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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000-2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

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
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
GLP compliance:
yes
Remarks:
Experimental Toxicology and Ecology, BASF Aktiengesellschaft, 67056 Ludwigshafen/Rhein, Germany
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2,3-Dihydro-1,3-dioxo-1H-perylo[3,4-cd]pyridine-8,9-dicarboxylic acid potassim salt (1:2)
EC Number:
807-752-6
Cas Number:
1451734-05-6
Molecular formula:
C24H9NO6K2
IUPAC Name:
2,3-Dihydro-1,3-dioxo-1H-perylo[3,4-cd]pyridine-8,9-dicarboxylic acid potassim salt (1:2)
Details on test material:
It cannot be entirely excluded that the test material used was the mono potassium salt rather than the di potassium salt.
Specific details on test material used for the study:
It cannot be entirely excluded that the test material used was the mono potassium salt rather than the di potassium salt. However, based on the very similar properties of these compounds, the toxicological data presented is considered valid and suitable to describe the toxicological property of the di potassium salt even if generated with the mono salt.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Deutschland, Sandhofer Weg 7, 97633 Sulzfeld
- Age at study initiation: male animals approx. 8-12 weeks, female animals approx. 10 -18 weeks
- Mean body weights at study initiation: 159g (f), 178g (m)
- Fasting period before study: at least 16 hours
- Housing: Single housing in stainless steel wire mesh cages, type DK-III (Becker & Co., Castrop-Rauxel, GER)
- Diet: Kliba-Labordiat, Provimi Kliba SA, Kaiseraugst, Switzerland, ad libitum
- Water: Tap water ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 h /12 h

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20g/100 ml
- Amount of vehicle (if gavage): 10 ml/kg
- Justification for choice of vehicle: Aqueous formulation corresponds to the physiological medium
Doses:
2,000 mg/kg
No. of animals per sex per dose:
3 male and 3 female animals
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: several times on the day of administration, at least once each workday for the individual animals. A check for any dead or moribund animal was made twice each workday and once on Saturdays, Sundays and on public holidays.
- Frequency of weighing: Individual body weights shortly before application (day 0), weekly thereafter and at the end of the study (before fasting period).
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred.
Clinical signs:
No signs of toxicity were observed during clinical examination.
Body weight:
The mean body weights of the test groups increased throughout the study period.
Gross pathology:
No macroscopic pathologic abnormalities were noted in the animals (3 males and 3 females) examined at termination of the study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study the median lethal dose of the test substance after oral administration was found to be greater than 2,000 mg/kg body weight for the male and female animals.
Executive summary:

An acute oral toxicity following OECD guideline 4223 and in compliance with GLP was performed to assess the test article's acute oral toxicity in Wistar rats. A single dose of 2000 mg/kg body weight of the test material preparation in doubly distilled water as given to six fasted animals (three males and three females) by gavage in sequential manner. No mortality occurred. No clinical signs and findings were observed. The mean body weìghts of the test groups increased throughout the study period. No macroscopic pathologic abnormalities were noted in the animals examined at the end of the observation period. Under the conditions of this study the median lethal dose of the test substance after oral administration was found to be greater than 2,000 mg/kg body weight for male and female rats.