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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
25 Sept-16 Oct 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study is in accordance with GLP, according to OECD Guidelines No 420 "Acute Oral Toxicity - Fixed Dose Method" and (EC) 440/2008 No. B1 bis Acute Toxicity (Oral).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
no

Test material

Constituent 1
Reference substance name:
Cassia Oil
IUPAC Name:
Cassia Oil
Details on test material:
- Name of test material (as cited in study report): Cassia oil
- Physical state: liquid
- Storage condition of test material: room temperature in the dark

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: RccHan(TM):WIST (Harlan Laboratories, UK)
- Age at study initiation: 8-12 weeks, nulliparous and non-pregnant
- Weight at study initiation: 137-165 g
- Fasting period before study: overnight
- Housing:groups of four in suspended solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum, 2014C Teklad Global Rodent diet (Harlan Laboratories, UK)
- Acclimation period: al least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25°C
- Humidity (%): 30-70%
- Air changes (per hr): al least 15 per hour
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 1.91 ml/kg bw.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 females (of which 1 animal was tested in the sighting study)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical observations were made 0.5, 1, 2 and 4 hours after dosing, and subsequently once a day for up to 14 days. Morbidity checks were made twice a day. Bodyweights were recorded on day 0, 7, 14 or at death.
- All surviving animals were killed humanely and subjected to gross necroscopy.

Results and discussion

Preliminary study:
yes, one female at 2000 mg/kg bw
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 1/5 animals died during test
Mortality:
One animal was found dead one day after dosing in the main study. In the sighting study with one animal no mortality was observed.
Clinical signs:
Signs of systemic toxicity noted four hours after dosing in the initial treated animal were ataxia, hunched posture and pilo-erection. There were no signs of systemic toxicity noted in the remaining animals.
Body weight:
Surviving animals showed expected gains in bodyweight over the observed period.
Gross pathology:
Abnormalities noted at necropsy of the animal that died during the study were dark liver, dark kidney, gaseous stomach and pale gastric mucosa. No abnormalities were noted at necropsy of animals that were killed at the end of the study.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bw.
Therefore, the substance does not need to be classified as acute toxic via the oral route based on the criteria as outlined in 1272/2008/EC (CLP).
Executive summary:

An acute oral toxicity study - fixed dose method - was performed with five female Wistar strain rats. Study was performed according to guidelines OECD No. 420 and EC 440/2008 No. B1 bis. Following a sighting test at a dose level of 2000 mg/kg bw, an additional four fasted animals were given a single dose of test item at a dose level of 2000 mg/kg bw. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy. One animals was found dead one day after dosing in the main study. Signs of systemic toxicity noted in the initial treated animal were ataxia, hunched posture and pilo-erection. There were no signs of toxicity in the remaining animals tested in the main study. Surviving animals showed expected gains in bodyweight over the observation period. Abnormalities noted at necropsy of the animal that died during the study were dark liver, dark kidney, gaseous stomach and pale gastric mucosa. No abnormalities were noted at necropsy of animals that were killed at the end of the study. The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bw under the conditions of this test. Therefore, the substance does not need to be classified as acute toxic via the oral route based on the criteria as outlined in 1272/2008/EC (CLP).