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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:
23 Sep - 08 Dec 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
adopted Dec 2001
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Remarks:
SPF [Crl:CD(SD)]
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Atsugi Breeding Center, Charles River Laboratories Japan Inc, Japan
- Age at study initiation: 8 weeks
- Weight at study initiation: 197 - 203 g (range)
- Fasting period before study: Yes, approximately 18 h overnight
- Housing: 2 or 3 animals per cage were housed in plastic solid-floored cages (W 440 x D 275 x H 180 mm; by Hanyu Seimitsu Inc.) with bedding (ALPHA-dri, Shepherd Specialty Papers, Inc., Lot Nos: 04116 and 05116).
- Diet: CR -LPF pelleted diet (irradiation-sterilized, Oriental Yeast Co., Ltd., Lot No.: 160621), ad libitum
- Water: Tap water, ad libitum
- Acclimation period: Animals were quarantined/acclimated to the test environment for over a week at the testing facility.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 - 24
- Humidity (%): 39 - 48
- Air changes (per hr): 10 -15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 23 Sep 2016 To: 08 Dec 2016

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle: 10 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Since the acute oral toxicity of the test substance was expected to be low, the starting dose level was set at 2000 mg/kg bw.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3 (first and second step, respectively)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed frequently for the first 6 hours after administration (from immediately after administration to 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours and 6 hours after administration), and once daily thereafter for 14 days, for clinical signs such as abnormalities of external appearance, nutritional condition, posture, behavior and excretions. Body weight was recorded on day 0 of administration and on days 1, 3, 7 and 14 after administration.
- Necropsy of survivors performed: Yes, all animals were sacrificed after the 14-day observation period by exsanguination via the abdominal aorta under isoflurane anesthesia and necropsied. External appearance and organs/tissues in the cranial, thoracic and abdominal cavities were examined macroscopically.
Statistics:
For body weight, the mean value with standard deviation was calculated for each point measured for each dose step. The body weight gain during the observation period from day 0 of administration to day 14 after administration was determined and the mean value with standard deviation was calculated in the same manner.

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study period.
Clinical signs:
No clinical signs of toxicity were observed up to the end of the 14-day observation period.
Body weight:
No effect on body weight was noted.
Gross pathology:
Necropsy revealed no substance-related findings.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008