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Diss Factsheets

Administrative data

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
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May 20, 1999 - June 15, 1999
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.
according to guideline
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
according to guideline
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
GLP compliance:
Test type:
acute toxic class method
Limit test:
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
other: HanIbm: WIST (SPF)
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

- 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
polyethylene glycol
Details on oral exposure:
Frequency: single dosage, on Day 1.

- 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.
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:
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
Dose descriptor:
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
No mortalities occurred.
Clinical signs:
other: No clinical signs of toxicity occurred.
Gross pathology:
Macroscopic examination of the animals did not reveal any abnormalities.
Interpretation of results:
GHS criteria not met
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:
2 000 mg/kg bw

Additional information

Justification for classification or non-classification