Cymbopogon nardus, ext.

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

28 Oct 1971 - 26 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

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Section 191.10 of the Final Order, Enforcement Regulations, Federal Register

Version / remarks:

Vol. 26, No. 155, P. 7336, 12 August 1961

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

no

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

Test animals

Species:

rabbit

Strain:

not specified

Remarks:

Albino

Sex:

not specified

Details on test animals or test system and environmental conditions:

no data

Administration / exposure

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5, 1.0, 2.0, 4.0, 8.0 mL/kg
- Concentration (if solution): undiluted
- Constant volume or concentration used: yno

Duration of exposure:

not reported

Doses:

0.5, 1.0, 2.0, 4.0, 8.0 mL/kg

No. of animals per sex per dose:

2 with intact skin, 2 with abraded skin

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

Statistics:

The mortality data were evaluated according to the Thompson Moving Average Method as described by Carrol S. Weil in his publication entitled "Tables for Convenient Calculation of Median-Effective Dose (LD50 or ED50) and Instructions in Their Use", which appeared in Biometrics, Vol. 8, No. 3, pp. 249-263, September 1952.

Results and discussion

Effect levels

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

4.7 mL/kg bw

Based on:

test mat.

Mortality:

Abraded skin: 1 animal at 4.0 mL/kg (day 1)
Intact skin: 2 animals at 8 mL/kg (day 1), 2 animals at 8 mL/kg (day 2)

Clinical signs:

other: Severe burns, morbidity, prostration, coma and death. (not indicated if symptoms were observed for animals with intact or abraded skin)

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Remarks:

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

Conclusions:

Based on the results, the LD50 was estimated 4.7 mL/kg bw (density 0.8996, Irwin et al 2017), which is equivalent to 4228.12 mg/kg bw. Therefore, the substance is considered to be not acute toxic via the dermal route in accordance with EU CLP (EC 1272/2008 and its updates).

Executive summary:

The acute dermal toxicity of Citronella nardus oil was examined in albino rabbits (method similar to OECD 402, pre-GLP). This study was conducted according to the requirements of Federal Register, 1961 (Vol 26, No. 155, pages 7333 -7341). The undiluted substance was applied at 0.5, 1.0, 2.0, 4.0 or 8.0 mL/kg onto the intact or abraded skin of the animals (2 animals per condition). During the 14 days observation one animal in the abraded skin group died 4.0 mL/kg (day 1), and 2 animals in the intact skin group died at 8 mL/kg (day 2). Furthermore severe burns, morbidity, prostration, coma and death were reported (intact or abraded skin was not specified). Based on the results, the LD50 was estimated 4.7 mL/kg bw. Therefore, the substance is considered to be not acute toxic via the dermal route.