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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 an oral acute study no mortality was recorded at a dose of 15000 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
Study period:
1967
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: early study; summary; no GLP;
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
no
Remarks:
pre dates GLP regulation
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
female
Route of administration:
oral: gavage
Vehicle:
other: aqueous starch
Details on oral exposure:
Apllication: suspension in aqueous starch slurry
Concentration: 25 %
Dose: maximum technically feasible
Doses:
15000 mg/kg
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Fasting: 12 h before treament
- Administration: single gavage
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no data
- Other examinations performed: no data


Sex:
female
Dose descriptor:
LD0
Effect level:
>= 15 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
other: no data
Gross pathology:
no data
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD 50 is expected to be greater then 15000 mg/kg bw.
Executive summary:

The test item was suspended at a concentration of 25 % in an aqueous starch slurry and administered once via gavage to 10 female Wistar rats. Animals weighed 102 - 113 g and were fasted 12 hours before treatment. Rats were observed for 7 days.

Results:

No animal died at the maximum feasible dose of 15 000 mg/kg bw. The LD 50 is expected to be greater then 15000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
2 reliable with restrictions: early study

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

no classification

In an oral acute study no mortality was recorded at a dose of 15000 mg/kg bw.