D-Glucopyranose, oligomers, branched and linear C9-11-alkyl glycosides

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

D-Glucopyranose, oligomers, branched and linear C9-11-alkyl glycosides

EC Number:

500-394-9

EC Name:

D-Glucopyranose, oligomers, branched and linear C9-11-alkyl glycosides

Cas Number:

157707-87-4

Molecular formula:

not applicable, UVCB substance

IUPAC Name:

not applicable, UVCB substance

Details on test material:

- Name of test material (as cited in study report): Alkyl polyglucoside
- Physical state: No data
- Analytical purity: 50%
- Lot/batch No.: AM-BS

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Shizuoka Agricultural Cooperative Association for Laboratory Animals
- Age at study initiation: 5 weeks
- Weight at study initiation: 105.4-115.1 g (males), 90.3-94.1 g (females)
- Fasting period before study: 17-18 h before administration and 3-4 h after administration
- Housing: 3 animals per cage during the acclimation phase, 5 animals per cage on the day before administration
- Diet: MF, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 2
- Humidity (%):50 ± 10
- Air changes (per hr): 21
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 10% (w/w)
- Amount of vehicle: 2 mL/100 g bw

MAXIMUM DOSE VOLUME APPLIED: 2 mL/100 g bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

other: not required

Details on study design:

- Duration of observation period following administration: 14 days

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: No clinical signs of toxicity were observed up to the end of the observation period.

Gross pathology:

No substance-related abnormalities were noted at necropsy.

Any other information on results incl. tables

Table1. Bodyweights

animal No.	Day after administration(day)
(male)	0	1	2	3	4	7	14	increment
1	105	120	127	136	144	168	220	115
2	115	128	136	144	151	173	226	111
3	109	122	128	132	142	163	213	104
4	109	119	126	133	141	161	209	100
5	111	122	127	135	142	164	216	105
mean	109.8	122.2	128.8	136.0	144.0	165.8	216.8	107.0

animal No.	Day after administration(day)
(female)	0	1	2	3	4	7	14	increment
1	93	102	110	114	119	133	163	70
2	94	107	111	116	122	134	156	62
3	92	102	106	110	115	125	145	53
4	90	100	104	107	111	123	149	59
5	92	101	107	111	115	128	148	56
mean	92.2	102.4	107.6	111.6	116.4	128.6	152.2	60.0

unit : g

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