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Description of key information

The toxicity of the test item on rats was determined in a non-GLP study comparable to OECD 401. The oral LD50 was determined to be >10000 mg/kg bw (test material) in rats under the conditions of the test.

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:
1980-08-01 to 1980-09-01
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Remarks:
Well detailed study with protocol and necroscopy report attached. No information about substance composition.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
- Principle of test: internal guideline: Toxicology SOP No.T1 Acute Oral Toxicity Test in the Rat
GLP compliance:
no
Limit test:
yes
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: C/327/9740/03; provided by study sponsor

FORM AS APPLIED IN THE TEST (if different from that of starting material) :
Test substance administered as 80% (w/v) aqueous solution
Species:
rat
Strain:
other: COBS CD (SD) BR
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Wilmington, Massachusetts, USA
- Weight at study initiation: at least 125 g
- Fasting period before study: 16h before administration
- Housing: wire mesh stainless steel cages, two animals per cage
- Diet (e.g. ad libitum): Rodent Laboratory Chow, Ralston Purina, St. Louis, Mo, USA), ad libitum
- Water (e.g. ad libitum): tap water, ad libitum

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 80% (w/v) aqueous solution of test substance

MAXIMUM DOSE VOLUME APPLIED: 12.5 mL/kg bw
intubation, 80% (w/v) aqueous solution of test substance TGS
Doses:
10 g/kg bw
No. of animals per sex per dose:
10 male
Control animals:
yes
Remarks:
ten animals dosed with tap water 12.5 ml/kg
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: brain, spinal cord and sciatic nerve as well as samples of 25 additional tissues were fixed in a 10% buffered formalin
Statistics:
not applicable
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
no mortality in the 14 day period
Clinical signs:
no untoward symptoms were observed in any of the 10 rats.
Body weight:
no data
Gross pathology:
no gross lesions, no apparent effects attributable to the test substance
Interpretation of results:
GHS criteria not met
Conclusions:
The toxicity of the test item on rats was determined in a non-GLP study comparable to OECD 401. The oral LD50 was determined to be >10000 mg/kg bw (test material) in rats under the conditions of the test.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
10 000 mg/kg bw

Additional information

Justification for classification or non-classification

The LD50 cut-off value was considered to be >10,0000 mg/kg body weight.

According to the Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (including all amendments), the test substance should be classified as non-hazardous for acute toxicity by the oral route.