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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:
other: This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

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:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Purity: 97.59%

Test animals

Species:
rat
Strain:
other: Rat/Sprague-Dawley derived, albino
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: Young adult (9-11 weeks)
- Weight at study initiation: 169-224 grams
- Fasting period before study: overnight
- Housing: singly in suspended stainless steel caging. Litter paper was placed beneath the cage and was changed at least three times per week.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum, Purina Rodent Chow #5012
- Acclimation period: 7-24 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22°C
- Humidity (%): 44-66%
- 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:
The test substance was administered using a stainless steel ball-tipped gavage needle attached to an appropriate syringe. Following administration, each animal was returned to its designated cage. Feed was replaced approximately 3-4 hours after dosing.
Doses:
175, 550, 1750, 5000 mg/kg
No. of animals per sex per dose:
1 female per dose level at 175, 550 and 1750 mg/kg
3 females at 5000 mg/kg
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: The animals were observed 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
- Other examinations performed: The animals were observed for mortality, signs of gross toxicity, and behavioural changes. Observations included gross evaluation of skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behaviour pattern.
- Females were selected for the test because they are frequently more sensitive to the toxicity of test compounds than males.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Remarks on result:
other: No deaths. Ano-genital staining in one 5000 mg/kg animal. Otherwise, no clinical signs, body weight effects, or gross necropsy findings.
Mortality:
None
Clinical signs:
Ano-genital staining observed in one 5000 mg/kg rat between 3 and 5.5 hours post-dosing. Otherwise, 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 animals when necropsied.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: Directive 67/548/EEC, Globally Harmonized System (GHS)
Conclusions:
LD50 > 5000 mg/kg of body weight in female rats
The study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).
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. Based on a limit dose of 5000 mg/kg, a Main Test was conducted using a default starting dose level of 175 mg/kg administered to one healthy female rat by oral gavage. Following the Up and Down procedure, five additional females were tested at levels of 550, 1750 and 5000 mg/kg. Females were selected for the test because they are frequently more sensitive to the toxicity of test compounds than males. All animals were observed for mortality, signs of gross toxicity, and behavioural changes at least once daily for 14 days after dosing. Body weights were recorded prior to administration and again on Days 7 and 14 (termination) following dosing. Necropsies were performed on all animals at terminal sacrifice. All animals gained body weight during the study. Ano-genital staining observed in one 5000 mg/kg rat between 3 and 5.5 hours post-dosing. Otherwise, there were no signs of gross toxicity, adverse pharmacologic effects, or abnormal behaviour. No gross abnormalities were noted for any of the animals when necropsied. 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.