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Diss Factsheets

Administrative data

Description of key information

LD50 > 2000 mg/kg bw

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: TECAM Animal Facility (S. Roque, SP).
- Age at study initiation: 9 weeks
- Weight range at study initiation: not greater than 20 percent of the mean weight
- Housing: Animals were housed using conventional polypropilene rodent cages (Beiramar, CXBHG, 4 1 X 34 X 16cm) with three animals per cage.
- Diet (e.g. ad libitum): Pelleted commercial diet for the species (Biobase Biotec) was provided ad libitum
- Water (e.g. ad libitum): Filtered water was provided ad libitum.
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23
- Humidity (%): 64 (average)
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
Test substance was applied diluted in corn oil (dilution concentration was 500 mg/mL).
Doses:
2000 mg/kg bw/day
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: Animals were observed individually after dosing during the first 24 hours with special attention given during the first 4 hours (day 1). Daily thereafter.
- Frequency of weighing: before substance administration. weekly thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
no mortality
Clinical signs:
no signs of evident toxicity
Body weight:
body weight changes within the range of physiological variability.
Gross pathology:
No macroscopic changes were observed in any of the major organs of the examined animals.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Based on the data available, the classification criteria according to Regulation (EC) 1272/2008 (CLP) are not met. Therefore, non-classification is warranted.