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Administrative data

Description of key information

Oral rat: LD50 > 2000 mg/kg bw  (no mortality at 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:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS: rats, Wistar Crl:(WI) BR (outbred, SPF-Quality)
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: ca. 7 weeks
- Housing: group housing of 3 animals per sex per cage (Macrolon cages, type IV)
- Fasting period before study: up to 20h prior to dosing, 3-4h after administration of the test material
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3
- Humidity (%): 30-70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:
oral: gavage
Vehicle:
propylene glycol
Details on oral exposure:
VEHICLE
- Amount of vehicle (if gavage): 10 ml/kg bw
- Justification for choice of vehicle: the vehicle was tested in a pre-test.
Doses:
single dose: 2000 mg/kg bw
No. of animals per sex per dose:
3 animals/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: twice daily (mortality//viability), at periodic intervals on Day 1 (administration) and thereafter once daily until Day 15 (clinical signs)
- Frequency of weighing: Days 1 (pre-administration), 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology
Statistics:
not performed
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occured.
Clinical signs:
Lethargy, hunched posture, uncoordinated movements and/or piloerection were noted among the females on Day 1. No clinical signs of systemic toxicity were noted in males.
Body weight:
The mean body weight gain shown by the surviving animals over the study period was considered to be similar to that expexted of normal untreated animals of the same age and strain.
Gross pathology:
No abnormalities were found at macroscopic post mortem examination of the animals.
Interpretation of results:
other: no acute lethal toxicity
Conclusions:
Based on the results and according to the EU REGULATION (EC) 1272/2008 the substance does not have to be classified for oral toxicity.
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

Oral rat: LD50 > 2000 mg/kg bw (no mortality at 2000 mg/kg bw). Acute dermal rat: Waiving, as this study was considered to be scientifically unjustified. Acute inhalation rat: Waiving, as this study was considered to be scientifically unjustified. Exposure to WS400102 by the inhalation route is unlikely, because of its low vapour pressure and because it is a highly viscous liquid.

Justification for classification or non-classification

In the acute oral toxicity study in rats no death occurred at the highest dose of 2000 mg/kg bw. Systemic exposure to WS400102 after dermal or inhalation exposure will be much lower than after oral exposure and therefore no higher toxicity is to be expected via these exposure routes. No requirement of classification for acute oral, dermal or inhalation toxicity [Regulation (EC) 1272/2008].