D-Glucopyranose, oligomeric, C10-16-alkyl glycosides, 2-hydroxy-3-sulfopropyl ethers, sodium salts

Repeated dose toxicity: oral

Administrative data

Endpoint:

short-term repeated dose toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

13 weeks (90 days)

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Data source

Reference

Reference Type:

review article or handbook

Title:

Unnamed

Year:

2013

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)

Version / remarks:

CIR review does not give full details of this methodology

Principles of method if other than guideline:

Groups of 10 male and 10 female Sprague-Dawley rats were dosed orally, by gavage, with 0, 0.25, 0.5 and I g kg bw for 13 weeks (90 days). 20 An additional 5 male and 5 female control and high-dose rats •were used as a recovery group

GLP compliance:

not specified

Remarks:

CIR review does not give details of the testing laboratory and the GLP status.

Test material

Test material information

Constituent 1

Reference substance name:

D-Glucopyranose, oligomeric, C10-16-alkyl glycosides

Cas Number:

110615-47-9

Molecular formula:

C18H36O6

IUPAC Name:

D-Glucopyranose, oligomeric, C10-16-alkyl glycosides

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

90 days

Frequency of treatment:

Daily

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

0 mg/kg bw/day (nominal)

Doses / concentrations 2

Dose / conc.:

250 mg/kg bw/day (nominal)

Doses / concentrations 3

Dose / conc.:

500 mg/kg bw/day (nominal)

Doses / concentrations 4

Dose / conc.:

1 000 mg/kg bw/day (nominal)

No. of animals per sex per dose:

Groups of 10 male and 10 female Sprague-Dawley rats were dosed orally, by gavage

Control animals:

yes

Results and discussion

Results of examinations

Clinical signs:

effects observed, non-treatment-related

Description (incidence and severity):

No treatment-related changes in bws, organ weights, or biochemistry or hematology parameters were observed. Absolute gonad weights were decreased in all the test groups, but the decrease was not considered treatment related by the researchers because of a lack of a dose response. A dosedependent, slowly reversible, irritation and ulceration of the forestomach mucosa was observed in animals of the 0.5 and I g/kg bw groups. Systemic toxicity was not observed in any group.

Mortality:

no mortality observed

Body weight and weight changes:

no effects observed

Effect levels

Key result

Dose descriptor:

NOAEL

Effect level:

1 000 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: systemic toxicity

Target system / organ toxicity

Key result

Critical effects observed:

no

Applicant's summary and conclusion

Conclusions:

According to the CIR review data, daily doses of 1000 mg test substance per body weight do not leed to systemic toxic effects. This dose can be classified as 'no-observable-adverse-effect-level' for rats.
The no-observed adverse effect level (NOAEL) for systenlic toxicity was I g kg bw. The no-observed effect concentration for "local compatibility" was deduced as 2.5% ai.