Piperonal

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:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference 1

Reference Type:

publication

Title:

A Comparison of the Toxicity of Some Allyl, Propenyl, and Propyl Compounds in the Rat

Author:

Taylor J.M. et al.

Year:

1964

Bibliographic source:

Toxicology and Applied Pharmacology, 6(4), 378-87.

Reference 2

Reference Type:

publication

Title:

Toxic properties of compounds related to safrole

Author:

Hagan E.C., Jenner P.M., Jones W.I., Fitzhugh O.G., Long E.L., Brouwer J.G., and Webb W.K.

Year:

1965

Bibliographic source:

Toxicology and Applied Pharmacology, 7(1), 18-24.

Reference 3

Reference Type:

publication

Title:

Unnamed

Year:

1964

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

No information on test article purity, oral gavage dose volume, or individual animal data.

GLP compliance:

no

Remarks:

Pre-dates GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Piperonal

EC Number:

204-409-7

EC Name:

Piperonal

Cas Number:

120-57-0

Molecular formula:

C8H6O3

IUPAC Name:

1,3-benzodioxole-5-carbaldehyde

Test material form:

not specified

Details on test material:

Piperonal was from Dodge and Olcot; piperonal (3,4-methylenedioxybenzaldehyde) as cited in the article

Test animals

Species:

rat

Strain:

Osborne-Mendel

Sex:

male/female

Details on test animals or test system and environmental conditions:

Osborne-Mendel or Sherman strain. Young, adult rats in the weight range 180-350 g were used.
Groups of ten young adult Osborne-Mendel rats evenly divided by sex were fasted for approximately 18 hours prior to treatment. Animals had access to water at all times, and the food was replaced in cages as soon as animals received their respective doses.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

The compounds were administered by stomach tube to rats fasted 18 hours.

Doses:

Not reported (25% solutions of the test item dissolved in corn oil were administered).

No. of animals per sex per dose:

five males and five females per dose

Control animals:

no

Details on study design:

Groups of 10 young adult Osborne-Mendel rats evenly divided by sex (five males and five females per dose) were fasted for approximately 18 hr prior to treatment. Then the rats were administered 25% piperonal in corn oil. All animals were maintained under close observation for recording toxic signs and time of death. Such observation was continued until animals appeared normal and showed weight gain. The observation period was one week.

Statistics:

no data

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 700 mg/kg bw

Based on:

test mat.

95% CL:

>= 2 350 - <= 3 100

Remarks on result:

other: calculated by the slope function with 95% confidence limits.

Mortality:

Deaths occurred from 2 hours to 5 days post-dosing

Clinical signs:

other: Tremors for several hours followed by depression and ataxia.

Gross pathology:

No data

Other findings:

No data

Any other information on results incl. tables

The reported LD50 value was 2700 mg/kg body weight (2350 -3100 mg/kg bw)

Slope function = 1.5 (1.1 -2.0)

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information under CLP REGULATION (EC) No 1272/2008 Criteria used for interpretation of results: other: REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

Conclusions:

The reported LD50 value was 2700 mg/kg body weight.

Executive summary:

Groups of 10 young adult Osborne-Mendel rats evenly divided by sex were fasted for approximately 18 hours prior to administration of piperonal as a 25% solution in corn oil. All animals were maintained under close observation for recording toxic signs and time of death.  Such observation was continued until animals appeared normal and showed weight gain. The observation period was one week. The calculated LD50 value was 2700 mg/kg body weight.