Coriander, ext.

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1971

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1971

Report date:

1971

Materials and methods

Principles of method if other than guideline:

Standard acute method

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Coriander, ext.

EC Number:

283-880-0

EC Name:

Coriander, ext.

Cas Number:

84775-50-8

Molecular formula:

Not applicable (UVCB)

IUPAC Name:

Essential oil of Coriandrum sativum L. (Apiaceae) obtained from seeds of coriander by steam distillation

Test material form:

liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source: Research Institute for Fragrance Materials, Inc.
- Physical state: Clear, colorless liquid
- Date of receipt: 05 May 1971

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 150-300 g
- Fasting period before study: Overnight
- Housing: Animals were individually housed.
- Diet: Commercial diets, ad libitum
- Water, ad libitum
- Fasted overnight

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

Test substance was prepared as 50% (w/v or v/v) solutions or suspensions in corn oil.
Doses in mL/kg were converted into mg/kg bw from the density of the test item of 0.8687.

Initially, 2 rats were given a single dose of 5 mL/kg equivalent to 4344 mg/kg bw, by gastric intubation. Following the dosing, the toxic signs and mortality were recorded. If no deaths occurred, 8 additional rats were given the same dose via the same route.
If 1 or 2 animals died within 48 hours in the first pair of animals or if more than 2 of the total of 10 rats died within the 14-day observation period, the LD50 value was determined using 6 groups of rats (5 rats/group) by giving graded dosage levels of the test compound via the same route.

Doses:

Primary screening test: Single dose of 5 mL/kg equivalent to 4344 mg/kg bw
Main test: Dose was 1.0 to 6.81 mL/kg equivalent to 868,7 mg/kg bw to 5916 mg/kg bw

No. of animals per sex per dose:

2 rats for the screening test, then 6 groups of rats (5 rats/group) for the main test

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: Following the dosing, the toxic signs and mortality were recorded at one and four hours and once daily thereafter for a total of 14 days.
- Necropsy of survivors performed: Yes; gross necropsy was performed on any animal that died during the study and on survivors which were killed by cervical dislocation at termination.

Statistics:

LD50 was calculated according to Horn's method (Horn, 1956).

Results and discussion

Preliminary study:

Mortality was observed in 1/2 animals in the primary screening test at 4344 mg/kg bw as well as bloody crust eyes and nose, ataxia, depression, hypopnea, lacrimation and salivation. In addition, darkened lungs, distended gastrointestinal tract and hemorrhagic lung occurred in rat that died during the screening test.
Therefore, the LD50 value was determined using 6 groups of rats (5 rats/group) by giving graded dosage levels of the test compound via the same route.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

3 588 mg/kg bw

Based on:

test mat.

Remarks on result:

other: confidence limits: 2154 to 5334 mg/kg bw

Mortality:

No mortality was reported in the main test.

Clinical signs:

other: other: No clinical signs were reported in the main test.

Gross pathology:

Hemorrhagic lung appeared to occur in rats killed at termination.
In addition, pale liver and kidney were observed in a few of the rats.

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

Under the test conditions, the oral LD50 for Coriander is 3588 mg/kg bw (confidence limits: 2154 to 5334 mg/kg bw) in rats, therefore it is not classified according to Regulation (EC) No. 1272/2008 (CLP).

Executive summary:

In an acute oral toxicity study, 2 rats were given a single dose of 5 mL/kg equivalent to 4344 mg/kg bw of test item by gastric intubation. Following the dosing, the toxic signs and mortality were recorded. As 1 animal died within 48 hours in the first pair of animals, the LD50 value was determined using 6 groups of rats (5 rats/group) by giving graded dosage levels (1.0 to 6.81 mL/kg equivalent to 868,7 mg/kg bw to 5916 mg/kg bw) of the test compound via the same route. Animals were then observed for mortality and clinical signs for 14 days and were all sacrificed for macroscopic examination.

 

Mortality was observed in 1/2 animals in the primary screening test at 4344 mg/kg bw as well as bloody crust eyes and nose, ataxia, depression, hypopnea, lacrimation and salivation. In addition, darkened lungs, distended gastrointestinal tract and hemorrhagic lung occurred in rat that died during the screening test. Therefore, the LD50 value was determined using 6 groups of rats (5 rats/group) by giving graded dosage levels of the test compound via the same route. No mortality and clinical signs were reported and hemorrhagic lung and some pale liver and kidney were observed at the necropsy. In this study, the oral LD50 of test item was 3588 mg/kg bw (C.I.2154-5916 mg/kg) in rats.

 

Under the test conditions, the oral LD50 for Coriander is 3588 mg/kg bw (confidence limits: 2154 to 5916 mg/kg) in rats, therefore it is not classified according to Regulation (EC) No. 1272/2008 (CLP).