Registration Dossier
Registration Dossier
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EC number: 935-783-6 | CAS number: -
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well documented and scientifically acceptable study. Although some details on the extraction, analytical conditions and the investigated tissue weights are missing in the biocide dossier the reliability of 2 assumed in the dossier is also given here.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
- Objective of study:
- distribution
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The test substance was extracted from liver and fat tissue of the abdominal cavity of rats which received different doses of the unlabelled test substance in diet. The concentration was assessed using gas chromatography. The limit of detection was 0.6 and 1.4 ppm (mg/kg) for fatty tissue and liver, respectively.
- GLP compliance:
- no
Test material
- Reference substance name:
- Chlorocresol
- EC Number:
- 200-431-6
- EC Name:
- Chlorocresol
- Cas Number:
- 59-50-7
- Molecular formula:
- C7H7ClO
- IUPAC Name:
- 4-chloro-3-methylphenol
- Details on test material:
- - Name of test material (as cited in study report): Preventol CMK
- Analytical purity: 99.9%
- Lot/batch No.: Not reported
- Stability under test conditions: Not reported
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- rat
- Strain:
- other: Wistar TNO/W 74 rats
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Kirchborchen, Germany
- Age at study initiation: 4-5 weeks
- Weight at study initiation: 45 - 55 g
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Duration and frequency of treatment / exposure:
- 13 weeks
Doses / concentrations
- Remarks:
- Doses / Concentrations:
150, 500, 1500 ppm
- No. of animals per sex per dose / concentration:
- 12 males/does
- Control animals:
- no
- Details on dosing and sampling:
- PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled: liver, fat tissue of the the abdominal cavity
- Time and frequency of sampling: 1, 4, 8 and 13 weeks after start of treatment
Results and discussion
Main ADME results
- Type:
- distribution
- Results:
- No cummulation of the test substance in liver and fat tissue.
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- The study design was not intended to investigate details on the absorption of the test substance.
- Details on distribution in tissues:
- No test substance was detected within samples of the liver tissue, while in samples of the fat tissue the test substance was detected occasionally. No correlation was found between the applied dose and the amount of test substance in the samples. No cumulative effect was observed. For details see Table 1 in "Any other information on results"
- Details on excretion:
- The study design was not intended to investigate details on the excretion of the test substance.
Metabolite characterisation studies
- Metabolites identified:
- not measured
Any other information on results incl. tables
The test relies on non-labelled test material which might impair the sensitivity of the method. However, the detection limit using the employed method is in the range of 0.6-1.4 ppm and can be regarded sufficiently sensitive. Experience with other phenolic compounds shows that the molecules are readily conjugated to glucuronic acid and sulphate. The conjugates are then rapidly excreted via urine. Thus, accumulation in tissues is unlikely because of the intrinsic properties of the parent compound.
Table 1: Preventol CMK concentration in fat and liver tissue
Dose group [ppm] |
Sampling time [weeks] |
Tissue concentration [nmol/g]* |
|
Fatty tissue |
Liver tissue |
||
150 |
1 |
< LOD |
< LOD |
4 |
11 |
|
|
8 |
< LOD |
< LOD |
|
13 |
< LOD |
< LOD |
|
500 |
1 |
15 |
< LOD |
4 |
13 |
< LOD |
|
8 |
< LOD |
< LOD |
|
13 |
< LOD |
< LOD |
|
1500 |
1 |
10 |
< LOD |
4 |
10 |
< LOD |
|
8 |
< LOD |
< LOD |
|
13 |
< LOD |
< LOD |
|
LOD in liver tissue: 10 nmol/g, LOD in fat tissue: 4 nmol/g, *Average of non-zero values
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
