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:
2013
Report Date:
2013

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
Test material form:
solid: particulate/powder
Details on test material:
Purity: 92.1%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 171-177 g
- Fasting period before study: fasted overnight
- Housing: The animals were individually housed in plastic solid bottom polycarbonate cages
- Diet: Harlan Teklad Global 16% Protein Rodent Diet® #2016. The diet was available ad libitum, except during fasting.
- Water: Filtered tap water was supplied ad libitum by an automatic water dispensing system.
- Acclimation period: 6 or 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21ºC
- Humidity (%): 30-67%
- Air changes (per hr): 14
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: administered as a 45% w/w mixture in a 0.5% w/v aqueous solution of methylcellulose
Details on oral exposure:
The test substance was administered as a 45% w/w mixture in a 0.5% w/v aqueous solution of methylcellulose.
Doses:
5000 mg/kg
No. of animals per sex per dose:
3 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: The animals were observed for mortality, signs of gross toxicity, and behavioural changes during the first several hours post-dosing and at least once daily thereafter for 14 days after dosing.
-Frequency of weighing: Individual body weights of the animals were recorded prior to test substance administration (initial) and again on Days 7 and 14 (termination) following dosing.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
Apart from one female exhibiting reduced faecal volume on Day 1, there were no other signs of gross toxicity or abnormal behaviour.
Body weight:
All animals survived test substance administration and gained body weight during the study.
Gross pathology:
No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.

Applicant's summary and conclusion

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

An acute oral toxicity test (Up and Down Procedure) was conducted with rats to determine the potential for the test substance to produce toxicity from a single dose via the oral route. An initial limit dose of 5000 mg/kg was administered to one healthy female rat by oral gavage. Due to the absence of mortality in this animal, two additional females received the same dose level, simultaneously. Since these animals survived, no additional animals were tested. All animals were observed for mortality, signs of gross toxicity, and behavioural changes at least once daily for 14 days after dosing.

All animals survived test substance administration and gained body weight during the study. Apart from one female exhibiting reduced faecal volume on Day 1, there were no other signs of gross toxicity or abnormal behaviour. 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 acute oral LD50 of the test substance is greater than 5000 mg/kg of body weight in female rats.