0858, 2008.
1.8. 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 described for the mouse, rat, rabbit and chickens after oral, dermal, skin, eye, intracardiallyand subcutaneously administration, confirm that absorption of the substance occurs by these uptake routes. The test substance is a contact allergen in mouse.

On the basis of information from databases is evidently, that test substance is fast absorbed after intravascular administration. After extra vascular administration (subcutaneously, into the stomach), test substance is absorbed with more slow rate.

Effect on haematogenesis and negative effect on urine excretion system were found out in the study after repeated administration of the test substance into stomach. Test substance is absorbed from digestive tract, affected haemocoagulation and presumably is eliminated by kidneys.

Results of reproduction toxicity study showed that the test substance is observed from the digestive tract enters the reproductive system males and females - decreased sperm motility, increased percentage of affected sperms, increased vaginal hyperplasia, but not affected the course of pregnancy and development of pups.