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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:
18 May - 06 June 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
National GLP Compliance Monitoring Authority, Department of Science & Technology, New Delhi, India; Food and Consumer Product Safety Authority (VWA), The Hague, the Netherlands; Bundesinstitut für Risikobewertung, Berlin, Germany
Test type:
up-and-down procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: inhouse bred (Outbred), Toxicology, Department of Safety Assessment, Advinus Therapeutics Limited, Bangalore 560 058, India
- Age at study initiation: 10-11 weeks
- Weight at study initiation: 177.3-180.3 g (range)
- Fasting period before study: yes, overnight (16-18 hours)
- Housing: the rats were housed individually in standard polysulfone cages (approximately L 425 mm x B 266 mm x H 175 mm) with stainless steel top grill, with facilities for pelleted food and water; steam sterilised corn cob bedding was used and changed along with the cage twice weekly
- Diet: Ssniff rats/mice pellet food, manitenance meal (Ssniff Spezialdiaten GmbH, Soest, Gemany), ad libitum
- Water: deep bore-well water passed through activated charcoal filter and exposed to UV-rays in Aquaguard on-line water filter-cum-purifier (Eureka Forbes Ltd., Mumbai, India), ad libitum
- Acclimation period: 5-10 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-24
- Humidity (%): 58-68
- Air changes (per hr): 12-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 13 May 2011 To: 1, 3 and 6 June 2011

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Amount of vehicle (if gavage): 20 mL/kg bw
- Justification for choice of vehicle: the test substance forms a visibly homogenous solution in water

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw (3.5-3.6 mL absolute volume)
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
3, dosed stepwise with a 2-day interval, according to the up-and-down procedure
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the animals were observed for mortality and clinical signs 1/2, 1, 2, 3 and 4 hours after administration on Day 1, and daily thereafter throughout the study period; the animals were weighed on Day 1 (prior to administration), 8 and 15
- Necropsy of survivors performed: yes, external surfaces of the body, all orifices, tissues and organs of the thoracic and abdominal cavities were examined, and all gross findings were recorded

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
There was no mortality during the study period.
Clinical signs:
No clinical signs were observed during the study period.
Body weight:
No effect on body weight was noted.
Gross pathology:
Necropsy and histopathological examination revealed no substance-related findings.

Any other information on results incl. tables

Table 1: Mortality and clinical signs during the study period

 

Dose
[mg/kg bw]

Toxicological results*

Duration of clinical signs

Time of death

Mortality (%)

Females

5000

0/0/3

---

---

0

LD50 > 5000 mg/kg bw

                                                                                           

* first number = number of dead animals                                 

 second number = number of animals with clinical signs         

 third number = number of animals used                               

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
CLP: not classified
DSD: not classified