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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
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 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
Test type:
up-and-down procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Purity: not reported as such

Test animals

Species:
rat
Strain:
other: Sprague-Dawley derived, albino.
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 10-11 weeks
- Weight at study initiation: 193-219 g
- Fasting period before study: yes; overnight prior to dosing
- Housing: singly in suspended stainless steel caging with mesh floors. Litter paper was placed beneath the cage and was changed at least 3 times per week.
- Diet (e.g. ad libitum): ad libitum except for fasting period prior to dosing; food was returned to the rats approximately 3-4 hours after dosing
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 16-23 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22°C
- Humidity (%): 39-71% The humidity was above the targeted upper limit for one day during the study. A portable dehumidifier was used to decrease the humidity levels during this time.
- Air changes (per hr): Not Reported
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: Not Reported
Doses:
175, 550, 1750, 5000 mg/kg
No. of animals per sex per dose:
One female each at dose levels of 175, 550 or 1,750 mg/kg and 3 females at 5,000 mg/kg.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: All animals were observed for mortality, signs of gross toxicity, and behavioural changes approximately one hour post-dosing and during the first several hours post-dosing and at least once daily thereafter for 14 days after dosing.
-Frequency of weighing: prior to administration (initial) and again on Days 7 and 14 (termination) following dosing.
- Necropsy of survivors performed: yes, on all animals at terminal sacrifice. Tissues and organs of the thoracic and abdominal cavities were examined.
Statistics:
The Acute Oral Toxicity (Guideline 425) Statistical Program (Weststat, version 1.0, May 2001) was used for all data analyses including: dose progression selections, stopping criteria determinations and/or LD50 and confidence limit calculations.

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 other: mg/kg bw ( >1000 mg/kg based on ~20% solids content)
Mortality:
No deaths occurred.
Clinical signs:
All animals appeared active and healthy. There were no signs of gross toxicity, adverse pharmacologic effects, or abnormal behaviour.
Body weight:
All animals gained body weight during the study.
Gross pathology:
No gross abnormalities were noted for any of the rats at necropsy.

Any other information on results incl. tables

The aqueous dispersion of the test substance (~ 20% solids and ~80% water) was administered directly without correction for active ingredients since the product does not exist as solids alone and is always transported and used as the aqueous dispersion. The material was not toxic via the oral route of exposure as evidenced by the LD50 of > 5000 mg/kg. This is equivalent to an approximate LD50 of > 1000 mg a.i./kg of solids.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
LD50 (female rats) > 5000 mg/kg. This is equivalent to an approximate LD50 of > 1000 mg a.i./kg of solids.
Executive summary:

Following the Up and Down procedure, a single dose of test substance was administered by oral gavage to 1 fasted female rat each at a dose of 175, 550, or 1750 mg/kg and to 3 fasted female rats at a dose of 5000 mg/kg. The rats were observed for mortality, body weight effects, and clinical signs for 14 days after dosing. All rats were necropsied to detect grossly observable evidence of organ or tissue damage. No deaths occurred. All animals appeared active and healthy and gained weight over the 14-day observation period. No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period. Under the conditions of this study, the oral LD50 for the test substance is greater than 5000 mg/kg for female rats.