Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to OECD TG 401, EPA OPPTS 870.1100 and in accordance with the Principles of Good Laboratory Practice (GLP).
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

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
Principles of method if other than guideline:
not applicable
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: dark green cystalline solid
Details on test material:
- Name of test material (as cited in study report): 1,4,5,8-Tetra (4'-n-butylphenylamino) Anthraquinone (TBPAAQ)
- Substance type: dark green crystalline solid
- Physical state: solid
- Analytical purity: > 97% active ingredient
- Lot/batch No.: Lot #02080; TD No. 02-045
- Expiration date of the lot/batch: 31 March 2004
- Stability under test conditions: expected to be stable for the duration of testing
- Storage condition of test material: room temperature

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
- Age at study initiation: males and females: 9-10 weeks
- Weight at study initiation: males: 272 - 295 grams, females: 185 - 215 grams
- Fasting period before study: overnight fasting
- Housing: singly housed
- Diet (e.g. ad libitum): ad libitum, except during pre-dosing fasting
- Water (e.g. ad libitum): filtered tap water was supplied ad libitum by an automatic water dispensing system
- Acclimation period: 16 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 -23 °C
- Humidity (%): 29 - 51%
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Remarks:
50% w/w suspension in corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50% suspension in corn oil
- Justification for choice of vehicle: recommended vehicle by various regulatory agencies

MAXIMUM DOSE VOLUME APPLIED: 4ml/kg

Doses:
2000 mg/kg of the active ingredient present in the test substance
No. of animals per sex per dose:
5 male + 5 female/dose group
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for mortality, signs of gross toxicity, and behavioral changes at 1 and 3 hours post-dosing and at least once daily thereafter for 14 days. Individual body weights of the animals were recorded prior to test substance administration (initial) and again on Days 7 and 14 (termination).
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight and gross pathology.
Statistics:
not applicable

Results and discussion

Preliminary study:
not applicable
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
act. ingr.
Remarks on result:
other: none
Mortality:
There were no mortalities noted during the experimental period
Clinical signs:
There were no clinical signs of toxicity noted during the experimental period
Body weight:
All animals gained weight during the experimental period
Gross pathology:
No gross abnormalities were noted for the animals when necropsied at the conclusion of the 14-day observation period.
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study, the single dose acute oral LDS0 of TBPAAQ is greater than 2000 mgkg of body weight in male and female rats and hence TBPAAQ wil not be classified.
Executive summary:

An acute oral toxicity test was conducted with rats to determine the potential for TBPAAQ to produce toxicity from a single dose via the oral route. Two thousand milligrams of the active ingredient present in the test substance per kilogram of body weight was administered to ten healthy rats by oral gavage. The animals were observed for mortality, signs of gross toxicity, and behavioral changes at least once daily for 14 days. Body weights were recorded prior to administration and again on Days 7 and 14 (termination). Necropsies were performed on all animals at terminal sacrifice. All animals survived, gained weight and appeared active and healthy. There were no signs of gross toxicity, adverse pharmacologic effects or abnormal behavior. Gross necropsy findings at terminal sacrifice were unremarkable.

Under the conditions of this study, the single dose acute oral of the active ingredient in the test substance is greater than 2,000 mg/kg of body weight in male and female rats and hence TBPAAQ will not be classified.