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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
27-11-2004 to 15-12-2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study performed under GLP. All relevant validity criteria were met.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

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:
equivalent or similar to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
inspected: December 2002 ; signature: February 2003
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
451-230-7
EC Name:
-
Cas Number:
55739-89-4
Molecular formula:
C10H18O
IUPAC Name:
2-ethyl-4,4-dimethylcyclohexan-1-one
Test material form:
liquid
Details on test material:
- Physical state: Liquid
- Storage condition of test material: approximately 4 ºC in the dark, under nitrogen
- Other: clear colourless

Test animals

Species:
rat
Strain:
Sprague-Dawley
Remarks:
Crl: CD (SD) IGS BR
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Recognised animal supplier
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 207 - 242 g
- Fasting period before study: Overnight
- Housing: The animals were housed in 3 per cage suspended solid-floor polypropylene cages furnished with woodflakes
- Water: ad libitum
- Acclimation period: Five (5) days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25 (controlled)
- Humidity (%): 30-70 (controlled)
- Air changes (per hr): 15/hour
- Photoperiod (hrs dark / hrs light): 12 hours light/dark

IN-LIFE DATES: From: 27-11-2003 To: 02-12-2003

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: Not applicable.
- Amount of vehicle (if gavage): Not applicable.
- Justification for choice of vehicle: Not applicable.
- Lot/batch no. (if required): Not applicable.
- Purity: Not applicable.

MAXIMUM DOSE VOLUME APPLIED: 2.22 mL/kg

DOSAGE PREPARATION (if unusual): Not applicable.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: In the absence of data suggesting the test item was toxic, 2000 mg/kg was chosen as the starting dose.
Doses:
2000 mg/kg
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: prior to and then 0.5, 1, 2, 4 hours after dosing; once daily. Individual bodyweights prior to and at 7 and 14 days after treatment.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities.
Clinical signs:
Hunched posture, lethargy and ataxia were noted in three of six females during the day of dosing and up to 24 hours after dosing. All signs ceased by 48 hours. Three of six animals appeared normal throughout the study period.
Body weight:
All females showed expected gains in bodyweight over the study period.
Gross pathology:
No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study, the test item oral median LD50 was estimated to be greater than 2500 mg/kg bw in female Sprague-Dawley CD strain rats.
Executive summary:

The study was performed according to OECD 423 and EU Method B1 tris Acute Toxicity and according to GLP to assess the acute oral toxicity of the test item following a single oral administration in the Sprague-Dawley CD strain rat by the acute class method. A group of three fasted females was treated with the test item at a dose level of 2000 mg/kg bodyweight. This was followed by a further group of three fasted females at the same dose level. The test item was administered orally undiluted. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy. There were no mortalities. Hunched posture, lethargy and ataxia were noted in three of six females during the day of dosing and up to 24 hours after dosing. All signs ceased by 48 hours. Three of six animals appeared normal throughout the study period. All females showed expected gains in bodyweight over the study period. No abnormalities were noted at necropsy. The acute oral median lethal dose (LD50) of the test item in the female Sprague-Dawley CD strain rat was estimated to be greater than 2500 mg/kg bw. Applicant assessment indicates: under the conditions of this study the acute toxicity estimate could be considered to be > 5000 mg/kg bw.