C12-14 (even numbered) alkyl glycosides, oligomeric and C12-14 (even numbered) alkyl glycosides, oligomeric, carboxymethyl ethers, sodium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2002-07-09 to 2002-08-02

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Guideline Study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

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:

22 March 1996

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

January 1997

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: DIMED Schönwalde GmbH; D-16532 Schönwalde
- Age at study initiation: no data
- Weight at study initiation: 151 - 175 g
- Fasting period before study: approx. 18 h
- Housing: transparent polycarbonate (Macrolon III type) cages; floor area 810 q.cm; two or three each; males and females separated
- Diet: pelleted complete rodent diet "Altromin 1314" from Altromin GmbH; D-32971 Lage, Lippe, Germany, ad libitum
- Water: domestic quality drinking water acidified with hydrochloric acid to pH 2.5 to prevent microbial growth, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 21 +/- 3 °C
- Humidity: 55 +/- 15 %
- Air changes: 10 times per hour
- Photoperiod (hrs dark / hrs light): 12/12; light from 6 am to 6 pm

IN-LIFE DATES: From: 2001-07-09 To: 2002-08-02

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2000 mg/kg bw
- Amount of vehicle (if gavage): 10 mL/kg bw


MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 males/3 females per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations: 1, 3, and 6 hours after administration; thereafter daily for a period of 14 consecutive days. Body weight was recorded on day 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Statistics:

NA

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 was observed during the study

Clinical signs:

other: Females: Animals No. 1, No. 2 and No. 3 showed piloerection 1,3, and 6 hours after the application of the test article. From Day 1 until the end of the observation period on Day 14 no abnormalities were revealed at the three rats. Male: Animals No. 4, No.

Gross pathology:

The gross necropsy on the female and male animals revealed no pathological abnormalities

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance does not need to be classified.

Executive summary:

The test substance has been investigated for its oral toxicity in accordance with OECD guideline 423 under GLP conditions in male and female rats. All animals survived the treatment at the limit dose of 2000 mg/kg bw with slight but reversible signs of toxicosis. The test substance has not to be labelled with regard to oral toxicity.