Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August 1-15, 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study has been performed according to OECD guideline 401 and meets the requirements of GLP. The fasting period was longer than prescribed in OECD guideline 401 (19.5 hours instead of overnight), however, this is considered a worst-case condition and does not influence the reliability.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: dark blue powder
- Stability under test conditions: expected to be stable

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ace Animals, Inc., Boyertown, PA, USA
- Age at study initiation: young adults (8-9 weeks)
- Weight at study initiation: males: 185-206 g; females: 161-185 g
- Fasting period before study: 19.5 hours
- Housing: singly housed
- Diet (e.g. ad libitum): Purina Rodent Chow #5012
- Water (e.g. ad libitum): Filtered tap water ad libitum
- Acclimation period: 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 26
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 /12


IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 30% w/w
- Amount of vehicle (if gavage): 17.02 ml/kg, so administration in 2 portions, 3 hours apart.

DOSAGE PREPARATION (if unusual):
Prior to use, the test sample was ground in a coffee mill. The ground sample was mixed with corn oil, then heated to 70 ºC and administered at room temperature.

Doses:
5,000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1, 2, 3, 5 hours post-dosing and each days thereafter; body weight prior to test substance administration and on days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: behavioural changes.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No mortality occurred.
Clinical signs:
All animals appeared active and healthy.
Body weight:
All animals gained weight.
Gross pathology:
No gross abnormalities were noted for the animals when necropsied at the conclusion of the 14-day observation period.
Other findings:
Apart from blue feces noted for all rats between days 1 and 4, there were no other signs of gross toxicity, adverse pharmacologic effects or abnormal behaviour.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the condition of this study, the single dose acute oral LD50 of the test substance is > 5000 mg/kg bw in male and female rats.