Myrtus communis, ext.

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Pre-guideline and pre-GLP study. Only basic data given. However, only one death was observed at the dose level of 5000 mg/kg bw, which is 2.5 times more than the limit dose of the OECD 401/423/425. A repeat study is unlikely to show worse effects, therefore this study was considered sufficiently robust to cover this endpoint.

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:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Principles of method if other than guideline:

Standard acute method (limit test)

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Myrtus communis, ext.

EC Number:

282-012-8

EC Name:

Myrtus communis, ext.

Cas Number:

84082-67-7

IUPAC Name:

Myrtus communis, ext.

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): Myrte essence (Myrtle oil)
- Sample marking: 78-53

Test animals

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

No data

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

not specified

Details on oral exposure:

No data

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

Total animals: 10

Control animals:

no

Details on study design:

No data

Statistics:

None

Results and discussion

Preliminary study:

None

Effect levels

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Mortality (1/10) was observed on Day 6 at 5000 mg/kg bw

Mortality:

- Mortality (1/10) was observed on Day 6 at 5000 mg/kg bw

Clinical signs:

- At 5000 mg/kg bw, ataxia and lethargy were noted in five or more animals. Isolated instances of chromorhinorrhea, dyspnea, ptosis, diarrhea, and piloerection were also noted.

Body weight:

No data

Gross pathology:

- No macroscopic abnormalities were observed in 7/10 animals.
- The following lesions were noticed in some animals: red exudate in nose/mouth, brown exudate in anogenital region, reddish/yellowish and bloated intestines, reddish areas in stomach, dark liver, lungs, kidney and spleen, mucus-like covering in heart and lungs, white nodules in lungs and pale liver were noticed.

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions, the oral LD50 for Myrte essence (Myrtle oil) is higher than 5000 mg/kg bw in rats therefore it is not classified according to the Annex VI to the Directive 67/548/EEC and the Regulation (EC) No. 1272/2008 (CLP).

Executive summary:

In an acute oral toxicity (limit test) study, a group of 10 rats were given a single oral dose of Myrte essence (Myrtle oil) at 5000 mg/kg bw. Animals were then observed for mortality and clinical signs for 14 days and were all sacrificed for macroscopic examination.

Mortality (1/10) was observed on Day 6 at 5000 mg/kg bw. At 5000 mg/kg bw, ataxia and lethargy were noted in five or more animals. Isolated instances of chromorhinorrhea, dyspnea, ptosis, diarrhea, and piloerection were also noted. No macroscopic abnormalities related to treatment were observed during necropsy. In this study, the oral LD50 of test item was higher than 5000 mg/kg bw in rats.  

Under the test conditions, the oral LD50 for Myrte essence (Myrtle oil) is higher than 5000 mg/kg bw in rats therefore it is not classified according to the Annex VI to the Directive 67/548/EEC and the Regulation (EC) No. 1272/2008 (CLP).