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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 guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
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

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.

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