Cardamom, ext.

Endpoint summary

Description of key information

Acute toxicity, oral: LD50 = ca. 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:

1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given, but considered sufficiently reliable for the purpose of hazard assessment

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:

- Duration of observation period following administration: 14 days

Statistics:

None

Preliminary study:

None

Sex:

not specified

Dose descriptor:

LD50

Effect level:

ca. 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Mortality was observed in 5/10 animals at 5000 mg/kg bw.

Mortality:

- Mortality was observed in 5/10 animals at 5000 mg/kg bw (2 animals died on Day 1 and 3 animals died on Day 2).

Clinical signs:

other: - At 5000 mg/kg bw, lethargy, slow response and 6/10 animals showed negative righting reflex.

Gross pathology:

No data

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 Cardamon oil is ca. 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 Cardamon oil at 5000 mg/kg bw. Animals were then observed for mortality and clinical signs for 14 days.

Mortality was observed in 5/10 animals at 5000 mg/kg bw (2 animals died on Day 1 and 3 animals died on Day 2). At 5000 mg/kg bw, lethargy, slow response and 6/10 animals showed negative righting reflex. In this study, the oral LD50 of test item was ca. 5000 mg/kg bw in rats.  

Under the test conditions, the oral LD50 for Cardamon oil is ca. 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, 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, 1973, 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 was observed in 5/10 animals at 5000 mg/kg bw (2 animals died on Day 1 and 3 animals died on Day2). At 5000 mg/kg bw, lethargy, slow response and 6/10 animals showed negative righting reflex. In this study, the oral LD50 of test item was ca. 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:

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

 

Self-classification:

Acute toxicity via Oral route:

Based on the typical composition provided by the Lead Registrant, Cardamom oil is:

- not classified according to the Regulation (EC) No. 1272/2008 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 availanle

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

 

Based on its hydrocarbon content, Cardamom oil should be classified for aspiration hazard:

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