1,6-dichloro-1,6-dideoxy-β-D-fructofuranosyl 4-chloro-4-deoxy-α-D-galactose

Endpoint summary

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

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.