Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2009-06-16 to 2009-06-30
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
Batch No.: 20090226
Purity: 99.38%

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Orient Bio Ltd, 143-1 Sangdaewon-dong, Jungwun-Gu, Seoungnam-Si, Gyeonggi-Do, South Korea
- Age at study initiation: 7-8 wks
- Weight at study initiation: 179.1 to 227.5 g
- Fasting period before study: Yes, overnight
- Housing: 3-4 animals per stainless steel wire cage (255 width x 465 mm length x 200 mm height)
- Diet: Ad libitum pellet chow
- Water: Ad libitum
- Acclimation period: 5-15 d

ENVIRONMENTAL CONDITIONS
- Temperature: 19~25 °C
- Humidity: 30~70 %
- Air changes: 10~20 per hr
- Photoperiod: 12 hrs dark / 12 hrs light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Amount of vehicle (if gavage): 10 mL

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: 300 mg/kg bw as recommended by OECD Guideline 423, with the next dose determined as per the flow chart in the guidance following a 2 d observation period after treatment.

Doses:
300 mg/kg bw, 2000 mg/kg bw
No. of animals per sex per dose:
6 females per dose (0 males)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations on days 0, 1, 3, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross findings.

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
Liquid faeces in 1/6 rats at 300 mg/kg bw dose level 1 hr after dosing; soft faeces in 2/6 rats at 2000 mg/kg bw dose level 1 hr after dosing. These were considered to be due to chance, rather than be associated with the test item because they occurred at a low incidence.
Body weight:
No treatment-related effects (for full results please refer to attached supporting information).
Gross pathology:
No treatment-related effects.

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Conclusions:
The test substance was assessed for acute oral toxicity according to OECD Guideline 423. The LD50 of the test material, DEHCH was >2,000 mg/kg bw in female rats. The substance is therefore not classified.