Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

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: OECD guidance study conducted under GLPs

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
up-and-down procedure

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: 9-12 weeks
- Weight at study initiation:
- Fasting period before study: overnigh (maximaum 20 hours)
- Housing: Individually housed in Macrolon cages (Mill type, height 18 cm.) containing sterilized sawdust and paper as cage enrichment.
- Diet (e.g. ad libitum): ad libitum (SM R/M-Z from SSNIFF Spezialdiaten Gmbh, Soest, Germany
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5 to 21..6
- Humidity (%): 31-80
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE
- Concentration in vehicle:175, 550, 2000 mg/kg
- Amount of vehicle (if gavage):
- Justification for choice of vehicle:
- Lot/batch no. (if required):
- Purity:

MAXIMUM DOSE VOLUME APPLIED:

DOSAGE PREPARATION (if unusual):

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Observations daily, body weights on Days 1, 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights
Statistics:
The LD50 was estimated based on the maximum likelihood by means of the AOT425StatPGM program.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
1 133 mg/kg bw
Based on:
test mat.
Mortality:
Yes, all rats at 2000 mg/kg
Clinical signs:
yes, at all dose groups
Body weight:
No effects
Gross pathology:
No macroscopic findings on rats that survived to the scheduled sacrifice. A pale, discolored liver was observed for one rat that was found dead on Day 2.
Other findings:
- Organ weights: Decreased liver weigts at 550 mg/kg, decreased spleen weights at >=550 mg/kg, decreased kidney weights at 2000 mg/kg
- Histopathology:
- Potential target organs:
- Other observations:

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 value of 2-pentanone oxime (methyl propylketoxime) in Wistar rats was estimated to be approximatley 1133 mg/kg and was found to be in the range of 300 to 2000 mg/kgbody weight.