Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
genetic toxicity in vivo, other
Remarks:
In vivo Single Cell Gel/Comet Assay
Type of information:
experimental study planned
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out : Base terpenica
- Name of the substance for which the testing proposal will be used [if different from tested substance] : N/A

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies : Not available.
- Available non-GLP studies : Not available.
- Historical human data: Not available.
- (Q)SAR: Not available.
- In vitro methods: In vitro methods are possitive
- Weight of evidence : Not available.
- Grouping and read-across : Not available. Substance UVCB.

CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- One of the in vitro studies of genetic toxicity is positive, so according annex XI of REACH Regulation it is necessary to carry out an in vivo assay.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed: In vivo Single Cell Gel/Comet Assay – OECD 489

Data source

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 489 (In vivo Mammalian Alkaline Comet Assay)
GLP compliance:
yes
Type of assay:
other: IN VIVO SINGLE CELL GEL/COMET ASSAY

Test material

Constituent 1
Chemical structure
Reference substance name:
mezcla de terpenos procedentes de la rectificación del Dihidromircenol.
EC Number:
947-968-9
Molecular formula:
C10H18
IUPAC Name:
mezcla de terpenos procedentes de la rectificación del Dihidromircenol.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Duration of treatment / exposure:
2 treatments at approximately 24 hour intervals
Post exposure period:
2-6 hours after the final administration
Doses / concentrationsopen allclose all
Dose / conc.:
2 000 mg/kg bw/day (nominal)
Dose / conc.:
1 000 mg/kg bw/day (nominal)
Dose / conc.:
500 mg/kg bw/day (nominal)
No. of animals per sex per dose:
5 males* per treated group
3 male animals for positive control group

both sexes should be considered if any existing toxicity, metabolism or exposure data indicate a toxicologically meaningful sex difference.

Examinations

Tissues and cell types examined:
Liver (other tissues/organs can be selected depending on the proposed use for exposure to the test substance)
Details of tissue and slide preparation:
150 cells analysed per tissue (50 cells scored per each of three replicate slides)
Evaluation criteria:
number of heavily damaged cells (hedgehogs, clouds, ghost cells)
% tail intensity and tail moment

Results and discussion

Applicant's summary and conclusion