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

Acute Toxicity: oral

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

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

EC Number:

947-697-6

Molecular formula:

Not relevant, UVCB substance

IUPAC Name:

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

Test material form:

liquid

Specific details on test material used for the study:

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

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: 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.

Results and discussion

Preliminary study:

Not applicable

Effect levels

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

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.