D-Xylopyranose, oligomeric, 2-octyldodecyl xylosides

Endpoint summary

Description of key information

The study was performed to assess the acute oral toxicity of the test material following a single oral administration in the Sprague-Dawley CD strain rat. The method was designed to meet the requirements of the: OECD Guidelines for the Testing of Chemicals No. 423 “Acute Oral Toxicity — Acute Toxic Class Method” (adopted 17 December 2001).

 

The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated as being greater than 2500 mg/kg bodyweight.

 

The test material does not meet the criteria for classification according to the Regulation (EC) No. 1272/2008.

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 study, oecd guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

Female Sprague-Dawley CD (Cri: CD® (SD) IGS BR) strain rats were supplied by Charles River (UK) Ltd, Margate, Kent, UK. On receipt the animais were randomly ailocated to cages. The animais were nuiliparous and non-pregnant. After an acciimatisation period of at least five days the animais were seiected at random and given a number unique within the study by indelible ink-marking on the tau and a number written on a cage card. At the start of the study the animais were eight to twelve weeks of age. The bodyweights feu within an interval of ± 20% of the mean initial bodyweight ofthe first treated group.
The animais were housed in groups of three in suspended solid-floor polypropylene cages furnished with woodflakes. With the exception of an overnight fast immediately before dosing and for approximately three to four hours after dosing, free access to mains drinking water and food (Certified Rat and Mouse Diet (Code 5LF2) suppiied by International Product Supplies Limited, Weilingborough, Northants, UK) was aliowed throughout the study. The diet, drinking water and bedding were routinely analysed and were considered not to contain any contaminants that would reasonably be expected to affect the purpose or integrity ofthe study.
The temperature and relative humidity were set to achieve limits of 19 to 25°C and 30 to 70% respectively. Any occasional deviations from these targets were considered flot to have affected the purpose or integrity of the study. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and tweive hours darkness.
The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

Ail animais were dosed once only by gavage, using a metal cannula attached to a graduated syringe. The volume administered to each animai was caiculated according to the fasted bodyweight at the time of dosing. Treatment of animais was sequential. Sufficient time was aliowed between each group to confirm the survival ofthe previously dosed animais.

Doses:

2000 mg/ kg bw

No. of animals per sex per dose:

3

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Mortality:

Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0

Clinical signs:

There were no signs of systemic toxicity.

Body weight:

Ail animais showed expected gains in bodyweight over the study period.

Gross pathology:

No abnormalities were noted at necropsy.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated from the flow chart in Appendix 1 as being greater than 2500 mg/kg bodyweight.
The test material does not meet the criteria for classification according to EU labelling regulations Commission Directive 200 1/59/EC.

Executive summary:

Introduction.

The study was performed to assess the acute oral toxicity of the test material foliowing a single oral administration in the Sprague-Dawley CD strain rat. The method was designed to meet the requirements ofthe foliowing: OECD Guidelines for the Testing of Chemicals No. 423 “Acute Oral Toxicity — Acute Toxic Class Method” (adopted 17 December 2001)

Method.

A group of tbree fasted females was treated with the test material at a dose level of 2000 mg/kg bodyweight. This was foilowed by a further group of three fasted females at the same dose level. The test material was administered orally as a solution in arachis ou BP. Clinicai signs and bodyweight development were monitored during the study. Ail animais were subjected to gross necropsy.

Mortality.

There were no deaths.

Clinical Observations.

There were no signs of systemic toxicity.

Bodyweight.

All animals showed expected gains in bodyweight over the study period.

Necropsy.

No abnormalities were noted at necropsy.

Conclusion.

The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated as being greater than 2500 mg/kg bodyweight.

The test material does not meet the criteria for classification according to EU labelling regulations Commission Directive 2001/59/EC.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 500 mg/kg bw

Justification for classification or non-classification

The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated as being greater than 2500 mg/kg bodyweight.

The test material does not meet the criteria for classification according to the Regulation (EC) No. 1272/2008.