D-Glucopyranose, oligomeric, butyl glycoside

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP - Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

17 Dec 2001

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Sécrétariat général du GIPC, Paris, France

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

D-Glucopyranose, oligomeric, butyl glycoside

EC Number:

939-389-5

Molecular formula:

not applicable, UVCB substance

IUPAC Name:

D-Glucopyranose, oligomeric, butyl glycoside

Details on test material:

- Name of test material (as cited in study report): trade name given
- Substance type: tenside
- Physical state: yellow liquid
- Analytical purity: 49.8% solid content
- Purity test date: 15 Apr 2007
- Lot/batch No.: T71531
- Stability under test conditions: responsibility of sponsor
- Storage condition of test material: room temperature
- Other: pH 5.6

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage JANVIER, Le Genest St Isle, France
- Age at study initiation: 8 weeks
- Weight at study initiation: 190-202 g
- Fasting period before study: food removed on day before until 4 hours after test item administration
- Housing: groups of 3 in solid-bottomed clear polycarbonate cages with stainless steel mesh lid. Each cage contained sawdust bedding which was changed at least 2 times a week.
- Diet: pelleted M20 rat/mouse maintenance diet (EXTRALABO from PIETREMENT), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23
- Humidity (%): 32-62
- Air changes (per hr): conventional air-conditioned, not further specified
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE
- Amount of vehicle: 2 mL/kg bw water for control group

MAXIMUM DOSE VOLUME APPLIED: 1.69 mL/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6 females

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 30 min, 1 hour, 3 and 4 hours after dosing and daily thereafter for mortality and behavioural or toxic effects on the major physiological functions (spontaneous activity), Preyer's reflex (noise), respiratory rate, convulsions, tremors, body temperature, muscle tone, palpebral opening, pupil appearance, salivation, lachrymation, righting reflex, back hair appearance. These observations were compared to control data. Weighing was done on Day 0 just before administration and on Days 2, 7, and 14. Weight changes were calculated and recorded.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, other: gross pathological changes of esophagus, stomach, duodenum, jejunum, ileum, caecum, colon, rectum, spleen, liver, thymus, trachea, lungs heart, kidneys, urinary bladder, ovaries, uterus, adrenals, pancreas.

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: LD50 experimental

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: LD50 cut-off according to OECD 423

Mortality:

No mortality occurred.

Clinical signs:

other: No clinical signs related to test item administration were observed.

Gross pathology:

The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.

Any other information on results incl. tables

Conclusion:

The LD50 of the test item is higher than 5000 mg/kg bw by oral route in the rat, in accordance with OECD guideline 423.

According to the criteria of Directive 67/548 EEC and Regulation (EC) No 1272/2008 the test item does not have to be classified.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified