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Administrative data

Description of key information

The acute oral toxicity in rats of the test item was determined in an OECD guideline study (BASF, 1999). The LD50 was determined to be > 2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1999-06-22 to 1999-11-23
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
1996
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
1996
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes
Test material information:
Composition 1
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Boehringer Ingelheim Pharma KG
- Age at study initiation: Young adult animals
- Weight at study initiation: Animals of comparable weight; (150g - 300g) (+/- 20% of the mean weight)
- Fasting period before study: The animals were given no feed at least 16 hours before administration, but water was available ad libitum.
- Housing: Single housing in steinless steel wire mesh cages, type DK-III, Becker & Co., Castrop-Rauxel, FRG
- Diet: Kliba-Labordiaet, Klingentalmuehle AG Kaiseraugst, Switzerland, ad libitum
- Water: Tap water ad libitum
- Acclimation period: Acclimatization for at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24 °C
- Humidity: 30 - 70 %
- Air changes: Fully air conditioned rooms
- Photoperiod: 12 / 12 (h dark / h light) (6.00 a.m.- 6.00 p.m. / 6.00 p.m. - 6.00 a. m.)
Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 40.000 g/100 mL
- Justification for choice of vehicle: Good solubility in olive oil

MAXIMUM DOSE VOLUME APPLIED: 5.00 mL/kg bw

CLASS METHOD
- Rationale for the selection of the starting dose: Based on the physical and chemical characteristics of the test substance and the composition no pronounced acute oral toxicity was expected. Therefore a dose of 2000 mg/kg bw has been chosen in a first step with 3 female animals. Because no mortality occurred, 2000 mg/kg bw have been tested in a second step with animals of the other sex (3 male rats).
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3 x female
3 x male
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals. Weighing shortly before application (day 0), weekly thereafter and at the end of the study (before fasting period). A check for any dead or moribund animal was made twice each workday and once on saturdays, sundays and on public holidays.
- Necropsy of survivors performed: Yes. Necropsy at the last day of the observation period. Withdrawal of food at least 16 hours before killing with C02; then necropsy with grosspathology examination. Necropsy of all animals that died before as early as possible.
- Other examinations performed: clinical signs, body weight, grosspathology examination
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality
Mortality:
No mortality occured in both test groups.
Clinical signs:
Number of male animals showing symptoms:
Dose (mg/kg bw): 2000
No. of animals: 3
Impaired general state: 3
Poor general state: 1
Dyspnoea: 3
Apathy: 1
Abdominal position: 3
Staggering: 3
Piloerection: 3
Smeared fur: 1

Number of female animals showing symptoms:
Dose (mg/kg bw): 2000
No. of animals: 3
Impaired general state: 3
Poor general state: 1
Dyspnoea: 3
Apathy: 1
Staggering: 3
Diarrhea: 1
Body weight:
The expected body weight gain was observed in the course of the study.
Gross pathology:
No abnormalities were noted.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
2 000 mg/kg bw
Quality of whole database:
GLP guideline study

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Oral:

The study was performed to assess the acute toxicity following oral administration of the test item, applied as a solution in olive oil, in Wistar rats. The study procedure was based on the EC and OEÇD guidelines. To a group of six fasted animals (three males and three females) a single oral dose of the test material preparation in olive oil at a dose level of 2000 mg/kg body weight was given. Signs of toxicity noted in the male and female animals comprised impaired and poor general state, dyspnoea, apathy and staggering. The male animals additionally showed abdominal position and a female rat also exhibited diarrhea. The animals appeared normal within 2 days after application. The expected body weight gain was observed in the course of the study. No mortality occurred. No abnormalities were noted at necropsy of animals sacrificed at the end of the study. Under the conditions of this study the median lethal dose of the test item after oral application was found to be greater than 2000 mg/kg body weight for the male and female animals.


Justification for selection of acute toxicity – oral endpoint
GLP and guideline study

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008 (CLP). As a result the substance is not considered to be classified for acute oral toxicity under Regulation (EC) No 1272/2008, as amended for the seventh time in Regulation (EU) No 2015/1221.