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EC number: 201-939-0 | CAS number: 89-78-1
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: carcinogenicity study
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
Materials and methods
- Principles of method if other than guideline:
- A bioassay of dl-menthol for possible carcinogenicity was conducted by administrating the test chemical in feed to Fisher 344 rats.
Groups of 50 rats of each sex were administrated dl-menthol at one of the following doses, either 3750 or 7500 ppm for 103 weeks, then observed for 1 or 2 additional weeks. Matched controls consisted of 50 untreated rats of each sex. All surviving rats were killed at 105 weeks. - GLP compliance:
- not specified
Test material
- Reference substance name:
- Menthol
- EC Number:
- 201-939-0
- EC Name:
- Menthol
- Cas Number:
- 89-78-1
- Molecular formula:
- C10H20O
- IUPAC Name:
- 2-isopropyl-5-methylcyclohexanol
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
DL-menthol (CAS 89-78-1), USP-grade
- Source and lot/batch No.of test material: 2 batches test:
Lot No. 4-HTP-6
Lot No. Nl 1-26-74-2054
Identity confirmed
Batch 1:
2 impurites:
0.3 %
1.3 %
Batch 2:
0.2 % Impurity
OTHER SPECIFICS: USP-grade
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 103 w
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
3750 or 7500 ppm (= ca. 188 or 375 mg/kg bw/d)
Basis:
nominal in diet
- No. of animals per sex per dose:
- 50 rats of either sex/dose
- Control animals:
- other: untreated diet containing 2 % corn oil
- Details on study design:
- Post-exposure period: 2 w
Results and discussion
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 375 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Remarks on result:
- other: 375 mg/kg bw was the highest applied dose
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 188 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: based on slightly reduced body weight at 375 mg/kg bw
- Remarks on result:
- other: 375 mg/kg bw was the highest applied dose
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Mean body weights of dosed rats were only slightly lower than those of corresponding controls. No other clinical signs related to administration of the dl-menthol were noted in the dosed groups of animals. Survival at the end of the bioassay was at least 62% in all dosed and control groups of animals and sufficient numbers of animals were at risk for the development of late-appearing tumors.
In both dose groups no increased incidence of neoplasms compared to the controls were observed.
Applicant's summary and conclusion
- Conclusions:
- dl-menthol was neither toxic nor carcinogenic to Fisher 344 rats
- Executive summary:
A bioassay of dl-menthol for possible carcinogenicity was conducted by administrating the test chemical in feed to Fisher 344 rats.
Groups of 50 rats of each sex were administrated dl-menthol at one of the following doses, either 3750 or 7500 ppm for 103 weeks, then observed for 1 or 2 additional weeks. Matched controls consisted of 50 untreated rats of each sex. All surviving rats were killed at 105 weeks.
Mean body weights of dosed rats were only slightly lower than those of corresponding controls. No other clinical signs related to administration of the dl-menthol were noted in the dosed groups of animals. Survival at the end of the bioassay was at least 62% in all dosed and control groups of animals and sufficient numbers of animals were at risk for the development of late-appearing tumors.
In both dose groups no increased incidence of neoplasms compared to the controls were observed.
Based on the histopathologic examination, dl-menthol was neither toxic nor carcinogenic to Fisher 344 rats under the conditions of this bioassay.
The NOAEL in these study can be considered with 375 mg/kg bw/d for male rats. For female rats the NOAEL is 188 mg/kg
based on slightly reduced body weight at 375 mg/kg bw.
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