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:
other: Acute oral toxicity was determined according to OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Albino Rats (Rattus norvegicus)
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
-Source: Harlan, Indianapolis, IN.
-Age: at least 49 daysold (adult)
-Weight: 202.3 - 224.2 grams
-Fasting period before study: food was withheld from the animals the night prior to dosing.
-Housing: single housing, cages: polycarbonate, bedding: hardwood chips.
-Diet: TEK 7012 Rodent diet, Harlan teklad, Madison, WI, ad libitum
-Water: tap water, ad libitum
-Acclimation period: minimum 5 days under the same conditions as for the test.

ENVIRONMENTAL CONDITIONS
-Temperature: 68°F
-Humidity: 30-70%
-Air changes: 10 to 15 per hr
-Photoperiod: 12 hrs dark/light cycle, full spectrum fluorescent lights.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Albino rats were used in this study because they have historically been used for acute oral toxicity studies and the guidelines have no alternative (non-animal) methods. The number of animals used was recommended by the OECD guidelines. Oral administration corresponds to a likely route of human exposure. The test was based on a stepwise procedure with the use of a minimum number of animals per step, enabling sufficient information to be obtained on the acute toxicity of the test substance.
Doses:
The test substance was a powder and formulated as a suspension using water.
A limit test was carried out at 2000mg/Kg body weight.
All animals dosed at 2000 died before the end of the study. According to OECD, the subsequent dose was reduced to 300mg/Kg.
No. of animals per sex per dose:
3 animals for 2000mg/Kg (female)
6 animals for 300mg/Kg (female)
Control animals:
no
Details on study design:
-Duration of observation period following administration: 14 days.
-Frequency of observations and weighing: at day 0, day 7 and day 14.
-Necropsy of survivors performed: yes.
-Other examinations performed: clinical signs and body weight.

Results and discussion

Preliminary study:
All animals dosed at 2000 died before the end of the study. According to OECD, the subsequent dose was reduced to 300mg/Kg.
Effect levels
Sex:
female
Dose descriptor:
LDLo
Effect level:
> 300 mg/kg bw
Mortality:
At 300mg/Kg:
All animals survived the duration of the study (14 days).
Clinical signs:
At 300mg/Kg:
No clinical manifestations of toxicity were observed in any of the animals at this dose for the duration of the in-life phase.
Body weight:
At 300mg/Kg:
All animals at this dose gained weight by the end of the study.
Gross pathology:
No unusual findings were found during necropsy in all animals dosed at 300mg/Kg.

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
The test substance as defined under the GHS for the classification of chemicals falls under Category 4, >300-2000.