Registration Dossier

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:
no

Test material

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

Test animals

Species:
rat
Strain:
other: Crl:CD(SD)
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 10 or 11 weeks
- Weight at study initiation: 194.8-224.7 g
- Fasting period before study: yes; 16-18.5 hours prior to dosing
- Housing: singly in stainless steel, wire-mesh cages that contained enrichment (e.g., nestlet or nylabone).
- 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: at least 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-26 °C
- Humidity (%): 30-70%
- 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 (Dose volume: 0.159, 0.5, 1.59, 4.545 mL/kg)
No. of animals per sex per dose:
Single dose to 1 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 dosed 1 at a time at a minimum of 48-hour intervals.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: at the beginning of fasting, just before dosing (test day 0), once during the first 30 minutes after dosing and 2 more times on the day of dosing, and once each day thereafter.
-Frequency of weighing: on test days –1, 0, 7, and 14
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No deaths occurred.
Clinical signs:
One of the rats dosed at 5000 mg/kg exhibited high posture on the day of dosing. No other clinical signs were observed.
Body weight:
No body weight losses occurred in the rats after dosing.
Gross pathology:
No gross lesions were present in the rats at necropsy.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
LD50 (female rats) > 5000 mg/kg
Executive summary:

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 dosed 1 at a time at a minimum of 48 hour intervals. 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. One of the rats dosed at 5000 mg/kg exhibited high posture on the day of dosing. No other clinical signs were observed. The rats exhibited no body weight losses after dosing. No gross lesions were present in the rats at necropsy. Under the conditions of this study, the oral LD50 for the test substance was greater than 5000 mg/kg for female rats.