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Description of key information

Acute oral toxicity (similar to OECD TG 401): LD50 > 5000 mg/kg bw

Acute dermal toxicity (similar to OECD TG 402): LD50 = 4228.12 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
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
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
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

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
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:
Diuresis, morbidity, pilo erection, prostration, coma
Body weight:
no data
Gross pathology:
no data
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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Quality of whole database:
Though adverse effects were observed (3 out of 10 animals died at 5000 mg/kg bw), no dose descriptor was derived as the LD50 was > 5000 mg/kg bw.

Acute toxicity: via dermal route

Link to relevant study records
Reference
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.
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
Species:
rabbit
Strain:
not specified
Remarks:
Albino
Sex:
not specified
Details on test animals or test system and environmental conditions:
no data
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.
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:
Severe burns, morbidity, prostration, coma and death. (not indicated if symptoms were observed for animals with intact or abraded skin)
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
4 228.12 mg/kg bw

Additional information

Acute oral toxicity (similar to OECD TG 401):

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.

Acute dermal toxicity (similar to OECD TG 402)

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.

Justification for classification or non-classification

Based on the available information citronella nardus oil does not need to be classified for acute oral or dermal toxicity in in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).

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