Myristica fragrans, ext.

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

No data

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Data from literature, insufficient details on methods provided.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

publication

Title:

Food Flavourings and Compounds of Related Structure; I. Acute Oral Toxicity

Author:

Jenner PM, Hagan EC, Taylor JM, Cook EL and Fitzhugh OG

Year:

1964

Bibliographic source:

Food Cosmet. Toxicol. Vol. 2, pp. 327-343, 1964

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Guideline not specified, insufficient data to determine whether tests were conducted in accordance with requirements of guideline. The methods described seem to be consistent with the deleted OECD guideline 401. The following is mentioned:
Groups of 10 young adult Osborne-Mendel rats evenly divided by sex were fasted for approximately 18 hr 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. All doses were given by intubation. All animals were maintained under close observation for recording toxic signs and time of death. Such observation was continued until animals appeared normal or showed weight gain. The usual observation period was 2 weeks; in a few cases, where no acute toxic signs were seen, the animals were observed for only one week. LD50's were computed by the method of Litchfield & Wilcoxon (1949).

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Myristica fragrans, ext.

EC Number:

282-013-3

EC Name:

Myristica fragrans, ext.

Cas Number:

84082-68-8

Molecular formula:

Unspecified (UVCB)

IUPAC Name:

Nutmeg Oil (Myristica fragrans, ext.)

Details on test material:

- Name of test material (as cited in study report): Nutmeg Oil
- Physical state: liquid
- Other: A commercially available material was used, no attempt was made to secure chemically pure compounds.

Test animals

Species:

rat

Strain:

Osborne-Mendel

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

No data

No. of animals per sex per dose:

5

Control animals:

not specified

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 620 mg/kg bw

Based on:

not specified

95% CL:

>= 2 200 - <= 3 120

Remarks on result:

other: Slope function 1.3 (95% CI 1.2-1.5)

Any other information on results incl. tables

Mortality: Death time 4-18 hr.

Clinical signs: Depression soon after receiving treatment, scrawny appearance for several days.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of Nutmeg Oil for rats was found to be 2620 mg/kg bodyweight.

Executive summary:

The acute oral toxicity of Nutmeg Oil to rats was investigated. 10 animals per concentration were used, the substance was administered orally via gavage. The LD50 was found to be 2620 mg/kg body weight. Therefore, the substance does not need to be classified as hazardous according to the EU classification criteria set out in 67/548/EEC.