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Description of key information

Acute oral toxicity was greater than 2000 mg/kg. No death occured at 2000 mg/kg so no classification is required.

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:
May 20, 1999 - June 15, 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles.
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
(1996)
Deviations:
no
Qualifier:
according to guideline
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
Specific details on test material used for the study:
- Name of test material (as cited in study report): PRECYCLEMONE B
- Description: Colourless to pale yellow liquid
- Purity: 99.3%
- Batch No.: 9000320077
- Storage condition of test material: In a refrigerator (2-6°C)
- Expiration date of the batch: March 25, 2000
Species:
rat
Strain:
other: HanIbm: WIST (SPF)
Sex:
male/female
Details on test animals or test system and environmental conditions:
- Source: RCC Ltd, Biotechnology & Animal Breeding Division, CH-4414 Füllinsdorf, Switzerland
- Age at study initiation: Females: 10 weeks; Males: 8 weeks
- Weight at study initiation: Females: 180.3-188.7 g; Males: 215.5-218 g
- Fasting period before study: overnight prior to administration (16 to 18 hours)
- Housing: Group housing of 3 animals per cage in labeled Macrolon cages
- Diet: Free access to pelleted rodent diet (Kliba 3433, Provimi Kliba)
- Water: Free access to tap water
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 – 25
- Humidity (%): 40 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Details on oral exposure:
Frequency: single dosage, on Day 1.

VEHICLE
- Justification for choice of vehicle: no data
- Concentration: 0.2 g/mL

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg (10 mL/kg) body weight.

DOSAGE PREPARATION: The test substance was placed into a glass beaker on a tared Mettler balance and the vehicle was added. A weight by volume dilution was prepared using a magnetic stirrer as homogenizer. Homogeneity was maintained during treatment.
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
6 (one group of three females subsequently followed by a group of three males in a stepwise manner)
Control animals:
no
Details on study design:
- Animals were deprived of food overnight prior to dosing and until 3 hours after administration of the test substance. Water was available ad libitum.
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality/Viability: Four times during day 1 and once daily during days 2-15
Body weights: On day 1 (prior to administration), on day 8 and on day 15
Clinical signs: Four times on the day of dosing (Day 1) and once daily thereafter, until Day 15.
- Necropsy of survivors performed: yes
- Other examinations performed: none.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities occurred.
Clinical signs:
No clinical signs of toxicity occurred.
Body weight:
The bodyweight of the animals was within the range commonly recorded for this strain and age.
Gross pathology:
Macroscopic examination of the animals did not reveal any abnormalities.
Interpretation of results:
GHS criteria not met
Conclusions:
In an acute oral toxicity study with rats, conducted in accordance with OECD 423 (1996) and according to GLP principles, an oral LD50 of >2000 mg/kg was determined.
Executive summary:

The acute oral toxicity in female and male rats has been studied in accordance with OECD 423 (1996), EU Method B.1 tris (1996) and according to GLP principles. The substance was dosed in polyethylene glycol at 2 g/kg bw in 3 female and 3 male rats, in 2 steps. No mortalities and no clinical signs of toxicity occurred. Necropsy did not show any abnormality. The acute oral toxicity (LD50) was determined to be >2000 mg/kg. Based on this result, the substance does not need to be classified for acute toxicity by the oral route.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Justification for classification or non-classification