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Administrative data

Description of key information

In the acute oral toxicity study no death occurred up to the highest dose administered which amounted to 10000 mg/kg body weight.

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was conducted in a contract research organization according to internationally accepted technical guidelines then at force, but without QA-statement. The study is scientifically valid and, despite limited documentation, fully adequate for assessment.
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Strain Winkelmann, Paderborn
- Age at study initiation: no data
- Weight at study initiation: 180 - 190 g
- Fasting period before study: 16 hours
- Housing: in groups of 5 males or 5 females
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 1°C
- Humidity (%): 45% - 55%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 h / 1 2h
Route of administration:
oral: gavage
Vehicle:
other: 1% Tylose (cellulose ether)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: low dose: 25%, mid dose and high dose : 30%
- Amount of vehicle (if gavage):low dose: 10 ml/kg, mid dose: 17 ml/kg, high dose : 33 m l/kg

Doses:
2500, 5000, and 10000 mg/kg body weight
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations 1, 2, 7, and 14 days after application, weighing at start and on day 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs: appearance, behaviour, hair coat, mucosae, faeces, food and water intake
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Mortality:
no death occurred
Clinical signs:
there were no clinical signs in any animal
Body weight:
no differences in body weight gain between animals of the three dose groups
Gross pathology:
no findings in any animal in lungs, heart, stomach, small and large intestine, liver, spleen, kidneys, blood vessels, lymphatic vessels, reproductive glands
Interpretation of results:
practically nontoxic
Remarks:
Migrated information
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

The acute oral toxicity study demonstrated that the LD50 of WS400505 is higher than the limit dose of 2000 mg/kg b.w. The conduct of an acute dermal or inhalation toxicity study would not have added relevant toxicological hazard information

Justification for classification or non-classification

In the acute oral toxicity study, all animals survived a single dose of up to 10000 mg WS400505 per kg body weight. Therefore, classification of WS400505 for acute oral toxicity is not required [REGULATION (EC) 1272/2008].

Non-classification of WS400505 by the dermal route was reasonable, because of the absence of effects indicative of relevant systemic toxicity and/or local irritation and the absence of any relevant adverse effects in all available toxicity studies with WS400505.

 

Non-classification of WS400505 by the inhalation route was justified by its low vapour pressure making inhalation exposure of humans to any vapour phase unlikely.