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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

Oral toxicity: LD50 > 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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The test was performed following official guideline, some details on test conditions are missing. Study meets generally accepted scientific principles, acceptable for assessment.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
not specified
Test type:
other: similar to OECD 401
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS- Age: 5 weeks old- Weight: from 109 g male, 180 g female- Housing: 5 animals per cage - Diet: commercial pelleted diet (Oakes Special diet with added vit. E) ad libitum- Water: ad libitum ENVIRONMENTAL CONDITIONS- Temperature (°C): 21 ± 2- Photoperiod (hrs dark / hrs light): 12 h light / 12 h dark
Route of administration:
oral: gavage
Vehicle:
water
Doses:
15000 mg/kg
No. of animals per sex per dose:
5 males and 5 females
Control animals:
not specified
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 15 000 mg/kg bw
Based on:
act. ingr.
Mortality:
No mortality.
Clinical signs:
No clinical symptoms were recorder.
Body weight:
No data.
Gross pathology:
No damage to any organs.
Other findings:
No data.
Interpretation of results:
practically nontoxic
Remarks:
Migrated informationCriteria used for interpretation of results: other: EU criteria
Conclusions:
The tested item was found to be non toxic for oral exposure with a LD50 > 8600 mg/kg bw.
Executive summary:

The acute oral toxicity in rats of both sexes was assessed with this test over a period of 14 days.

The results show no toxicity with a LD50 value > 15000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
15 000 mg/kg bw

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 tested substance does not show any toxic effect by oral exposure based on the results of the available study.



Justification for classification or non-classification

According to the CLP Regulation (EC n. 1272/2008), table 3.1.1, Acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories:

For Acute toxicity oral route:

Category 1: ATE <= 5 mg/kg bw

Category 2: 5 < ATE <= 50 mg/kg bw

Category 3: 50 < ATE <= 300 mg/kg bw

Category 4: 300 < ATE <= 2000 mg/kg bw

The LD50 of the test substance was determined to be greater than 2000 mg/kg bw in the chosen reference test, which is outside the above criteria. Therefore, the test substance is not classified for Acute toxicity by oral exposure.