Myrtus communis, ext.

Endpoint summary

Description of key information

Acute toxicity, oral: LD50 > 5000 mg/kg bw (K, Rel.2).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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.

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

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

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

No data

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

Preliminary study:

None

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

None

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).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

Only basic data given in the available study. However, only one death out of ten animals 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.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute toxicity: via oral route:

A key study was identified (Moreno, 1979, Rel. 2). In this limit acute oral toxicity study, 10 rats were administered a single oral dose of test material of 5000 mg/kg bw. The animals were observed for mortality for 14 days.

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.  

Justification for selection of acute toxicity – oral endpoint
Only one study available

Justification for classification or non-classification

Harmonized classification:

Myrtle oil has no harmonized classification according to the Regulation (EC) No. 1272/2008.

Self-classification:

Acute toxicity via Oral route:

Based on the available information, Myrtle oil is:

- not classified according to the Regulation (EC) No. 1272/2008 as the LD50 is greater than 2000 mg/kg bw

- not classified according to the Directive 67/548/EEC as the LD50 is greater than 2000 mg/kg bw.

Acute toxicity via Dermal route: This information is not available

Acute toxicity via Inhalation: This information is not available.

Specific target organ toxicity: single exposure (Oral):

The classification criteria according to the Annex VI of the Regulation (EC) No. 1272/2008 as specific target organ toxicant (STOT) – single exposure, oral are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value (oral) for a Category 1 classification (C ≤ 300 mg/kg bw) and at the guidance value (oral) for a Category 2 classification (2000 mg/kg bw ≥ C > 300 mg/kg bw). No classification is required.

Specific target organ toxicity: single exposure (Dermal): This information is not available.

Specific target organ toxicity: single exposure (Inhalation): This information is not available.

Based on its composition (> 10% of aspiration toxicants, i.e. limonene, pinene), Myrtle oil should be classified for aspiration hazard:

- H304,May be fatal if swallowed and enters airways according to the regulation (EC) No. 1272/2008

- Xn, R65, Harmful: may cause lung damage if swallowed according to the Directive 67/548/EEC.

Source: ECHA disseminated dossiers

-Pinene:

http://apps.echa.europa.eu/registered/data/dossiers/DISS-9d952924-c8ed-4614-e044-00144f67d249/DISS-9d952924-c8ed-4614-e044-00144f67d249_DISS-9d952924-c8ed-4614-e044-00144f67d249.html

- Limonene:

http://apps.echa.europa.eu/registered/data/dossiers/DISS-9eb16d5d-b83e-2831-e044-00144f67d031/DISS-9eb16d5d-b83e-2831-e044-00144f67d031_DISS-9eb16d5d-b83e-2831-e044-00144f67d031.html