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Registration Dossier
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EC number: 203-203-4 | CAS number: 104-45-0
Endpoint summary
Administrative data
Description of key information
The available data include two acute oral toxicity studies in rats.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1964
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
-
Principle of test: LD50 test in the rat.
LD50s were calculated using the Litchfield and Wilcoxon method. No further details reported. - GLP compliance:
- no
- Test type:
- other: Not specified
- Limit test:
- no
- Specific details on test material used for the study:
- The test substance was reported as 'dihydroanethole (1-methoxy-4-propylbenzene)'. No further details reported.
- Species:
- rat
- Strain:
- Osborne-Mendel
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Young adults, fasted for approximately 18 hours prior to treatment had access to water at all times and food was replaced after dosing.
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE
No vehicle was used in this study. The test substance was adminsitered undiluted.
CLASS METHOD
- Rationale for the selection of the starting dose: Justification of the starting dose was not provided. - Doses:
- No details reported.
- No. of animals per sex per dose:
- Groups of 10 rats (5 males and 5 females).
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: The typical observation period of 2 weeks after adminsitration. If no effects were seen during early phases of observation, animals were only monitored for 1 week.
- Necropsy of survivors performed: Not specified
- Other examinations performed: clinical signs, body weight - Statistics:
- LD50s were calculated using the Litchfield and Wilcoxon method.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 4 400 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 1.9
- Mortality:
- Death time = 4 hrs - 3 days
- Clinical signs:
- other: Depression, wet posterior.
- Gross pathology:
- No details reported.
- Other findings:
- No details reported.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- An oral LD50 of 4400 mg/kg bw in rats has been reported. Therefore, the test item is not classificable for acute toxicity according to CLP criteria (EC Regulation 1272/2008).
- Executive summary:
An oral LD50 of 4400 mg/kg bw in rats has been reported. Therefore, the test item is not classificable for acute toxicity according to CLP criteria (EC Regulation 1272/2008).
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1964
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Principle of test:
LD50 test in the rat.
LD50's calcuated using the Litchfield and Wilcocon method. No further details reported. - GLP compliance:
- no
- Test type:
- fixed dose procedure
- Limit test:
- no
- Specific details on test material used for the study:
- The test substance is reported under the alternative name 'dihydroanethole (1-methoxy-4-propylbenzene)'. No further details reported.
- Species:
- rat
- Strain:
- other:
- Remarks:
- Osborne Mendel or Sherman strain used (specific strain details not reported).
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Not reported
- Females (if applicable) nulliparous and non-pregnant: Not reported
- Age at study initiation: Reported as 'young'. No further details available.
- Weight at study initiation: 180-350 g
- Fasting period before study: 18 hours
- Housing: Not reported
- Diet (e.g. ad libitum): Not reported
- Water (e.g. ad libitum): Not reported
- Acclimation period: Not reported
No details on evironmental conditions were reported. - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE
The test item was administered undiluted. No vehicle was used.
MAXIMUM DOSE VOLUME APPLIED: Not reported
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: No starting dose justification was provided. - Doses:
- No details reported
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: Rats were observed until survivors retunred to normal weight and appearance.
- Frequency of observations and weighing: No details reported
- Necropsy of survivors performed: No details reported
- Other examinations performed: clinical signs and body weight - Statistics:
- LD50s were computed by Litchfield and Wilcoxon method.
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 4 400 mg/kg bw
- 95% CL:
- 1.9
- Mortality:
- Death time: 4 hrs - 3 days
- Clinical signs:
- other: Depression, porphyrin-like deposit around eyes and nose, wet posterior
- Gross pathology:
- No details reported.
- Other findings:
- In a follow-up study, histopathological examination fo the liver of rats (3/sex/dose) administered dihydroanethole an acute dose of 1470 mg/kg. Results gave a rating of 0.5 = liver had 1 or 2 necrotic lesions grayish or yellow in colour.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- An oral LD50 of 4400 mg/kg bw in rats has been reported. Therefore, the test item is not classificable for acute toxicity according to CLP criteria (EC Regulation 1272/2008).
- Executive summary:
An oral LD50 of 4400 mg/kg bw in rats has been reported. Therefore, the test item is not classificable for acute toxicity according to CLP criteria (EC Regulation 1272/2008).
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 4 400 mg/kg bw
- Quality of whole database:
- Both of the studies are considered to have a reliability score of 2.
Additional information
Justification for classification or non-classification
An oral LD50 of 4400 mg/kg bw in rats has been reported. Therefore, the test item is not classificable for acute toxicity according to CLP criteria (EC Regulation 1272/2008).
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