Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
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 or test system 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.