D-Glucopyranose, oligomeric, butyl glycoside

Endpoint summary

Description of key information

Oral (OECD 423), rat (f): LD50 (cut-off) > 5000 mg/kg bw (limit test)
Dermal (OECD 402), rat (m/f): LD50 > 2000 mg/kg bw (limit test), based on read-across

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:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP - Guideline study

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

17 Dec 2001

Deviations:

no

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

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

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.

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: LD50 experimental

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.

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.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

The available information comprises an adequate and reliable study (Klimisch score 1).

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

The available information comprises adequate, reliable (Klimisch score 2 due to read-across) and consistent studies from reference substances with similar structure and intrinsic properties.

Additional information

There are no data available on the acute dermal toxicity of D-Glucopyranose, oligomeric, butyl glycoside. In order to fulfil the standard information requirements set out in Annex VIII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from structurally related substance is conducted following a category approach.

A detailed justification for the grouping of chemicals and read-across is provided in the technical dossier (see IUCLID Sections 7.1 and 13).

Oral

One acute oral toxicity study in rats is available for D-Glucopyranose, oligomeric, butyl glycoside. In this GLP-study, 6 female Sprague Dawley rats were exposed via gavage to a limit dose of 2000 mg/kg bw in a stepwise procedure (3 rats per step) according to OECD guideline 423 (Phycher Bio-Développement, 2008). No mortality and no adverse effects were observed up to the end of the14-day observation period. Based on the results, the oral LD50 value for female rats was greater than 2000 mg/kg bw. In accordance with OECD guideline 423, the oral LD50 cut-off of the test substance may be considered to be higher than 5000 mg/kg bw.

Dermal

No data are available on the acute dermal toxicity of D-Glucopyranose, oligomeric, butyl glycoside, but two reliable studies of the structurally related category members D-Glucopyranose, oligomeric, C10-16-alkyl glycosides and D-Glucopyranose, oligomers, decyl octyl glycosides (CAS 68515-73-1) exist, which were used for read-across based on the category approach.Both studies were performed according to OECD guideline 402 and in compliance with GLP.

In the acute dermal toxicity study with D-Glucopyranose, oligomeric, C10-16-alkyl glycosides, the test substance was applied at a limit dose of 2000 mg/kg bw on the skin of 5 male and female New Zealand White rabbits for 24 h. Clinical signs of partly hunched posture and slight depression occurred during the observation period. No mortality and no adverse effects including those on the skin were observed during the study period. Therefore, the dermal LD50 value of the test substance for male and female rabbits was greater than 2000 mg/kg bw (Hill Top Biolabs, 1989).

In a similar study performed with the category member D-Glucopyranose, oligomers, decyl octyl glycosides, no substance-related mortalities were observed after dermal application of the test substance at a limit dose of 2000 mg/kg bw in male and female New Zealand White rabbits. Test substance-related clinical changes of emaciation (2/5), nasal discharge (3/5), faecal stains (5/5), yellow area throughout the site of application (5/5) and lacrimation (1/5) occurred in the animals. Irritative effects on the skin in the form of moderate to marked erythema, mild to moderate edema, atopy, desquamation, and mild coriaceousness were most frequently observed within the animals. Based on the result of this study, the dermal LD50 value of the test substance for male and female rabbits was greater than 2000 mg/kg bw (Hill Top Biolabs, 1987).

Inhalation

This information is not available. The substance has a low vapour pressure and is marketed in aqueous formulation; therefore, exposure to vapours or dusts is not to be expected. In addition, reliable data from studies for acute toxicity via the oral route with the substance itself and for acute toxicity via the dermal route performed with structurally related substances according to Regulation (EC) No. 1907/2006, Annex XI, article 1.5 are available.

Justification for selection of acute toxicity – oral endpoint
There is only one study available.

Justification for selection of acute toxicity – inhalation endpoint
No study required since the substance has a low vapour pressure and is marketed in liquid form; therefore, human exposure to vapours or dusts is not to be expected.

Justification for selection of acute toxicity – dermal endpoint
Hazard assessment is conducted by means of read-across based on a category approach and weight of evidence from these studies.

Justification for classification or non-classification

The available data on the acute toxicity of D-Glucopyranose, oligomeric, butyl glycoside and structurally related substances according to Regulation (EC) No 1907/2006, Annex XI, 1.5 do not meet the criteria for classification according to Regulation (EC) No 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.