Carvacrol-rich essential oil obtained from the leaves of Origanum spp., Labiatae, by distillation

Endpoint summary

Description of key information

Acute toxicity, oral in rats: LD50 = 1850 mg/kg bw (equivalent or similar to OECD 401, 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:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

Some housing conditions are not reported (temperature, humidity, air changes); lack of details on the test item; no (historical) control group

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Specific details on test material used for the study:

Name in the study report: origanium oil
Test article label: 72-206

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

No data

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

No data

Doses:

1.32, 2.02, 3.2 and 5 g/kg bw

No. of animals per sex per dose:

10/dose

Control animals:

no

Details on study design:

Animals were observed for 14 days.

Preliminary study:

Not applicable

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 850 mg/kg bw

Based on:

test mat.

95% CL:

> 1 500 - < 2 200

Mortality:

See table below

Clinical signs:

piloerection and lethargy

Other findings:

None

Distribution of mortality:

Dose (g/kg)	Total deaths	Day 1	Day 2	Day 3	Day 4	Day 5	Day 6	Day 7 and thereafter
1.32	1/10	1	0	0	0	0	0	0
2.02	6/10	5	0	0	0	1	0	0
3.2	9/10	4	3	2	0	0	0	0
5	10/10	6	2	1	0	0	1	0

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Under the test conditions, the oral LD50 of the test substance was determined to be 1850 mg/kg bw therefore it is classified as category 4 (H302) according to the Regulation (EC) N° 1272-2008 and GHS.

Executive summary:

In an acute oral toxicity study performed similarly to OECD guideline 401, single oral dose of 1320, 2020, 3200 or 5000 mg/kg bw of the undiluted test substance was administered to 10 rats/dose. Animals were then observed for mortality and clinical signs of toxicity for 14 days.

 

1/10, 6/10, 9/10 and 10/10 animals died at 1320, 2020, 3200 and 5000 mg/kg bw, respectively with signs of piloerection and lethargy.

 

Under the test conditions, the oral LD50 of the test substance was determined to be 1850 mg/kg bw therefore it is classified as category 4 (H302) according to the Regulation (EC) N° 1272-2008 and GHS.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

1 850 mg/kg bw

Quality of whole database:

Adequate for hazard assessment

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

In an acute oral toxicity study performed similarly to OECD guideline 401, single oral dose of 1320, 2020, 3200 or 5000 mg/kg bw of the undiluted test substancewas administered to 10 rats/dose. Animals were then observed for mortality and clinical signs of toxicity for 14 days.

 

1/10, 6/10, 9/10 and 10/10 animals died at 1320, 2020, 3200 and 5000 mg/kg bw, respectively with signs of piloerection and lethargy.

 

Under the test conditions, the oral LD50 of the test substance was determined to be 1850 mg/kg bw therefore it is classified as category 4 (H302) according to the Regulation (EC) N° 1272-2008 and GHS.

Justification for classification or non-classification

Harmonized classification:

The registered substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.

Self-classification:

Acute toxicity via Oral route:

Based on the available information, the registered substance is:

- classified as category 4 (H302) according to the Regulation (EC) No. 1272/2008 and GHS.

Acute toxicity via Dermal route:

Based on the available information, the registered substance is:

- not classified according to Regulation (EC) No. 1272/2008 and potentially classified as category 5 according to GHS.

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):

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 (Inhalation): This information is not available.

Based on its composition (> 10% of aspiration toxicants or hydrocarbons), the registered substance is classified for aspiration hazard category 1, H304 according to CLP Regulation and GHS.