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Toxicological information

Acute Toxicity: oral

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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

Referenceopen allclose all

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 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 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

Reference
Name:
Unnamed
Type:
Constituent
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:
Tremors for several hours followed by depression and ataxia.
Body weight:
Survivors had normal body weights
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.