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Toxicological information

Acute Toxicity: oral

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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: GLP Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
Cited as Directive 84/449/EEC, B.1
Deviations:
no
Principles of method if other than guideline:
The study was performed to assess the range of mortality following oral administration of the test material, applied as an emulsion in olive oil DAB 10, to wistar rats. The study was based on the EEC guideline and modified according to the acute toxic class method (Acute toxic class method (ATC Method) by E. Schlede et al: A national validation study of the acute-toxic-class method - an alternative to the LD50 test. Arch. Toxicol. 66: 455-470 (1992)).
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Laromer PO 33 F,
- Physical state: liquide, slight yellow
- Analytical purity: no data available
- Lot/batch No.: P.28/93
- Stability under test conditions: the stability of the test substance over the study period has been proven by reanalyses, stability of the test substance mixture with the vehicle has not been determined analytically
- Storage condition of test material: room temperature, exclusion of light
- other: substance number: 92/246

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
- Source: Dr. K. Thomae GmbH, 7950 Biberach
- Age at study initiation: not spezified (young adult animals)
- Weight at study initiation: mean body weigt of three male animals: 183 g; mean body weight of three female animals: 180 g
- Fasting period before study: no feed at least 16 hrs before administration, but water was available ad libitum
- Housing: single housing
- Diet: Kliba diet 343, ad libitum
- Water: tap water ad libitum
- Acclimation period: at least one week


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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: olive oil with DAB 10
Details on oral exposure:
VEHICLE
- Concentration in vehicle: not spezified
- Amount of vehicle (if gavage): not spezified
- Justification for choice of vehicle: test substance is insoluble in aqua bidest

MAXIMUM DOSE VOLUME APPLIED: 5 ml/kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
-Duration of observation period following administration: 14 days
-Frequency of observation and weighing: animals were checked for mortality twice each workday and once on saturday, sunday and on public holidays for general observations and for any dead or moribund animals. Weighing was performed before application (day 0), weekly thereafter and at the end of the study. Recording of toxicological signs and symptons several times on the day of administration, at least once each workday for the individual animals
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and symptons, body weight, general observations and mortality, pathology
Statistics:
not mentioned

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
no mortality occured
Clinical signs:
no abnormalities occured
Body weight:
DAY 7
- Males: 266 g (mean weight of 3 rats)
- Females: 209 g (mean weight of 3 rats)

DAY 13:
- Males: 309 g (mean weight of 3 rats)
- Females: 215 g (mean weight of 3 rats)
Gross pathology:
Necropsy at the end of the study revealed no abnormalities.

Any other information on results incl. tables

Body weight gain during study meets expectations.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information