p-propylanisole

Acute Toxicity: oral

Administrative data

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

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1964

Report date:

1964

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

p-propylanisole

EC Number:

203-203-4

EC Name:

p-propylanisole

Cas Number:

104-45-0

Molecular formula:

C10H14O

IUPAC Name:

1-methoxy-4-propylbenzene

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.

Test animals

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.

Administration / exposure

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.

Results and discussion

Effect levels

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.

Applicant's summary and conclusion

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).