Registration Dossier

Administrative data

Description of key information

A single oral dose of 15000 mg/kg did not produce adverse effects in rats.

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:
1970
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: early study; non-GLP; poor sample characterisation and reporting, females only
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
increased limit dose
GLP compliance:
no
Remarks:
predates GLP
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS

- Weight at study initiation: 102-114 g
- Fasting period before study: 16 h
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data


ENVIRONMENTAL CONDITIONS: no data
Route of administration:
oral: gavage
Vehicle:
other: aqueous starch slurry
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 12.5 %
- Amount of vehicle (if gavage): twice 60 ml/kg at 1 hour interval
Doses:
15000mg/kg ( 2 x 7500 mg/kg)
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no data
- Other examinations performed: clinical observations
Sex:
female
Dose descriptor:
LD0
Effect level:
15 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
Animals were inactive after treatment, Faeces were red discolored (test material)
Body weight:
no data
Gross pathology:
no data
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The extreme dose of 15000 mg/kg body weight of the testmaterial did not cause adverse effectes in rats after single oral exposure.
Executive summary:

Ten female rats were treated by gavage with twice with 7500 mg test material per kg body weight at an interval of 1 hour. The test material was suspended in aqueous starch slurry. Clinical observation did not reveal any adverse reactions of the animals. The test material was excreted with the faeces. The LD0 was determined as 15000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
15 000 mg/kg bw
Quality of whole database:
2 (early study, but relevant observations were reported and even the extreme dose did not cause adverse effects)

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 selection of acute toxicity – oral endpoint
Only available study

Justification for classification or non-classification

The LD50 is far above the limit of classification and no classification and labelling is warranted.