Registration Dossier
Registration Dossier
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EC number: 400-820-2 | CAS number: 84268-33-7
Specific investigations: other studies
Administrative data
- Endpoint:
- specific investigations: other studies
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study obtained through inquiry process; SNIF file obtained from ECHA.
Data source
Reference
- Reference Type:
- other: SNIF
- Title:
- Unnamed
- Year:
- 1 986
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Deviations:
- not applicable
- Principles of method if other than guideline:
- According to in-house protocol using recognised biochemical and morphological techniques to investigate the effects of the test substance and its metabolite on selected biochemical and morphological parameters of the male rat liver.
- GLP compliance:
- not specified
- Type of method:
- in vivo
Test material
- Reference substance name:
- Body responsible for the test
- IUPAC Name:
- Body responsible for the test
- Test material form:
- not specified
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% carboxymethylcellulose
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 14 days
- Frequency of treatment:
- Daily for 14 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
10, 50 and 200 mg/kg
Basis:
no data
- No. of animals per sex per dose:
- 5
- Control animals:
- other: 10 animals per dose level
Results and discussion
- Details on results:
- Signs of toxicity:
No deaths and no signs of toxicity. Reduced body weight gain was noted in animals treated with 50 or 200 mg/kg metabolite.
Effects on liver:
Dose-related increase in absolute liver weight at 10 mg/kg and above for both substances (80-90% above controls at highets dose).
Ultrastructural examination of animals treated with 200 mg/kg revealed a striking proliferation of peroxisomes, particularly with metabolite. A marginal proliferation of smooth endoplasmic reticulum was noted with metabolite.
There was a dose-dependent and statistically high significant increase in peroxisomal beta-oxidation at 10 mg/kg and above for both substances. Increased cytochrome P-452 and decreased activity of UDP-glucuronosyltransferase and glutathione S-transferase were also noted with both substances.
Applicant's summary and conclusion
- Conclusions:
- The liver effects seen with both substances were very similar to those found after repeated administration of known peroxisome proliferators to rats. Both substances can be classified as potent peroxisome proliferators in the rat.
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