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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

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

Administration / exposure

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

Results and discussion

Effect levels
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

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information