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:
2012
Report Date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
Deviations:
no
Remarks:
The study was conducted according to guideline in effect at time of study conduct.
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
Remarks:
The study was conducted according to guideline in effect at time of study conduct.
GLP compliance:
yes
Test type:
up-and-down procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Purity: 22.82% solids in water

Test animals

Species:
rat
Strain:
other: Crl:CD(SD)
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: approximately 10 weeks
- Weight at study initiation: 208.8 - 235.3 g
- Fasting period before study: yes; 16-16.5 hours prior to dosing
- Housing: singly in polycarbonate pans that contained bedding with enrichment (i.e., Shepherd's™ Cob + PLUS™).
- Diet (e.g. ad libitum): ad libitum except for fasting period prior to dosing; food was returned to the rats approximately 3-3.5 hours after dosing
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26 °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:
5000 mg/kg (corrected for percent solids (22.82%))
No. of animals per sex per dose:
3 female rats at a dose of 5000 mg/kg. The dose for each rat was corrected for percent solids (22.82%).
Control animals:
no
Details on study design:
- One rat was initially dosed. The remaining 2 rats were simultaneously dosed 2 days later.
- 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
Based on:
other: solids
Mortality:
No deaths occurred during the 14 days after dosing.
Clinical signs:
The rats exhibited no clinical signs during the 14 days after dosing.
Body weight:
No body weight losses occurred during the 14 days after dosing.
Gross pathology:
Gross discoloration of the lungs was observed in two of three rats. This is a non-specific finding and is common in rats of this strain and age.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).
LD50 (female rats) > 5000 mg/kg, adjusted for purity (22.8% solids).
Executive summary:

A single dose of test substance was administered by oral gavage to 3 fasted female rats at a dose of 5000 mg/kg, adjusted for purity (22.8% solids). One rat was initially dosed. The remaining 2 rats were simultaneously dosed 2 days later. 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. The rats exhibited no clinical signs or body weight losses during the study.

Gross discoloration of the lungs was observed in two of three rats. This is a non-specific finding and is common in rats of this strain and age. No other gross findings were observed. Under the conditions of this study, the oral LD50 for the test substance was greater than 5000 mg/kg for female rats.