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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
29 August - 19 September 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted in GLP compliance and in accordance with several internationally achnowledged guidelines for the testing of chemicals.

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
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Chlorobenzoylacetonitril
IUPAC Name:
Chlorobenzoylacetonitril
Test material form:
other: solid
Details on test material:
Name: Chlorobenzoylacetoniril
Batch No. 46
Physical state: solid
Colour: yellow
Molecular weight: 179.61 g/mol
Purity: > 99%
Storage: in original container at 4°C

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen
- Weight at study initiation: male: 174-226g, female: 174-189g.
- Housing: kept in Matrolon cages on Altromin saw fiber beddings
- Diet (e.g. ad libitum): ad libitum diets for rats and rabbits
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: adequate
- Fasting: overnight prior to start of test

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 3°C
- Humidity (%): 55% +/- 10%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12:12 hrs

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
DMSO
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2000 mg test item were mixed in DMSO ad 4 mL.
- Amount of vehicle (if gavage): 4mL
- Justification for choice of vehicle: non-toxic characteristics of vehicle
- Lot/batch no.: 401105/1 32499



MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bodyweight


Doses:
single dose
- Concentration in vehicle: 2000 mg test item were mixed in DMSO ad 4 mL.
- Amount of vehicle (if gavage): 4mL
- Justification for choice of vehicle: non-toxic characteristics of vehicle
- Lot/batch no.: 401105/1 32499



MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bodyweight

No. of animals per sex per dose:
3 per sex
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: prior to first application and once a week after
- Necropsy of survivors performed: yes (gross pathology)
- Other examinations performed: cage side observations were made on a daily base

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
none
Clinical signs:
Some clinical signs of toxicity were observed throughout the observation period. Beside a reduced spontaneous activity for the first five days, all animals showed tiredness up to lethargy for the first two days after application.
Body weight:
At day 7 weight loss was recorded in all female animals and one male animal, which they all regained within the 2nd week of observation. However, at day 14 these animals' weight range was still out of the expected range.
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral toxicity LD50 of the test substance in rats was determined to be > 2000 mg/kg bw.