Cymbopogon nardus, ext.

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

30 Oct 1971 - 14 Nov 1971

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

pre-GLP, in vivo study study similar to guideline, described in limited detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1971

Report date:

1971

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Remarks:

pre-GLP

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Cymbopogon nardus, ext.

EC Number:

289-753-6

EC Name:

Cymbopogon nardus, ext.

Cas Number:

89998-15-2

IUPAC Name:

Essential oil of Citronella obtained from the aerial parts of Cymbopogon nardus, (Poaceae), by steam distillation

Test material form:

liquid

Specific details on test material used for the study:

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: tested as supplied

Test animals

Species:

rat

Strain:

other: Sherman-Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Fasting period before study: 24 hours
- Diet (e.g. ad libitum): ad libitum after dosing
- Water (e.g. ad libitum): ad libitum after dosing
- Acclimation period: one week

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

Mortality was observed in 3 female rats during the first day after exposure.

Clinical signs:

other: Diuresis, morbidity, pilo erection, prostration, coma

Gross pathology:

no data

Applicant's summary and conclusion

Interpretation of results:

other: Not acute toxic

Remarks:

in accordance with EU CLP (EC 1272/2008 and its updates)

Conclusions:

The acute oral toxicity test showed an LD50 of > 5000 mg/kg bw. Based on this result, the substance is considered to be not acute toxic via the oral route in accordance with EU CLP (EC 1272/2008 and its updates)

Executive summary:

Citronella Nardus oil is tested for acute oral toxicity in a study performed similar to OECD TG 401. Five Sherman-Wistar rats per sex, per dose, were exposed to 5000 mg/kg bw test substance via oral gavage. Before dosing the animals were starved for 24 hours. Afterwards, the animals were allowed food and water ad libitum during a fourteen day observation.

In this study three (female) animals died. Diuresis, morbidity, pilo erection, prostration, coma were observed. The acute oral toxicity test showed a LD50 of > 5000 mg/kg bw. Based on this result, the substance is considered to be not acute toxic via the oral route.