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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

Referenceopen allclose all

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).

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).