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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

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:
Cymbopogon nardus, ext.
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:
Diuresis, morbidity, pilo erection, prostration, coma
Body weight:
no data
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.

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