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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:
From April 19th to May 3rd, 1973.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Principles of method if other than guideline:
- Procedure found in Section 191.1 (f)(1) of the Federal Hazardous Substance Act; NPI Standard Test No.6.
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
TEST MATERIAL
- Lot No. 6-RS-7, received April 5, 1973.
- Purity (HPLC): 98.5%

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 234g (females) and 290g (males).
- Fasting period before study: overnight
- Diet: commercial laboratory animal feed ad libitum.
- Water: bottled spring water ad libitum.
- Acclimation period: 6d.

IN-LIFE DATES: From: April 19, 1973 To: May 3, 1973.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: The test material was used in a 12.5% gravimetric suspension in water.
- Amount of vehicle (if gavage):

MAXIMUM DOSE VOLUME APPLIED:

DOSAGE PREPARATION: the powdered neohesperidin dihydrochalcone was mixed with 8cc of distilled water and allowed to stand 15min prior to being administered to animals. Females received 1.2g and males 1.5g test item each.
Doses:
5000 mg/kg bw.
No. of animals per sex per dose:
5 per sex per dose
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for signs of pharmacologic activity and drug toxicity at 1, 3, 6 and 24h post-dosage. Observations were made daily thereafter to a total of 14d.
- Necropsy of survivors performed: yes. Animals sacrificed at the end of the 14-day observation period were subjected to complete gross necropsy.
- Other examinations performed: clinical signs, body weight, histopathology.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
All animals were alive at the completion of the test.
Clinical signs:
No effects observed.
Body weight:
No effects observed.
Gross pathology:
No gross changes observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
EU criteria
Conclusions:
Based on read-across approach, the target substance was found to be non toxic, LD50 ≥ 5000mg/kg.
Executive summary:

The acute oral toxicity of neohesperidin dihydrochalcone on rats was studied by a method similar to OECD TG 420. A limit test was performed by administering a single dose of 5g/kg bw test item to 10 (5M/5F) Wistar rats, and observing the effects for 14 days (clinical signs, body weights). No effects were observed in any animal. Therefore, the test item was found to be non toxic, with an LD50 > 5000 mg/kg bw.