Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008-05-19 to 2008-06-18
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
signed 2007-04-20
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Naringin DHC; 1-[4-[[2-O-(6-Deoxy-L-mannopyranosyl)-D-glucopyranosyl]oxy]-2,6-dihdroxyphenyl]-3(4-hydroxyphenyl)-1-propanone
- Substance type: technical product
- Physical state: solid, whitish powder
- Analytical purity: 99 % [a/a]
- water content: 6.4 %
- Lot/batch No.: 2
- Expiration date of the lot/batch: January 2010
- Storage condition of test material: 15-25 °C, dark, don't freeze, keep away from strong light and heat

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, 97633 Sulzfeld, Germany
- Age at study initiation: 49-51 days
- Weight at study initiation: 161-182 g
- Fasting period before study: approx. 16 hours before administration
- Housing: granulated wood as bedding material, cages cleaned twice a week; during observation period, the animals were kept single in MAKROLON cages (Type III)
- Diet: commercial diet, ssniff R/M-H V1534
- Water (ad libitum): tap water
- Acclimation period: 5 adaptation days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 °C +/- 3 °C
- Humidity (%): 55 % +/- 15%
- Photoperiod (hrs dark / hrs light): 12/12

- no further significant details stated

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: aqueous hydroxypropylmethylcellulose
Details on oral exposure:
VEHICLE
- Concentration in vehicle: The test item was suspended in 0.8 % Methocel Solution
- Administration Volume: 10 mL/kg bw
- Lot/batch no. (if required): 07D04-N12
Doses:
1 dose level group: 2000 mg/kg bw (limit test)
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: before and immediately, 5, 15, 30 and 60 minutes, as well as 3, 6 and 24 hours after administration
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs,organ weights, histopathology, other (at least once a working day): changes of skin and fur, eyes and mucous membranes, respiratory and the circulatory, autonomic and central nervous systemand somatomotor activity, as well as behaviour pattern. Attention was paid to possible tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
- observation for mortality: once daily
- body weights: before administration and thereafter weekly
- no further significant details stated

Results and discussion

Preliminary study:
not applicable
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
no
Clinical signs:
no
Body weight:
all animals gained the expected body weight
Gross pathology:
no findings
Other findings:
no significant data

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information one study used for classification Criteria used for interpretation of results: EU
Conclusions:
A single oral administration of 2000 mg Narigin dihydrochalone (DHC)/kg b.w. to rats did not reveal any signs of toxicity. No mortality occured. All animals gained the expected body weight. No pathological changes were observed at necropsy findings. Hence, the substance has not to be classified at this time accroding to CLP.