Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Qualifier:
according to
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

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: Solid (powder) / red-brown
- Analytical purity: active ingredients: 79 g/100 g (1 H-NMR)
- Storage condition of test material: Room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Deutschland, Sandhofer Weg 7, 97633 Sulzfeld
- Age at study initiation: male animals approx. 8 - 16 weeks, female animals approx. 9 - 16 weeks
- Mean body weights at study initiation: 167g (f), 188g (m)
- Fasting period before study: at least 16 hours
- Housing: Single housing in stainless steel wire mesh cages, type DK-1l1 (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:
other: 0.5% Tylose CB 30.000 (cleaned sod iumcarboxymethylcellulose, Hoechst AG)
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:
Male animal symptoms: No signs of toxicity were observed during clinical examination for male animals. In female animal, signs of toxicity noted in the 2,000 mg/kg dose group comprised impaired and poor general state, dyspnoea, apathy, staggering, ataxia and piloerection were observed from 2 hours after application until including study day 3.
Body weight:
The animals gained weight throughout the study period.
Gross pathology:
No gross pathological abnormalities were noted in the animals (3 males and 3 females) necropsied at the end of the study.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
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 0.5 % Tylose CB 30.000 in Aqua bidest. was given to six fasted animals (three males and three females) by gavage in sequential manner. No mortality occurred. No signs of toxicity were observed in the male animals. Signs of toxicity noted in the 2,000 mg/kg dose group in the female animals comprised impaired and poor general state, dyspnoea, apathy, staggering, ataxia and piloerection. Findings were observed from 2 hours after application until including study day 3. The animals gained weight throughout the study period. No abnormalities were noted at necropsy of the animals at the end of the study. Under the conditions of this study the median lethal dose of the test substance after oral application was found to be greater than 2000 mg/kg body weight for the male and female animals.